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Exclusion criteria | rheumatoid arthritis, psychopathy, systemic infections | RHEUMATOID ARTHRITIS, CARDIAC DISEASES, CONTAGIOUS DISEASES, CHRONIC FATIGUE SYNDROME, KIDNEY DISEASES, PULMONARY DISEASES, MALIGNANT TUMORS, SYSTEMIC INFECTION, LIVER DISEASES, ANKYLOSING SPONDYLITIS | Individuals with knee-related conditions such as rheumatoid arthritis, fibromyalgia syndrome, chronic fatigue syndrome, and ankylosing spondylitis were not included in the study. Additionally, individuals who met the following criteria were also excluded.Those who had taken steroid medication or undergone acupuncture/moxibustion treatment in the last 3 months.Those who had received intra-articular hyaluronate injections within the past 6 months.Those who had undergone arthrocentesis or arthroscopy in the last year.Those with a history of knee/hip replacement surgery or plans for such surgery during the trial.Those using other external treatments, such as topical medications.Individuals with serious medical conditions, including cardiac diseases, pulmonary diseases, kidney diseases, liver diseases, malignant tumors, systemic infections, contagious diseases, or psychopathy.Those who had used the study treatment in the previous 30 days.Individuals who had previously participated in other laser therapy trials.Participants recruited simultaneously for another clinical trial.Those unable to complete measurement questionnaires. | PMC10666435 |
Randomization and blinding | A total of 392 eligible participants were divided into two groups: the LM group and the sham LM group. The allocation of patients to these groups was determined through a computer-generated randomization sequence. The subjects were assigned numbers based on the order in which they completed the forms. A statistician generated a random sequence of numbers using the seed number 2605 in the STATA/SE11 software. The random sequence comprised random numbers, which were then sorted either in ascending or descending order based on their magnitude. The original codes associated with the sorted order were utilized as the basis for grouping. In order to maintain the confidentiality of this randomization process, the central randomization system generated letter codes (designating either LM equipment or sham LM equipment), which were then transmitted to the field coordinator. Once the equipment operator received the equipment code from the current field coordinator, they used the equipment bearing that code to treat the patient. It is important to note that both types of equipment emitted the same red light during operation, making it impossible for the operator to discern which group the equipment belonged to. The entire procedure was closely monitored by the coordinator to ensure that the study adhered to the established protocol. Trained operators administered treatment to both groups in a dedicated room to prevent any communication among patients. Consequently, no one involved in the study, including patients, equipment operators, outcome assessors, study coordinators, and statisticians, was aware of the treatment assignments. | PMC10666435 |
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Intervention | PMC10666435 |
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CO | In this clinical study, the SX10-C1 CO | PMC10666435 |
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Duration and method of treatment | Participants were positioned in a supine posture with both knees exposed and padded below the popliteal fossa using a small pillow to maintain a slightly bent and relaxed position. Two specific acupoints were chosen, namely the Dubi point (ST35, situated on the outer side of the patella and in the recess of the patellar ligament) and the Ashi point (a tender point) in the affected knee [ | PMC10666435 |
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Outcome | The fasting 15-m walking time was recorded prior to the intervention, during Week 4, and at Week 12. | PMC10666435 |
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Statistical methods | The statistical analysis of the data involved was conducted using SPSS version 22.0 software. To assess whether the data followed a normal distribution, the Wilcoxon test was employed. If the data exhibited a normal distribution, it was presented as the mean ± standard deviation. Alternatively, for data that did not adhere to a normal distribution, it was presented as median values (Q1, Q3). Gender and knee condition comparisons between groups were conducted using the Chi-squared test, while general measurement data comparisons utilized the | PMC10666435 |
