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Ethics statement | This study was approved by the Ethics Committee of Ahvaz Jundishapur University of Medical Sciences (AJUMS) (Ref. ID: IR.AJUMS.REC.1401.280). The objectives, stages, and conditions of the study were fully explained to all participants, and an informed consent form was obtained from each of them. | PMC10169697 |
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Study design | The present study was a randomized controlled study conducted after tool development. It was described according to CONSORT (Consolidated Standards of Reporting Trials) Statement available at | PMC10169697 |
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Settings | This study began in January 2022 and ended in December 2022. The design and development of the AGAH app took about 8 months. Data were collected for 3 months (from October to December 2022) in the operating rooms of 5 university hospitals affiliated with AJUMS. | PMC10169697 |
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Interventions | The 3 stages of this study were design, implementation, and evaluation. Each of these steps is detailed below. | PMC10169697 |
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Design phase | The process of designing the AGAH app is shown in | PMC10169697 |
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Implementation phase | This study was piloted in the operating rooms of 5 university hospitals affiliated with AJUMS from October 2022 to December 2022 (1 academic semester). At the beginning of the semester, second- and third-year nurse anesthesia students were randomly assigned to intervention (AGAH app) and control (paper logbook) groups. Then, the intervention and control groups were matched in terms of their demographic variables. Afterward, in a 2-hour meeting, both groups were separately taught to use their logbooks. Members of the intervention group installed the application on their smartphones, and participants in the control group received their paper logbooks. In another meeting, the clinical instructors were briefed on evaluating and providing feedback, and the supervising professors and department head were familiarized with their supervisory role. The AGAH app was completely consistent with the paper logbook in content and scoring instructions. Over 3 months, the participants in the intervention and control groups documented their skills in the application and the paper logbook, respectively. As soon as the academic semester ended, the logbooks of the control group were collected, and the user accounts of the intervention group members were deactivated in the AGAH app. | PMC10169697 |
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Evaluation phase | The intervention and control groups were evaluated and compared based on the variables of satisfaction and learning outcomes. After the intervention, a post-test satisfaction questionnaire was completed by the members of both groups. The learning outcomes of both groups were measured based on the total score of the procedures recorded in the application and in the paper logbook. | PMC10169697 |
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Participants | All 49 second- and third-year anesthesia nursing students of AJUMS, including 14 men (28.5%) and 35 women (71.5%) with a mean age of 21±3.65 years, entered the study. Sampling was done using the census method, and informed consent was obtained from the participants. Participants were excluded from the study if they failed to record their activities in the application or the logbook, lost the paper logbook, or did not participate in any of the research stages. The data of participants who met the exclusion criteria were not included in the final analysis. | PMC10169697 |
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Outcomes | In this study, the following outcomes were investigated: (1) demographic characteristics, (2) the intervention and control groups’ level of satisfaction with the AGAH app and the paper logbook, respectively, and (3) the learning outcomes of the groups after completing the internship. | PMC10169697 |
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Data sources and measurement | To measure the level of satisfaction of the students, a researcher-made satisfaction questionnaire was used. The first section of this questionnaire dealt with demographic information (age, sex, academic year, and overall grade point average). The second section consisted of 20 items scored based on a 5-point Likert scale (from completely disagree [1 point] to completely agree [5 point]), with a minimum score of 20 and a maximum score of 100. The items examined in this questionnaire included the guide for using the logbook, appearance characteristics, ease of use, speed of evaluation and provision of feedback, impact on motivation, impact on self-confidence, educational communication between the student and the clinical instructor, and speed of correction and improvement of clinical performance. Based on this questionnaire, a score between 20 and 39 represented complete dissatisfaction, 40 to 59 relative dissatisfaction, 60 to 79 relative satisfaction, and 80 to 100 complete satisfaction. After the questionnaire was developed based on textbooks, articles, and other reliable sources, its content validity was confirmed by the faculty members of the AJUMS Department of Anesthesiology and Medical Education using a qualitative approach. Then, the questionnaire was piloted to 30 nursing anesthesia students who were not among the final participants. Their comments were applied to confirm the face validity of the tool. Next, the reliability of the questionnaire was confirmed by an obtained Cronbach α coefficient of 0.96 (The third section of the tool was an anesthesia skills evaluation checklist used in the logbooks, developed and approved by faculty members based on valid anesthesia sources and a literature review ( | PMC10169697 |
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Bias | None. | PMC10169697 |
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Study size | Sample size calculation was performed using G*Power ver. 3.0.10 (University of Düsseldorf), using the independent-samples Student t-test, 2-tailed alpha of 0.05, power (1-β) of 0.80, and effect size (Cohen d) of 0.8. The result indicated that a sample size of approximately 25 participants per group was required. Therefore, all second- and third-year nurse anesthesia students of AJUMS (n=49) were included in the study using the census method. The study included 25 students in the intervention group and 24 students in the control group. | PMC10169697 |
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Randomization | Forty-nine students were randomly assigned to the intervention and control groups. Each student was randomly assigned a code. Then, the codes were placed in a box. The first code drawn from the box conferred assignment to the intervention group, while the second code represented allocation to the control group. This process continued until all students had been selected, at which time 25 students were in the intervention group and 24 in the control group. Subsequently, the intervention and control groups were matched in terms of their demographic variables. The unit of analysis was the same as the unit of assignment (intervention or control). | PMC10169697 |
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Blinding (masking) | No blinding was done. | PMC10169697 |
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Statistical methods | IBM SPSS ver. 25.0 (IBM Corp.) was used for data analysis. The normality of data distribution was confirmed using the Shapiro-Wilk test. Data were analyzed using descriptive (mean, standard deviation, percentage, and frequency) and analytical (independent t-test and chi-square test) statistics. P-values less than 0.05 were considered to indicate statistical significance. | PMC10169697 |
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Results | PMC10169697 |
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Participants | During the 3 months of the study, of the 49 nursing anesthesia students initially participating, only 39 (20 from the intervention group and 19 from the control group) completed all steps of the study ( | PMC10169697 |
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Main results | The independent t-test was used to compare the mean scores for satisfaction and learning outcomes of the intervention and control groups. The results showed a statistically significant difference between the groups in the mean satisfaction score ( | PMC10169697 |
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Discussion | PMC10169697 |
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Key results | The aim of the present study was to design, implement, and evaluate a smartphone-based online electronic logbook (the AGAH app) used to evaluate the clinical skills of nurse anesthesia students in Iran and to compare it with a paper logbook. The results of this study indicated that the mean scores for satisfaction and learning outcomes of the intervention group were significantly higher than those of the control group. | PMC10169697 |
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Interpretation | The present study provides a solid answer to the question of how new and technology-based evaluation methods can constitute a suitable alternative to previous evaluation methods in clinical settings. The results showed that the use of a smartphone-based online electronic logbook could lead to higher satisfaction of nurse anesthesia students relative to a paper logbook. The higher satisfaction with this new method can be explained by the quick access of students to sections on their previous activities, versatility of the online electronic logbook for use across different times and places, high accuracy, user-friendliness, and improved interaction and relationship between the student and the clinical instructor or the department head. In general, new and student-centered methods have been reported to be associated with higher student satisfaction in clinical and educational settings [Various studies have also pointed out numerous advantages of electronic logbooks, aligning with the results of the present study. Among the main advantages of electronic logbooks are the facilitated analysis of recorded data and the easy archiving of information while occupying minimal physical space. This type of logbook also represents an environmentally friendly green technology, which reduces paper consumption. In contrast, paper logbooks are difficult to transport, occupy considerable space, and can make it difficult to analyze a large amount of information [Another finding of the present study was improved performance of the nurse anesthesia students in clinical settings due to the use of the smartphone-based online electronic logbook. In the present study, the purpose of designing an online electronic logbook in particular was to enable quick evaluation of student activity, timely feedback to the student, and constant instructor-student interaction. The findings confirmed our hypothesis that the design of a logbook with the described characteristics could positively impact the clinical performance of nurse anesthesia students. Overall, the importance of formative evaluation and timely feedback is indisputable, as it provides students with sufficient opportunities to improve their performance; this is enabled by online electronic logbooks [ | PMC10169697 |
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Comparison with previous studies | The findings of the present research provide support for previous studies on electronic logbooks. For instance, a study conducted by Tamblyn et al. [The above studies resemble the current research in the demonstrated effectiveness of converting paper logbooks into electronic ones. However, the research population of the previous studies included postgraduate students or residents in various medical specialties, while the target group in the present study was undergraduate students. In addition, the electronic logbooks used in prior studies were mainly web-based, and very few had been developed as smartphone applications. Also, those studies did not utilize or investigate important benefits of online electronic logbooks, such as quick and timely feedback to students. Several of the abovementioned studies involved only analysis of the information in the electronic logbook and reporting of various statistics, and some addressed only the desire and satisfaction of the students. As Straker and Metz [ | PMC10169697 |
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Limitations | Despite its strengths, the present study had a few limitations. First, the low internet speed and frequent disconnections may have affected the results. Additionally, the AGAH app was not compatible with the iOS operating system. Other limitations include the small sample size and the time limit for conducting the study. | PMC10169697 |
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Generalizability | The findings of the present study not only can help optimize the clinical evaluation of nurse anesthesia students, but also may be useful for students of other fields of medical sciences in Iran. The design of the AGAH app allows department heads and professors of other disciplines to define the relevant procedures and activities according to the nature of their field and make desired changes through the AGAH app management panel. | PMC10169697 |
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Suggestions | The present study can be used as a guide to devise cost-effective and up-to-date clinical evaluation methods. Future studies are recommended to investigate the impact of online logbooks (such as the AGAH app) on other variables related to clinical evaluation or among students of other fields of medical sciences. Longitudinal studies with larger sample sizes are expected to yield more definitive results. | PMC10169697 |
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Conclusion | The findings of this study indicate that smartphone technology can be used as a platform for improving the evaluation of nurse anesthesia students’ clinical skills, leading to increased satisfaction and improved learning outcomes. Through the design and development of a smartphone-based online electronic logbook (the AGAH app), the present study enabled online clinical evaluation. This resulted in improved interaction and communication between the student, the clinical instructor, the supervising professor, and the department head.None.
Conceptualization: AK, NJ. Data curation: AK, NJ. Methodology/formal analysis/validation: AK, NJ, SG. Project administration: AK, NJ. Funding acquisition: AK, NJ. Writing–original draft: NJ. Writing–review & editing: AK, NJ, NK, SG.
No potential conflict of interest relevant to this article was reported.
None.
Data files are available from the Harvard Dataverse: Dataset 1. Raw response data from participants for the satisfaction survey.
Dataset 2. Raw rating data from raters for the students’ learning outcomes.