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Discussion | pain, knee joint injuries, TCM, KOA | OSTEOARTHRITIS, SYNDROME, DYSFUNCTION | KOA, referred to as “Knee Arthralgia” in traditional Chinese medicine (TCM), falls under the category of “Bi syndrome” in TCM [Building on this foundation, we conducted a randomized, double-blind controlled trial involving LM. After a four-week treatment period, we observed significant improvements in pain symptoms in individuals with KOA, as indicated by the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) score (Furthermore, our research team conducted separate randomized, double-blind, and controlled clinical trials for moxibustion and LM. Both interventions led to a substantial improvement in the fastest walking time (46 m or 50 yards) for patients with KOA before and after treatment. Consequently, we posit that LM enhances the walking ability of patients with KOA by alleviating pain and enhancing cartilage health. Our primary research objective is to investigate whether LM can influence the shortest walking time. The current method for detecting the fastest walking time involves having patients walk 50 yards as fast as possible. However, this can lead to knee joint injuries, pain, and falls in patients, causing them to be reluctant to participate in the test and dropping out. In the early stages of our study, we decided to make the test safer and more reflective of the walking abilities of patients with KOA. As a result, we conducted the fastest walking time test over a shorter distance of 15 m in this study. This approach also revealed a correlation between the fastest walking time over a short distance and the pain and other symptoms experienced by patients with KOA, as indicated by previous studies [The primary factors contributing to reduced walking ability in these patients are pain, stiffness, and dysfunction in the knee joint. Therefore, the key to their treatment lies in reducing inflammatory pain, alleviating stiffness, and enhancing knee function. Our study demonstrated that in the LM group, the fastest 15-m walking time was significantly shorter at Week 4 and Week 12 compared to before treatment. In contrast, there were no significant differences in the fastest walking time before and after treatment or between Week 4 and Week 12 in the sham LM group. When comparing the two groups, it is evident that the LM group showed greater improvement in the fastest walking time compared to the sham LM group. This indicates that LM treatment effectively enhances the fastest walking time over 15 m in patients.On the other hand, sham LM did not result in any improvement in the fastest walking time. There were no significant differences observed before and after the end of treatment or at Week 4 and Week 12 in this group. These findings suggest that LM treatment has a lasting effect on KOA treatment, with improved walking ability persisting for at least 8 weeks after treatment completion. Future research could explore the specific duration of this efficacy through longer follow-up periods.Overall, the study results highlight the significance of the 15-m walking distance as a means to assess the walking abilities of patients with KOA. The fastest 15-m walking test not only enhances the efficiency of healthcare providers but also encourages greater patient compliance, reduces risks, and supports its broader adoption and clinical application. This research, however, is subject to several limitations. Beginning with the fact that the research was conducted in six separate sites with differing numbers of recruited participants in each, selection bias and conditional bias could be introduced. Furthermore, in TCM, acupoint selection is based on the concepts of syndrome classification, whereas in this therapy, we only used two fixed acupoints. Furthermore, although patients were instructed to keep a drug use diary, we cannot guarantee that this instruction was followed to the letter. Although we believe randomization can solve this problem by guaranteeing that both groups have an equal number of participants, our requirements might not be followed exactly. As a result, we plan to adopt tougher techniques for regulating fundamental drug usage of patients in future studies and to more closely link our methodologies with clinical practice. | PMC10666435 |
Acknowledgements | The authors would like to thank the patients in this study for their cooperation and commitment. | PMC10666435 |
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Author contributions | SXY was involved in conception and design of the research and obtaining financing. Z.L., C.K., W.F, and L.L. were involved in acquisition of data. C.K., W.F., and L.L. analyzed and interpreted the data. C.L.S. performed statistical analysis and wrote the manuscript. Z.L. and S.X.Y. were involved in critical revision of the manuscript for intellectual content. All authors read and approved the final draft. | PMC10666435 |
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Funding | This trial was supported by the National Natural Science Foundation of China (81320108028) and the National Program on Key Basic Research Project of China (2015CB554505). | PMC10666435 |
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Availability of data and materials | The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request. | PMC10666435 |
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Declarations | PMC10666435 |
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Ethical approval and consent to participate | All procedures performed in studies involving human patients were in accordance with the ethical standards of the Ethical and Scientific Committee of Six hospitals with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. Specifically, the IRBs that approved the study were the IRB of Shuguang Hospital affiliated with Shanghai University of Traditional Chinese Medicine (reference: 2014-341-37-01), the IRB of Shanghai East Hospital affiliated with Tongji University (reference: 2013-24), the IRB of Renji Hospital affiliated with Shanghai Jiaotong University (reference: 2015-001), the IRB of Shanghai Changning Tianshan Traditional Chinese Medicine Hospital (2017TSKY04), and the IRB of Shanghai Tongren Hospital affiliated with Shanghai Jiaotong University (reference: 2017-32). Shanghai Hudong Hospital accepted the ethics approval granted by Shuguang Hospital. Informed consent was obtained from all patients included in the study. Details that might disclose the identity of the patients under study were omitted. | PMC10666435 |
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Consent for publication | Not applicable. | PMC10666435 |
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Competing interests | The authors declare that they have no competing interests. | PMC10666435 |
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References | PMC10666435 |
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Background | Aerobic exercise promotes cognitive function in older adults; however, variability exists in the degree of benefit. The brain-derived neurotropic factor (BDNF) Val66Met polymorphism and biological sex are biological factors that have been proposed as important modifiers of exercise efficacy. Therefore, we assessed whether the effect of aerobic exercise on executive functions was dependent on the BDNFval66met genotype and biological sex. | PMC10069071 |
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Methods | SECONDARY | We used data from a single-blind randomized controlled trial in older adults with subcortical ischemic vascular cognitive impairment (NCT01027858). Fifty-eight older adults were randomly assigned to either the 6 months, three times per week progressive aerobic training (AT) group or the usual care plus education control (CON) group. The secondary aim of the parent study included executive functions which were assessed with the Trail Making Test (B–A) and the Digit Symbol Substitution Test at baseline and trial completion at 6 months. | PMC10069071 |
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Results | Analysis of covariance, controlling for baseline global cognition and baseline executive functions performance (Trail Making Test or Digit Symbol Substitution Test), tested the three-way interaction between experimental group (AT, CON), BDNFval66met genotype (Val/Val carrier, Met carrier), and biological sex (female, male). Significant three-way interactions were found for the Trail Making Test (F(1,48) = 4.412, | PMC10069071 |
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Conclusions | vascular cognitive impairment | VASCULAR COGNITIVE IMPAIRMENT | These results suggest that future randomized controlled trials should take into consideration BDNF genotype and biological sex to better understand the beneficial effects of AT on cognitive function in vascular cognitive impairment to maximize the beneficial effects of exercise and help establish exercise as medicine for cognitive health. | PMC10069071 |
Highlights | vascular cognitive impairment | VASCULAR COGNITIVE IMPAIRMENT |
Aerobic training improves cognitive health and identifying biological moderators of aerobic training will maximize the precision of exercise as medicine for cognitive health.The common BDNFval66met polymorphism and biological sex interact to moderate the cognitive-enhancing effects of aerobic training in older adults with vascular cognitive impairment, with female Val/Val carriers benefitting the most.Future randomized controlled trials of exercise should take into consideration genotype and biological sex of participants | PMC10069071 |
Keywords | PMC10069071 |
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Background | vascular cognitive impairment, ischemic strokes, gait disturbances, white matter hyperintensities | VASCULAR COGNITIVE IMPAIRMENT, ISCHEMIC STROKES, WHITE MATTER HYPERINTENSITIES | Evidence supports aerobic training (AT) as a strategy to improve cognitive health, with the strongest evidence seen in older adults and for executive functions [It is hypothesized that one possible pathway through which AT benefits cognition is the induction of the brain-derived neurotrophic factor (BDNF) cascade, which supports neuroplasticity and the cellular mechanisms required for learning [Of relevance, a common functional single-nucleotide polymorphism exists within the pro-domain region of the BDNF gene resulting in an amino acid substitution of valine (Val) to methionine (Met) at position 66, termed the Val66Met substitution, and may influence exercise efficacy in a sex-dependent manner. The Met allele alters intracellular trafficking of the precursor form of BDNF, reducing the activity-dependent secretion of the mature form of BDNF [No intervention study of AT has examined the interaction of the BDNFval66met polymorphism and biological sex on cognition. Findings from observational studies are equivocal. Sanders et al. [Subcortical ischemic vascular cognitive impairment (SIVCI) is the most common form of vascular cognitive impairment in which covert ischemic strokes manifest as white matter hyperintensities, resulting in declines in executive functions, memory, language, gait disturbances, and increased falls [Therefore, we analyzed data collected from a single-blind randomized controlled trial (NCT01027858) to assess whether the effect of a 3x/week progressive AT intervention on executive functions and processing speed in participants with SIVIC [ | PMC10069071 |