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Supplementary materials | Supplementary files are available from the Harvard Dataverse: Supplement 1. Design phase.Supplement 2. Satisfaction questionnaire.Supplement 3. Example of anesthesia skills evaluation checklist in the paper logbook.Supplement 4. Audio recording of the abstract. | PMC10169697 |
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References | Flowchart of the study.Demographic characteristics of the participants (n=39)Values are presented as number (%) or mean±standard deviation.P-value obtained with the chi-square test.P-value obtained with the independent t-test.Comparison of satisfaction and learning outcome between the intervention and control groups (n=39)Values are presented as mean±standard deviation, unless otherwise stated.P-value obtained with the independent t-test. | PMC10169697 |
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Background | Data on the routine use of video-assisted laryngoscopy in peri-operative intubations are rather inconsistent and ambiguous, in part due to small populations and non-uniform outcome measures in past trials. Failed or prolonged intubation procedures are a reason for relevant morbidity and mortality. This study aims to determine whether video-assisted laryngoscopy (with both Macintosh-shaped and hyperangulated blades) is at least equal to the standard method of direct laryngoscopy with respect to the first-pass success rate. Furthermore, validated tools from the field of human factors will be applied to examine within-team communication and task load during this critical medical procedure. | PMC10111720 |
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Methods | SECONDARY | In this randomized, controlled, three-armed parallel group design, multi-centre trial, a total of more than 2500 adult patients scheduled for perioperative endotracheal intubation will be randomized. In equally large arms, video-assisted laryngoscopy with a Macintosh-shaped or a hyperangulated blade will be compared to the standard of care (direct laryngoscopy with Macintosh blade). In a pre-defined hierarchical analysis, we will test the primary outcome for non-inferiority first. If this goal should be met, the design and projected statistical power also allow for subsequent testing for superiority of one of the interventions.Various secondary outcomes will account for patient safety considerations as well as human factors interactions within the provider team and will allow for further exploratory data analysis and hypothesis generation. | PMC10111720 |
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Discussion | DISEASE | This randomized controlled trial will provide a solid base of data in a field where reliable evidence is of major clinical importance. With thousands of endotracheal intubations performed every day in operating rooms around the world, every bit of performance improvement translates into increased patient safety and comfort and may eventually prevent significant burden of disease. Therefore, we feel confident that a large trial has the potential to considerably benefit patients and anaesthetists alike. | PMC10111720 |
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Trial registration | ClincalTrials.gov NCT05228288. | PMC10111720 |
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Protocol version | 1.1, November 15, 2021. | PMC10111720 |
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Keywords | Open Access funding enabled and organized by Projekt DEAL. | PMC10111720 |
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Background | PMC10111720 |
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Rationale | obese, glottis | OBESE | Endotracheal intubation is the gold standard for airway management under general anaesthesia. Over the course of the past several years, video-assisted laryngoscopy (VAL) has more and more gained in importance in this field and has already found its way into the relevant guidelines for certain settings and situations like the unexpected difficult airway [While video laryngoscopes already significantly expand the field of view simply by positioning the camera, hyper-angulated blades can also accommodate significantly greater curvatures of the pharyngeal anatomy of certain patients where a direct view of the glottis plane would otherwise not be possible [VAL has tended to be superior to direct laryngoscopy in terms of safety in the studies conducted to date, but the quality of evidence based on the existing studies is still insufficient to draw definitive conclusions [A Cochrane systematic review with a total of 64 included studies concluded that primary endotracheal intubation using a video laryngoscope leads to a lower number of failed attempts in emergency scenarios, especially in patients with an expectedly difficult airway [VAL has been included in the guidelines for airway management of the respective professional societies with different recommendations. For the perioperative setting, VAL is mentioned as a back-up procedure in the German guidelines, e.g. in case of an unexpectedly difficult airway after max. two conventional laryngoscopy attempts as well as in obese patients [Going beyond the mere procedure of endotracheal intubation, i.e. inserting a tube in the trachea, this study also aims to descriptively investigate the domain of human factors in the context of critical medical interventions using the example of airway management. In general, this aspect, which examines psychological and physiological influences (among others) on process functioning, is still largely left out of anaesthesiologic research. However, a 2013 study concluded that in all cases in which anaesthesiologists had reported serious airway rescue incidents to a relevant registry, such human factors had contributed to the errors that occurred [The MHPTS consists of 16 individual items that describe a representative number of characteristic nontechnical crew resource management (CRM) behaviours for high-performance teamwork and can be rated using a 3-point scale (0 = never/almost never, 1 = alternating/inconsistent, 2 = constant/consistent). It thus provides a brief, validated, and practical rating scale that can be used by CRM-inexperienced team members in a high-performance medical setting to reflect on important CRM skills and evaluate their own team performance. The NASA-TLX assesses subjectively perceived stress while completing a task on a visual analogue scale (VAS) in six domains [ | PMC10111720 |
Hypothesis and experimental approach | Based on the data available to date, it can be assumed that VAL is at least equivalent to direct laryngoscopy also in the context of elective intubations but could increase patient safety in special situations. Therefore, this trial implements a three-arm, parallel group, randomized-controlled design to investigate the hypothesis that VAL is primarily non-inferior to conventional laryngoscopy in terms of the rate of successful intubations at first attempt. In this study, patients are randomized to one of three parallel study arms: in the first arm, the patient is primarily intubated using conventional, direct laryngoscopy with a Macintosh blade. This intervention, thus far considered the gold standard, also represents the control group. In a second arm, patients will be intubated by VAL, also using a Macintosh-shaped blade. In the third study arm, the primary instrument to be used will be a video-assisted laryngoscope, where primarily and regardless of possibly known difficult airway, a hyper-angulated blade will be used.We hypothesize that the procedure “video-assisted laryngoscopy”, i.e. both VAL study arms taken together in a first analysis step, is non-inferior to the “conventional laryngoscopy” control group regarding the primary endpoint “successful intubation at first attempt”. If this first attempt fails, the decision on the laryngoscopy procedure to be used in the further course is the sole responsibility of the anaesthesiologist performing the procedure; for reasons of patient safety, the study protocol does not contain any provisions in this regard, and the procedure primarily used according to randomization can be abandoned without consequence for study participation. | PMC10111720 |