Methods | PMC10069071 |
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Study design | The data for this analysis originated from a 26-week randomized controlled trial at the University of British Columbia campus at the Vancouver General Hospital. The primary findings and methods of this randomized controlled trial are published [ | PMC10069071 |
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Participants | Alzheimer’s Disease, Stroke | DISORDERS, STROKE | All participants were recruited from the University of British Columbia Hospital Clinic for Alzheimer’s Disease and Related Disorders, the Vancouver General Hospital Stroke Prevention Clinic, and specialized geriatric clinics in Metro Vancouver, Canada. A complete description of the inclusion and exclusion criteria can be found in [ | PMC10069071 |
Descriptive and demographic variables | Baseline age, sex, education level, weight (kg), height (cm), body mass index (kg/m | PMC10069071 |
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Executive functions | We previously found a sex-dependent effect of AT on the executive function of set-shifting using the Trail Making test in SIVCI adults [Biological sex interacts with the BDNFval66met polymorphism to influence Digit Symbol Substitution Test [ | PMC10069071 |
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Experimental groups | PMC10069071 |
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Aerobic Training group (AT) | Classes were led by certified fitness instructors, were 60-min in duration (10-min warm-up, 40-min walking, 10-min cool down), and occurred 3×/week for 6 months. Adherence was monitored by recording class attendance. The AT intensity was monitored via heart rate monitors as well as the 20-point Borg Rating of Perceived Exertion [ | PMC10069071 |
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Usual care plus education group (CON) | VASCULAR COGNITIVE IMPAIRMENT | Participants in the CON group attended monthly education classes given by a registered dietician and read materials pertaining to vascular cognitive impairment and healthy diets. Information regarding exercise and physical activity were not provided. | PMC10069071 |
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Genotyping | Peripheral whole blood samples were collected in BD Vacutainer lavender top blood collection tubes at baseline and were stored at − 80 °C. DNA was extracted from whole blood using an automated DNA extraction machine (AutoGen FLEX STAR, Hollisten, MA). Genotyping of the BDNFval66met polymorphism (GenBank dbSNP: rs6265) was performed with TaqMan SNP assay (C-11592758-10) in an optimized ABI 7300 (Applied Biosystems). Due to the low frequency of the Met/Met genotype in the population (less than 5%), the established convention in the field was followed and Met/Met and Val/Met participants were combined into a single group. | PMC10069071 |
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Statistical analyses | SECONDARY | The statistical package SPSS 23.0 (IBM Corporation Armonk, NY) was used to conduct analysis of covariance to evaluate the main effects of and interactions between experimental group (AT, CON), BDNF genotype (Val/Val carrier, Met carrier), and biological sex (female, male) for the primary (i.e., Trail Making Test) and secondary (i.e., Digit Symbol Substitution Test) outcomes. Baseline Montreal Cognitive Assessment score and baseline score for the outcome variable were entered as covariates in all analysis of covariance models. Analyses were conducted as complete case analyses. Where there was a significant interaction effect, posthoc analyses were then performed using a Bonferroni correction, accounting for the overall correlation between the two measures of executive functions, the Trail Making Test and Digit Symbol Substitution Test. To interpret the three-way interaction of experimental group*BDNF genotype*biological sex, we conducted posthoc comparisons between AT and CON groups in male and female Met carriers and Val/Val carriers separately. Effect sizes for significant results were calculated as partial eta squared (η | PMC10069071 |
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Results | PMC10069071 |