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Benefit-risk assessment | All patients receive the medically necessary peri-operative care. According to current knowledge, randomization into one of the three study arms does not per se entail any altered risk for participants. Both conventional laryngoscopy and VAL are established as standard clinical procedures. The fact that, according to the current state of knowledge, no procedure is superior to the other for elective endotracheal intubation in the context of general anaesthesia is precisely the subject of this study. There is no evidence from the data available in the literature to suggest that VAL may expose the patient to additional risk compared with the conventional procedure.Since both investigated laryngoscopy procedures are used in routine clinical practice, but sufficient robust data to demonstrate the superiority of either procedure have been lacking to date, the investigation of this issue in a randomized-controlled clinical trial with the aim of maximizing patient safety during a potentially life-threatening intervention also appears to be ethically appropriate. No increased risk results for the patient from participation in this clinical study, neither is a direct medical benefit for the patient assumed resulting from participating. | PMC10111720 |
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Choice of comparators | In this study, three different modalities of laryngoscopy for endotracheal intubation will be compared (s. Fig. Examples of different laryngoscopes to be used in each of the three study arms (from left to right): conventional laryngoscope with Macintosh blade, video-assisted laryngoscope with Macintosh-shaped blade, video-assisted laryngoscope with hyper-angulated bladeAfter testing the non-inferiority of the experimental intervention (VAL as an overall procedure) compared with the control group, pairwise comparisons between the study arms will also be of interest. If this step of the hierarchical analysis plan can be reached, testing for superiority between groups will be possible. Furthermore, the question of whether the primary use of a hyper-angulated blade may be useful can be explored. In this scenario, for example, the hyper-angulated blade would not be inferior in the general setting, but would possibly make a second intubation attempt, or a change of the device used, unnecessary in the case of an unexpectedly difficult airway, since the “rescue device” has already been used to begin with. | PMC10111720 |
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Aims of the study | PMC10111720 |
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Primary aim | The primary aim of this trial is to study whether VAL is non-inferior to conventional laryngoscopy for endotracheal intubation in the context of elective surgery under general anaesthesia. Non-inferiority hereby refers to the average rate of successful intubations at first attempt from all interventions in a study arm. | PMC10111720 |
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Further aims | COMPLICATIONS | In addition, several other parameters will be collected, which, individually or in combination, can provide insights into the risk–benefit profile of the interventions examined. In case of previously proven non-inferiority as laid out in the primary hypothesis, substantial differences between the procedures regarding accompanying injuries, critical changes in vital parameters during intubation, etc., may hint towards a general advantage of one procedure over the others.Furthermore, perceived task load and the quality of the information flow within the team of care providers (mostly anaesthetists and specialist nurses) shall be assessed using structured, validated questionnaires. The underlying hypothesis is that VAL, through the progress of the intubation process being visible to all involved, simplifies supportive or anticipatory measures by the specialist nursing staff and improves the non-verbal information flow.Ultimately, the primary intention of this study is to determine whether there is a generally recommended instrument that is non-inferior in the uncomplicated airway but possibly causes fewer complications in the (unexpected) difficult airway. | PMC10111720 |
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Methods and design | PMC10111720 |
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Design | This is a randomized controlled multi-centre study with a three-arm parallel study design (s. Fig. Flow diagramThe “conventional laryngoscopy” study arm serves as a control group in this experimental setup. The two study arms using VAL will initially be combined at the first stage of the analysis to show that the method “VAL” is non-inferior to the established gold standard regardless of the blades used. If this first analysis can prove non-inferiority, the three individual groups will also be compared against each other. | PMC10111720 |
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Methods | PMC10111720 |
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Setting | Pain | EMERGENCY | The main trial site is the Department of Anaesthesiology, Intensive Care Medicine, Emergency Therapy and Pain Therapy at the University Hospital of Wuerzburg. Further participating sites will be located at the departments of anaesthesiology of hospitals of primary and maximum care in Germany, Austria and Switzerland. Data collection will take place during the induction of anaesthesia prior to elective surgical procedures under general anaesthesia and, after the operation, in the peri-anaesthesiologic ward.Inclusion criteria.Adult patientsScheduled for elective, non-cardiac surgical procedureNeed for endotracheal intubation as determined during the premedication visitCare providers performing the intubation will have at least one year of training in anaesthesiology and sufficient experience in the use of all devices tested.Exclusion criteria.Previous participation in this studyPregnancyNeed for fibreoptic intubationPatients scheduled for bariatric surgeryAny circumstance that will lead the anaesthesiologist(s) in charge to believe (before randomization)That random assignment of a laryngoscopy instrument may compromise patient safety during induction of anaesthesia. | PMC10111720 |
Interventions | ’s mouth, critically ill | EVENT, CRITICALLY ILL | The preparations for induction of anaesthesia as well as establishing the necessary patient monitoring will take place in accordance with the stipulations of the anaesthetist in charge and with local standards. Randomization will take place electronically on the day of the intervention; the randomization result is communicated to the team performing the intervention (i.e. anaesthetist and anaesthesia nurse) in such a way that the patient is unaware of it. The study protocol does not specify the manufacturer or model of the laryngoscope to be used (e.g., disposable vs. reusable blades). However, the kind of blade will be recorded, as previous research suggested considerably reduced glottic view with (disposable) plastic blades compared with metal blades [The choice and dosage of the anaesthetics as well as the sequence of administration is up to the decision of the anaesthetist in charge. For better comparability between the interventions, adequate pre-oxygenation (etO2 > 80%) and relaxation of the patient (ideally, train of four (TOF) = 0) is required before starting the laryngoscopy. The process of laryngoscopy (and thus also the first attempt at intubation) begins when the blade of the laryngoscope passes the patient’s row of teeth for the first time. The trial observer will also start the time measurement for the intubation procedure at this timepoint. The intubation is considered to have been completed successfully when the first capnographic end-expiratory CO2 detection is possible after the endotracheal tube has been placed. In the event of failure, the first attempt at intubation is deemed to have ended at the point in time when either the laryngoscope (e.g., after inadequate visibility of the vocal cords) or the endotracheal tube is removed from the patient’s mouth. Each additional intubation attempt using the same criteria should be considered a completed attempt.The use of an intubation stylet is not primarily intended; the exception here is the use of a hyper-angulated blade, which cannot be used properly without a stylet. The routine use of a stylet for every endotracheal intubation is discussed in the literature in the context of critically ill patients [After completion of the intervention, both the nurse and the anaesthetist in charge will answer the MHPTS questionnaire and the NASA-TLX questionnaire. To ensure that no necessary medical measures are delayed or hindered under any circumstances will be of the essence. | PMC10111720 |
Sample size | The estimation of the appropriate sample size is based on the corresponding Null hypotheses of the primary hypothesis, i.e. the assumption that VAL is inferior to conventional laryngoscopy in terms of first-attempt success rate, irrespective of the kind of blade in use. From clinical experience and previously published data, we assume an a-priori success rate of 90% across all groups. A clinically relevant difference between groups in this context is suggested at 5%, as is the accepted overall type-I error. Given that both Null hypotheses will be tested separately, the type-I error limit in each case is 2.5%. The desired statistical power is set to 90%. The Null hypotheses will be tested for non-inferiority using a one-sided Z test with unpooled variance. Based on these assumptions, the required sample size amounts to 3 * 824 = 2526 participants. | PMC10111720 |
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Recruitment | RECRUITMENT, COMPLICATIONS | Given the large number of surgical interventions performed under general anaesthesia at the study centres involved each day and only little restrictive inclusion and exclusion criteria, insufficient numbers of potential study participants are not to be expected. Because the additional burden on the participants while participating in the study is deemed to be manageable, a high recruitment rate can be assumed. We do not expect substantial problems with protocol adherence due to the short duration of the intervention.Randomization takes place automatically through computer-aided generation of random numbers, which are translated into a randomization decision and will be triggered online by the respective investigator on the day of the intervention at the earliest, so that a concealed allocation to the interventions is ensured (allocation concealment). The randomization result will be communicated non-verbally to the anaesthetist and the nursing staff involved via a display on the tablet monitor to ensure that the patient remains blinded.The generation of the allocation sequences and the allocation to the individual intervention arms takes place via an IT-based system (OpenClinica, Waltham, MA, USA) coordinated by the Center for Clinical Studies of the German Association of Anaesthesiology and Intensive Care (DGAI).If the anaesthetist in charge of the intervention decides not to leave the choice of the intubation instrument to chance for medical reasons before the induction of anaesthesia and prior to randomization, the participation in the trial for this patient and the case will be considered a “screening failure”. If such a decision (deviating from the randomization result) is made after the patient has been randomized but before the start of the first intubation attempt, the first intubation attempt will be.considered to have failed. These cases will be reported separately in the study flow chart. The remainder of intervention as per protocol remains unaffected. After a first intubation attempt with the randomized laryngoscopy device, the anaesthetist performing the procedure is free to change the instrument at his/her own discretion. The required intubation attempts and the time to successful intubation are recorded as described above.In addition, the study protocol does not make any specifications for handling possible complications in securing the airway. The physician carrying out the intervention always has unrestricted authority to make medical decisions to prevent harm to the patient without affecting the patient’s participation in the study. | PMC10111720 |
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Blinding | Patients and data analysts will be blinded regarding the allocation of interventions. The randomization result will be communicated to the care providers non-verbally in such a way that the patient will not take note. Before data will be evaluated, the identifying variable names will be made unrecognizable. For the study observers and the personnel carrying out the intervention, blinding is not possible due to the nature of the study. In the follow-up period two hours after the end of anaesthesia, the survey of the outcomes should be carried out, if possible, by an observer who was not involved in the intervention, to encourage blinding of the investigator here as well. It will be documented whether blinding could be facilitated at this point.Un-blinding of the patient is intended only in cases when an unexpected difficult airway situation occurred, and the patient needs to have an anaesthesia problem card issued for them. However, even in such cases, blinding can usually be kept up until after the last study visit. | PMC10111720 |
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Biometry | The required socio-demographic data as well as data on the surgical procedure will be assessed by chart review beforehand and will be included in the study documentation as source data. All other necessary data are determined and recorded by the investigator or observer during the intervention in real time. The questionnaires on teamwork and task load will be filled out by the care providers as soon as the ongoing procedures allow for. The principal investigator at each study site will be responsible for the timely documentation in the electronic case report form (eCRF) and the proper documentation and storage of source data according to applicable local laws.All data relevant to the trial will eventually be entered into an eCRF and stored in an electronic database provided by OpenClinica LLC (Waltham, MA, USA). Hosting of the database in accordance with German and EU laws will be ensured by Docs In Clouds Telecare GmbH (Aachen, Germany).Data collection forms can be requested from the authors. | PMC10111720 |