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Sample description | Of the 71 participants enrolled in the original trial, the present analyses are based on 58 of those participants that completed the trial with BDNF genotyping (Fig. CONSORT diagram for the flow of participants in a randomized controlled trialBaseline characteristics of male and female BDNF Val/Val carriers and Met carriers in the two experimental groups, mean (standard deviation)Baseline characteristics of participants in the parent (full) sample and the complete case sample, mean (standard deviation) | PMC10069071 |
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Sex and genotype dependent effect of aerobic training on executive functions | Table There was a significant three-way interaction between experimental group, BDNF genotype, and sex [F(1,48) = 4.412, Total time taken to complete the Trail Making Test (B–A) in seconds at trial completion, adjusted for baseline Montreal Cognitive Assessment and baseline Trail Making Test (B–A) scores. A 6-month aerobic training program significantly improved performance in female brain-derived neurotrophic factor (BDNF) Val/Val carriers and decreased performance in male BDNF Val/Val carriers compared with a usual care plus education control program. No difference was seen in female and male Met carriersA significant three-way interaction was observed between experimental group, BDNF genotype, and sex [F(1,47) = 10.833, Total score on the Digit Symbol Substitution Test at trial completion, adjusted for baseline Montreal Cognitive Assessment and baseline Digit Symbol Substitution Test scores. A 6-month aerobic training program significantly improved performance in female brain-derived neurotrophic factor (BDNF) Val/Val carriers and decreased performance in female BDNF Met carriers. No difference was seen in male Val/Val or Met carriersOverall, analyses indicate that 6 months of AT increases performance on two tests of executive functions compared to CON in female BDNF Val/Val carriers (see Figs. | PMC10069071 |
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Discussion | Alzheimer’s disease, dementia, Heras | Results from this randomized controlled trial provide preliminary evidence that BDNFval66met genotype interacts with biological sex to influence AT efficacy on executive functions in older adults with SIVCI, a clinical population with increased dementia risk. Specifically, we found that engaging in 6 months of AT compared with usual care and education control led to improvements on the Trail Making test (set-shifting) and Digit Symbol Substitution Test (working memory, sustained attention, and processing speed) in female Val/Val carriers. AT decreased performance on the set-shifting test in male Val/Val carriers and decreased performance on the working memory, sustained attention and processing speed test in female Met carriers compared with control.While the evidence for engaging in exercise to promote cognition is mounting [Our findings regarding the effect of AT on executive functions in Val/Val carriers are in line with prior observational studies that found the association between physical activity and executive functions was mainly evident in Val/Val carriers, though biological sex was not examined in these studies. For example, on tests of the executive function of conflict resolution, Val/Val carriers that were physically active performed better than inactive Val/Val carriers [As outlined by de las Heras and colleagues [Previous work suggests that the effect of BDNFval66met polymorphism on hippocampal blood flow, age-related cognitive and brain volume decline, and Alzheimer’s disease risk is sex-dependent [ | PMC10069071 |
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Limitations | As is the case with most studies examining the effects of polymorphisms on cognition, our analyses are limited by the small number of male and female BDNF Met allele carriers. The Met allele is found in 30–70% of the population, depending on ethnicity [ | PMC10069071 |
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Author contributions | CKB and TLA outlined and executed the analyses in this manuscript and drafted the manuscript. SYS helped with data analysis and contributed to the writing of the manuscript. GYRH and RT provided intellectual input and were involved in data collection for the primary RCT. All authors read and approved the final manuscript. | PMC10069071 |
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Funding | Stroke | HEART, ALZHEIMER, STROKE, BROWN | Teresa Liu-Ambrose is a Canada Research Chair (Tier 1) in Healthy Aging. Cindy Barha is a Alzheimer’s Association and Brain Canada Postdoctoral Fellow. This study was funded by the Canadian Stroke Network, the Heart and Stroke Foundation of Canada, and the Jack Brown & Family Alzheimer’s Research Foundation, and the Canadian Institutes of Health Research (AWD-016347, PJT-148902) TLA. | PMC10069071 |
Availability of data and materials | The data sets used and analysed during the current study are available from the corresponding author on reasonable request. | PMC10069071 |
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Declarations | PMC10069071 |
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Ethics approval and consent to participate | Ethics approval was obtained from the Clinical Research Ethics Board at the University of British Columbia (H07-01160). All participants provided written informed consent. | PMC10069071 |