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Statistical analysis | H-VAL | EVENTS | The primary outcome is the rate of successful intubations at first attempt as a fraction of dichotomous events. In a first analysis step we test the hypothesis, that neither video assisted laryngoscopy with a Macintosh-shaped blade (M-VAL) nor video assisted laryngoscopy with a hyper-angulated blade (H-VAL) are inferior to conventional direct laryngoscopy (CDL) with regard to the primary outcome. In terms of the statistics, this corresponds to testing the Null hypothesis that at least one of the interventions M-VAL or H-VAL is inferior to CDL. Both Null hypotheses will be tested for separately. The overall type-I error will be set to 5%. Thus, both Null hypotheses will be tested on a local significance level of 0.025 using a one-sided Z-test with unpooled variance. Non-inferiority is defined as described in subsection “sample size”.Only if both Null hypotheses can be rejected will there be a second analysis step where the single interventions M-VAL and H-VAL will be tested pairwise for superiority using a two-sided Z-test with unpooled variance. As we apply the principle of fixed sequence hierarchical testing, this analysis can be performed at a local significance level of 0.05 to meet the family-wise error rate of 0.05.A planned interim analysis will be conducted after 200 randomized interventions. This will first and foremost happen to review feasibility and data quality before expanding to additional study sites. We do not foresee any substantial safety concerns in this trial which would need to be assessed at this stage. | PMC10111720 |
(Serious) Adverse events (SAE / AE) | Death | As all kinds of laryngoscopes and blades used in this study are also widely used in routine clinical practice, we do not expect any trial-specific AEs. However, any definitive failure to successfully place an endotracheal tube using the allocated or subsequently any other device deemed suitable shall be documented as an AE. This could be the case when a supraglottic airway device is used without further attempts to facilitate endotracheal intubation or when anaesthesia is being terminated early while bag-and-mask-ventilating the patient.An SAE is present if one or more of the following occur:Death during the observation periodVital threat to the patientNeed for previously not planned in-patient treatment or prolongation thereofOccurrence of persisting or severe disabilityAEs and SAEs must be reported to the sponsor as soon as possible and be recorded in the eCRF. | PMC10111720 |
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Ethics, data privacy and data availability | All activities within this trial comply with the Declaration of Helsinki and the principles of Good Clinical Practice (GCP). | PMC10111720 |
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Ethics approval | The German version of this protocol was approved by the Ethics committee at the Medical Faculty, University of Wuerzburg, Germany (No. 215/21-sc). Any protocol amendments or supplements require review by the responsible ethics committee and will be communicated to the study centres after approval by the committee. | PMC10111720 |
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Informed consent | Informed consent will be obtained by trained investigators at the respective study sites. The necessary information material and consent forms will be provided by the sponsor of the trial. Patients who are not capable of giving consent and those under legal custody are excluded from participation in the study. | PMC10111720 |
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Data privacy | Personal data of patients are collected only to the extent required by the study protocol. All data collected through observation of the intervention will be collected in a pseudonymized manner. Only excerpts from the anaesthesia protocol for documentation of vital signs during the intervention will be directly assignable to individual patients and will be processed and stored in accordance with the applicable national and EU data protection regulations and the principles of Good Clinical Practice. Data of the care providers will be collected anonymously. Detailed information for participants on collecting, processing, and storing trial data will be part of the patients’ information brochure. | PMC10111720 |
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Data availability | The final data set will remain property of the sponsor. Other parties will not be entitled to have access to the data. The sponsor reserves the right to make individual or all primary data available in anonymized form to other scientists upon request for the purposes of reviewing the conducted and performing own subsequent analyses.Publication of the results of this study in peer-reviewed medical journals will be pursued. Authorship guidelines as put forth by the International Committee of Medical Journal Editors (ICMJE) will be adhered to. | PMC10111720 |
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Roles and responsibilities | In this investigator-initiated trial, the trial sponsor is involved in the study design. Researchers concerned with the preparation of this protocol, data collection and eventually seeking to publish the results are in part employed by the sponsor. The sponsor retains ultimate authority over these activities. | PMC10111720 |
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Discussion | sore throat, hoarseness, trauma | SORE THROAT, SECONDARY, RECRUITMENT, BLIND | We propose here the protocol for a randomized, controlled, patient-blinded multi- centre trial on the routine use of VAL in a peri-operative anaesthesiologic setting. Although several studies in the broader research area have been conducted in the past, conclusive evidence enabling clear recommendations is still not available. As Lewis et al. pointed out in a Cochrane systematic review on the matter, there is high heterogeneity in the findings [Despite our best efforts to design this study as diligently and efficiently as possible, some points of concern still remain. For one, there will always be an issue with the inability to blind the interventionist regarding the intervention allocation. It is well conceivable that the physician performing endotracheal intubation will always be aware of the device they are using. In analogy to this, the outcome assessor cannot be blinded for similar reasons. Therefore, there will always be a risk for performance or detection bias. We will, however, have patients and statisticians blinded, thus avoiding additional potential bias where possible.With a recruitment goal of more than 2,500 patients, we needed to assure that the observation period stays as compact and short as possible. To meet a comprehensive set of outcome parameters which allows for proper comparability with previous studies, we incorporated in this trial a follow-up two hours after the end of surgery to assess additional outcomes like hoarseness and sore throat. However, we decided not to extend the follow-up period for possible endpoints like hospital length of stay or mortality. We do not foresee any fundamental issues or inconveniences in recruiting the projected number of patients. Due to the nature of the inclusion and exclusion criteria, many patients will be eligible for participation and with a sufficiently large number of additional study sites we expect to meet the recruitment goal within two years. This is needed to ensure that the accompanying circumstances remain reasonably constant during the conduct of the study.With the results from this trial, we aim to contribute a substantial foundation of evidence for the use of VAL in the routine peri-operative setting. We intentionally designed this study as a non-inferiority trial. In a mostly unselected population like this one, overall first attempt success rates for intubation are (fortunately) high to begin with. We cannot with reasonable certainty expect to see VAL superior in this regard, although with the choden statistical design this would be possible to prove as well. However, with the ORs of patient-relevant secondary outcomes like laryngeal/airway trauma, sore throat and hoarseness previously reported to tend to favour VAL (OR [95% CI] 0.68 [0.48, 0.96], 0.82[0.56, 1.19] and 0.57 [0.36, 0.88], respectively [ | PMC10111720 |