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Consent for publication | Not applicable. | PMC10069071 |
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Competing interests | The authors declare that they have no competing interests. | PMC10069071 |
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References | PMC10069071 |
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Background | POSTOPERATIVE ATELECTASIS | To compare the effects of laryngeal mask mechanical ventilation and preserved spontaneous breathing on postoperative atelectasis in children undergoing day surgery. | PMC10626763 |
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Methods | Children aged 3–7 who underwent elective day surgery were randomly divided into a spontaneous breathing group ( | PMC10626763 |
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Results | atelectasis | ATELECTASIS | The incidence of atelectasis in the spontaneous breathing group was 91.30%, and 39.13% in the mechanical ventilation group, and the difference was statistically significant ( | PMC10626763 |
Conclusion | postoperative atelectasis, reflux | POSTOPERATIVE ATELECTASIS, COMPLICATIONS, REFLUX | Laryngeal mask mechanical ventilation can reduce the incidence and severity of postoperative atelectasis in children undergoing day surgery, and we didn’t encounter any complications such as reflux and aspiration in children during the perioperative period, so mechanical ventilation was recommended to be used for airway management. | PMC10626763 |
Trial registration | The clinical trial was registered retrospectively at the Chinese Clinical Trial Registry. ( | PMC10626763 |
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Keywords | PMC10626763 |
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Introduction | postoperative pulmonary complications, reflux, Atelectasis, supraglottic airway, atelectasis, pulmonary infection | REFLUX, ATELECTASIS, ATELECTASIS, PULMONARY INFECTION, PERIOPERATIVE COMPLICATION, POSTOPERATIVE ATELECTASIS, COMPLICATIONS | Atelectasis is a common perioperative complication. It has been reported [Day surgery refers to operations that require the participation of anesthesiologists within 24 h from admission to discharge. These children were hospitalised for a shorter period of time for observation and are prone to complications such as pulmonary infection after discharge due to the presence of atelectasis. Therefore, it is important to pay more attention to postoperative atelectasis in children who underwent day surgery.Laryngeal mask is a supraglottic airway tool, which has been commonly used in clinical because of its non-invasiveness, less damage, and easy to insert. Now, the use of laryngeal mask instead of tracheal intubation for airway management has been achieved in day surgery, therefore, how to performe a respiratory management with a laryngeal mask is particularly important.It was reported that muscle relaxants may lead to an increase in postoperative pulmonary complications, and laryngeal mask retention of spontaneous breathing can reduce the incidence of reflux aspiration, so laryngeal mask retention of spontaneous breathing has become a common method of respiratory management for children [ | PMC10626763 |
Materials and methods | cryptorchidism | CARDIOPULMONARY DISEASE, RESPIRATORY INFECTION, DISEASE, NEUROMUSCULAR DISEASE, PULMONARY ATELECTASIS, DIRECT INGUINAL HERNIA | This study was performed at the Children’s Hospital of Nanjing Medical University from April to August 2022 and was approved by the Ethics Committee of the Children’s Hospital of Nanjing Medical University (approval number: 202112124–1). Inclusion criteria: 1) Children aged 3 ~ 7 years, ASA class I or II, undergoing day surgery, with cryptorchidism and indirect inguinal hernia as the disease type, and open surgery as the surgical method, 2) Operation time < 2 h. Exclusion criteria: 1) preoperative respiratory infection, 2) severe cardiopulmonary disease, 3) overweight (more than 20% of standard body weight), 4) neuromuscular disease, 5) abnormal preoperative chest radiograph or chest CT, inflammatory parameters, 6) the child’s guardian did not agree to participate in this trial, 7) preoperative lung ultrasound suggested the presence of pulmonary atelectasis, 8) after removal of the laryngeal mask, the patient’s SpO2 < 90%. | PMC10626763 |
Randomization and blinding | Group allocation was concealed in sequentially numbered, opaque, sealed envelopes that were opened by trained study personnel. Each envelope contained the group allocation and instructions for the attending anaesthesiologist. Weiwei Cai generated the random allocation sequence, Huanhuan Ni enrolled participants, and Longde Zhao assigned participants to interventions. Weiwei Cai was blinded after assignment to interventions and performed the second lung ultrasound examination. Finally 46 children were randomly divided into spontaneous breathing group ( | PMC10626763 |
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Anesthesia | An intravenous route was established before the patient was brought to the operating room. An electrocardiogram, pulse oxygen saturation, blood pressure, end-tidal carbon dioxide, respiratory rate and body temperature were monitored after entering the operating room. A standard anesthetic protocol was used for all patients, including midazolam 0.05 mg-kg | PMC10626763 |
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Lung ultrasound examination | pulmonary atelectasis, atelectasis | PULMONARY ATELECTASIS, LUNG, ATELECTASIS | Lung ultrasound was performed twice before the induction of anesthesia and 20 min after the removal of the laryngeal mask. The lung ultrasound was performed by a specialist anesthetist trained in lung ultrasound with an M7series ultrasound machine (Shenzhen Myriad Biomedical Electronics Co., Ltd.). A 4–10 MHz line array probe was selected and the lung ultrasound was performed in the supine and lateral positions as described by Acosta et al. [Partition of lung ultrasoundAtelectasis was divided into four grades under lung ultrasound (Fig. Ultrasound images of pulmonary atelectasis and grading of atelectasis | PMC10626763 |
Outcome variables | postoperative atelectasis, atelectasis, reflux | POSTOPERATIVE ATELECTASIS, ATELECTASIS, COMPLICATIONS, REFLUX | The primary outcomes were the incidence of postoperative atelectasis (Because grade 1 atelectasis is easy to recover, only patients with grade 2 or higher atelectasis were included in the calculation of the incidence of atelectasis) and the postoperative atelectasis score. Secondary outcomes were baseline data, duration of anesthesia, duration of surgery, vital signs at three-time points including after insertion of the laryngeal mask, intraoperative (10 min after the start of the operation), and before the removal of the laryngeal mask. In addition, whether encounter complications such as reflux aspiration etc. were also recorded. Vital signs mainly including respiratory rate, heart rate, blood pressure, PetCO | PMC10626763 |
Study sample size and statistical analysis | atelectasis | ATELECTASIS | Our sample size was calculated using data obtained from pre-test results, the incidence of atelectasis in the spontaneous breathing group was approximately 90% and in the mechanical ventilation group was 40%. The sample size was calculated using G Power software, the require sample size was at least 22 patients in each group, with a set α error of 0.05, a power of 0.9. And a 10% loss to follow-up was also considered. Therefore, we enrolled 23 patients in each group.SPSS 23.0 software was used for analysis. Normally distributed measurement data were expressed as mean ± standard deviation and a t-test for independent samples was used for comparison between groups. Skewed distribution data were expressed as median (quartile [full range]) and a non-parametric test was used for comparison between groups. Quantitative data were compared using the | PMC10626763 |
Acknowledgements | Not applicable. | PMC10626763 |
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Authors’ contributions | Weiwei Cai is the first author, he designed the study, peformed the research, analysed most of the data and wrote the paper. Wei Gu was responsible for data analysis. Huanhuan Ni and Longde Zhao were responsible for data collection. Shan Zhong and Wei Wang were correspondence author and they were contributed equally to this work. All authors read and approved the final manuscript. | PMC10626763 |
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Funding | Not applicable. | PMC10626763 |
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Availability of data and materials | The datasets used and/or analysed during the current study available from the corresponding author on reasonable request. | PMC10626763 |
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Declarations | PMC10626763 |
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Ethics approval and consent to participate | The experimental protocol was established, according to the ethical guidelines of Helsinki Declaration and was approved by the Ethics Committee of the Children’s Hospital of Nanjing Medical University (approval number: 202112124–1). Written informed consent was obtained from guardian participants. | PMC10626763 |
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Consent for publication | Not applicable. | PMC10626763 |
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Competing interests | The authors declare no competing interests. | PMC10626763 |
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References | PMC10626763 |
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Background | bleeding, abdominal injuries, trauma | BLEEDING | Previous observational studies showed higher rates of abdominal wall closure with the use of hypertonic saline in trauma patients with abdominal injuries. However, no randomized controlled trials have been performed on this matter. This double-blind randomized clinical trial assessed the effect of 3% hypertonic saline (HS) solution on primary fascial closure and the timing of abdominal wall closure among patients who underwent damage control laparotomy for bleeding control.