Funding | Pain | EMERGENCY | This trial is funded through departmental funds of the Department of Anaesthesiology, Intensive Care, Emergency and Pain Medicine Pain, University Hospital Wuerzburg, and supported by the German Society for Anaesthesiology and Intensive Care. | PMC10111720 |
Acknowledgements | Not applicable | PMC10111720 |
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Authors’ contributions | BS contributed to the design of the trial, analysed and interpreted the data, and drafted and revised the manuscript. DE, AM and PP contributed to the design of the trial and acquired the data. UM performed the sample size calculations and drafted the statistical analysis plan. MB and OH contributed to the design of the trial. PM and PK contributed to the design of the trial and the interpretation of the data and revised the manuscript. The author(s) read and approved the final manuscript. | PMC10111720 |
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Funding | Pain | EMERGENCY | This publication was supported by the Open Access Publication Fund of the University of Wuerzburg. Open Access funding enabled and organized by Projekt DEAL. This trial is funded through departmental funds of the Department of Anaesthesiology, Intensive Care, Emergency and Pain Medicine Pain, University Hospital Wuerzburg, and supported by the German Society for Anaesthesiology and Intensive Care. | PMC10111720 |
Availability of data and materials | Data will be available upon request from the corresponding author after completion of the trial. A model consent form and patients’ information as well as the Mayo High Performance Teamwork Scale and NASA-TLX questionnaires (all in German) as used in this trial can be obtained from the authors upon request. | PMC10111720 |
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Declarations | PMC10111720 |
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Ethics approval and consent to participate | All activities within this trial comply with the Declaration of Helsinki and the principles of Good Clinical Practice (GCP). This protocol was approved by the responsible ethics board:Ethics Committee of the Medical Faculty, University of Wuerzburg, ref. 215/21-sc, Jan 18, 2022.Informed consent will be obtained by trained investigators at the respective study sites. The necessary information material and consent forms will be provided by the sponsor of the trial. Patients who are not capable of giving consent and those under legal custody are excluded from participation in the study. | PMC10111720 |
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Consent for publication | Not applicable. | PMC10111720 |
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Competing interests | The authors declare no competing interests. | PMC10111720 |
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References | PMC10111720 |
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Background and objectives | idiopathic frozen shoulder, pain | FROZEN SHOULDER | Frozen shoulder (FS) is characterized by pain and significant loss of active and passive shoulder motion. Strengthening exercises are among the standard exercises used for FS. Neuromuscular exercise (NME) effectively improved pain and the range of motion in shoulder. However, no prior research has looked into the effects of NME compared to strengthening exercises in FS rehabilitation. The aim of the present study was to evaluate the effects of NME compared to strengthening exercises on pain and active range of motion (AROM) in individuals with idiopathic frozen shoulder. | PMC9854051 |
Methods | idiopathic frozen shoulder | Forty individuals with idiopathic frozen shoulder were randomly assigned to either the experimental group (NME with regular physical therapy, | PMC9854051 |
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Results | Two-by-two mixed analysis of variance (ANOVA) revealed a significant group × time interaction for VAS (F = 29.67; | PMC9854051 |
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Conclusions | idiopathic FS, rotation and external rotation, pain | NME is superior to strengthening exercises in terms of pain and AROM of shoulder flexion, internal rotation and external rotation in individuals with idiopathic FS. NME could be used to treat individuals with FS. | PMC9854051 |
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Trial registration | Trial registration number: ChiCTR2100054453. Registration date: 17/12/2021. | PMC9854051 |
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Supplementary Information | The online version contains supplementary material available at 10.1186/s12891-023-06173-8. | PMC9854051 |
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Keywords | PMC9854051 |
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Introduction | fibrosis, pain | DISEASE, FIBROSIS, ADHESIVE CAPSULITIS, FROZEN SHOULDER, PROGRESSIVE INFLAMMATION | Frozen shoulder (FS) or adhesive capsulitis is an unknown intrinsic disease associated with spontaneously progressive inflammation and fibrosis of the shoulder joint capsule, characterised by pain and significant loss of active and passive shoulder motion [Sensory and proprioceptive input may be reduced if the shoulder cannot be moved due to pain in FS [As for comparing the effects of NME and strengthening exercises for the shoulder, Eshoj et al. [Therefore, the aim of the current study was to compare the effects of NME and strengthening exercises at FS. We hypothesised that NME may improve the symptoms of FS better than strengthening exercises. | PMC9854051 |
Materials and methods | PMC9854051 |
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Study design | MAY | This was a single-blinded, randomised controlled trial conducted in the rehabilitation medicine department of a regional hospital. Forty participants were recruited from December 2021 to May 2022. They were randomly assigned to either NME plus regular physical therapy (experimental group) or regular physical therapy with strengthening exercises (control group). Assessment was performed at baseline and 8 weeks after the intervention (Fig. CONSORT flow diagram | PMC9854051 |
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Randomization and blinding | Eligible participants were randomly assigned to the experimental or control group by a blinded investigator using computer-generated random numbers through concealed opaque envelopes. An independent blinded therapist assessed participants and collected data at baseline and 8 weeks after treatment. After the baseline examination, another blinded therapist opened the envelope and started the therapy according to the group assignment. | PMC9854051 |
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Participants | idiopathic FS [, idiopathic frozen shoulder, shoulder pain | ADHESIVE CAPSULITIS | Forty participants who have been diagnosed with idiopathic frozen shoulder were recruited from a regional hospital for this study. The inclusion criteria include: (1) FS (adhesive capsulitis) diagnosed at the freezing or frozen stage. (2) symptoms such as shoulder pain, stiffness and joint mobility limitations (limited range of motion of the shoulder in abduction, flexion, extension, internal or external rotation). (3) age over 40 years. (4) unilateral idiopathic FS [ | PMC9854051 |
Interventions | Participants in both the experimental group (EG) and the control group (CG) performed a 5-minute warm-up exercise in the form of wall climbing at the beginning and received 40 minutes of regular physical therapy. Participants from CG performed 20 minutes of strengthening exercises. Participants in EG performed NME for 20 minutes. | PMC9854051 |
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Regular physical therapy | Regular physical therapy included Maitland mobilization techniques, stretching exercises and active range of motion exercises [ | PMC9854051 |
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Strengthening exercises | rotation and external rotation, abduction | Strengthening exercises included isometric and isotonic exercises. Theraband isometric exercises and 1–2-kg dumbbells isotonic exercises were performed for flexion, extension, abduction, internal rotation and external rotation in a standing and lying position. Ten seconds/set, 10 sets for each direction for isometric exercises. 10 repetitions/set, 3 sets for each direction for isotonic exercises. 5 seconds rest between two sets [ | PMC9854051 |
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NME | abduction | NME used the HUBER360NME for the left shoulder in external rotationNME for the left shoulder in abduction 90° and external rotationNME for the left shoulder in flexion 90° and external rotation | PMC9854051 |
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Outcome assessments | shoulder flexion, abduction, pain | After the treatment and at the beginning of the study, all outcomes were assessed. The same experienced therapist collected data on basic demographic factors such as age, gender, duration of symptoms, stage, affected side and clinical outcomes such as pain and active range of motion (AROM).Pain intensity was assessed using the visual analogue scale (VAS), which ranks pain from 0 (no pain) to 10 (most severe pain) and has good reliability with an intraclass correlation coefficient (ICC) of 0.71–0.99. The standard error of measurement (SEM) of VAS was 0.03 and the minimum detectable change (MDC) was 0.08 [The shoulder active range of motion (AROM) including flexion (FL), extension (EX), abduction (AB), external rotation (ER), and internal rotation (IR) was measured with a two-arm standard goniometer with a good reliability (ICC 0.91 to 0.99) [For each movement, three measurements were recorded, and the mean was used for statistical analysis. In the standing posture, shoulder flexion and abduction were assessed. In the prone position, shoulder extension was measured with the elbow flexed to 90°. In the prone position, shoulder internal rotation was measured with the shoulder abducted to 90° and the elbow flexed to 90°. Finally, in the supine position, the external rotation of the shoulder was measured with the shoulder abducted to 90° and the elbow flexed to 90° [ | PMC9854051 |
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Sample size calculation | The sample size calculation was based on the time-by-group interaction of a two-by-two mixed analysis of variance (ANOVA). The effect size was estimated to be 0.25 with 80% power and an α-value of 0.05. G*Power v.3.1.9.2 was used for this calculation. The estimated required sample size was 17 individuals per group. Considering the potential for loss, we aimed to recruit 20 participants per group. | PMC9854051 |
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Statistical analysis | All statistical analyses were performed using SPSS version 19.0 | PMC9854051 |
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Discussion | pain | This study aims to investigate the effects of NME compared to strengthening exercises on pain intensity and AROM in individuals with FS. Significant improvements in VAS, AROM of flexion, internal rotation, and external rotation in the experimental group have been observed in this study. | PMC9854051 |
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Evaluation of the effect of neuromuscular exercise on pain | pain | The results show that pain intensity improved significantly in individuals with FS after an intervention of 40 sessions of NME plus regular physical therapy. These results are consistent with the results of other studies [ | PMC9854051 |
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Evaluation of the effect of neuromuscular exercise on AROM | CHRONIC SHOULDER PAIN | A significant difference was found in the AROM of flexion, internal rotation, and external rotation between the group with NME plus regular physical therapy and the group with regular physical therapy plus strengthening exercises. Shoulder AROM improved after 5 weeks of neuromuscular control exercises in subjects with chronic shoulder pain, as reported by Ginn et al. [ | PMC9854051 |
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Limitations of the study | First, the sample size in this study was relatively small. Second, it is unclear whether the frequency, intensity, and duration of NME by the motorized device were the best in this study, and there is no previous study to compare it with. Third, only the VAS score and AROM of the shoulder were measured in this study, and no disability questionnaires were reported. Finally, no long-term effect of NME was observed at FS. Therefore, further studies with a larger sample and different frequencies, intensities, and durations on long-term and functional effects are desirable. | PMC9854051 |
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Conclusions | pain | FROZEN SHOULDER | This study shows that NME performed with a motorized device in combination with regular physical therapy in the form of joint mobilization, stretching, and AROM at FS is more effective for pain relief and improvement of AROM compared with regular physical therapy with strengthening exercises. Considering the positive effects on FS, it is recommended that NME could be used in the treatment of individuals with FS. However, the long-term and functional effects of NME on frozen shoulder need to be investigated in future large-scale studies. | PMC9854051 |
Suppliers |
Huber360 MD; LPG Systems.SPSS; IBM Corp. | PMC9854051 |
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Acknowledgements | We would like to thank every individual who participated in this study. | PMC9854051 |
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Authors’ contributions | L.W. and Y.C. designed the research study. L.W. participated in the data collection/analysis and writing of the manuscript. G.Y., R.Z., G.W., L.H. participated in the data collection and analysis. Y.C. provided experimental guidance during the study and revised the paper critically. All authors read and approved the final manuscript. | PMC9854051 |
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Funding | The study did not receive any specific funding from funding agencies in the public, commercial or non-profit sectors. | PMC9854051 |
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Availability of data and materials | The datasets used and analyzed during the current study are available from the corresponding author on reasonable request. | PMC9854051 |
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Declarations | PMC9854051 |
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