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Methods | abdominal injuries, DCL | Double-blind randomized clinical trial. Patients with abdominal injuries requiring damage control laparotomy (DCL) were randomly allocated to receive a 72-h infusion (rate: 50 mL/h) of 3% HS or 0.9 N isotonic saline (NS) after the index DCL. The primary endpoint was the proportion of patients with abdominal wall closure in the first seven days after the index DCL. | PMC9830760 |
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Results | The study was suspended in the first interim analysis because of futility. A total of 52 patients were included. Of these, 27 and 25 were randomly allocated to NS and HS, respectively. There were no significant differences in the rates of abdominal wall closure between groups (HS: 19 [79.2%] vs. NS: 17 [70.8%]; | PMC9830760 |
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Keywords | PMC9830760 |
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Introduction | injuries, abdominal trauma | Since patients with abdominal trauma often present severe injuries and impaired physiology, they tend to require damage-control abdominal surgery followed by damage-control resuscitation [A potential intervention to reduce the volume of intravenous fluids infused without putting resuscitation in peril is hypertonic saline (HS) infusion [ | PMC9830760 |
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Methods | PMC9830760 |
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Setting, study design, and oversight | FVL, trauma | DEL | This double-blind, randomized, placebo-controlled trial was conducted at Fundación Valle del Lili (FVL) University hospital between November 2015 and August 2018. The FVL is a fourth-level university hospital equivalent to a US-level I trauma center, and it has 523 beds. Of these, 205 are ICU beds and 10 are reserved for trauma patients. The FVL trauma center admits approximately 700 moderate-to-severe trauma patients per year, serving as one of the largest trauma referral centers in the southwest region of Colombia.The trial protocol was registered in clinicaltrials.gov (identifier: NCT02542241). The protocol was designed by the Trial Steering Committee and was reviewed and approved by the FVL ethical and biomedical research committee. Written informed consent was obtained from all patients or another surrogate decision-maker. Consent by an independent physician and deferred consent was used as a surrogate to subject consent when appropriate. In these cases, the trial team performed the randomization following pre-specified trial protocol criteria and then requested for the patient’s or representative’s (proxy) informed consent in a later phase.An independent committee and the staff from the FVL clinical research center regularly monitored the trial to check for protocol compliance and data transparency. | PMC9830760 |
Patients | bleeding, hypothermia, traumatic injuries, hemoperitoneum, hyperlactatemia, abdominal injuries, intra-abdominal organ injuries, DCL, metabolic acidosis, trauma | METABOLIC ACIDOSIS, BLEEDING, HEMOPERITONEUM | Adult patients with traumatic injuries were eligible for the study if they were to undergo damage control abdominal surgery in the index laparotomy. Specific inclusion criteria were: 1. informed consent obtained before any trial-related activities, 2. age above or equal to 18 years at the time of inclusion, and 3. patients with blunt or penetrating trauma and requiring DCL for abdominal injuries. The decision to perform an emergent laparotomy was taken by the attending trauma surgeon at the emergency department in patients with signs of exsanguination/hemodynamic instability, acute abdomen or evisceration. When in the operating room, patients underwent a DCL (involving surgical control of bleeding and contamination plus packing with laparotomy pads plus leaving the abdominal wall open) if there was evidence of hypothermia, metabolic acidosis or hyperlactatemia (reflecting physiological exhaustion), hemoperitoneum and/or destructive intra-abdominal organ injuries. A detailed description on how we approach and provide surgical treatment to patients with abdominal injuries requiring damage-control surgery at our institution is described elsewhere [ | PMC9830760 |
Exclusion criteria | death, traumatic injuries, traumatic brain injury, post-traumatic intrabdominal infections, postoperative bleeding, DCL, deaths, trauma | POSTOPERATIVE BLEEDING | Patients were excluded if the time between the occurrence of his/her traumatic injuries and the randomization was longer than four hours, had a severe traumatic brain injury, and had a high probability of death in the first 48 h. Although the treating surgeon subjectively determined this, the decision was based on what is known about the epidemiology of deaths after trauma [Patients were also excluded if the indications for performing a DCL were different from the initial trauma (i.e., DCL in the context of post-traumatic intrabdominal infections, patients in whom the abdomen was closed at the index surgery but required an emergent relaparotomy for postoperative bleeding or control of contamination). Pregnant women were also excluded. | PMC9830760 |
Study protocol | organ injury, DCL, trauma | COMPLICATIONS | Patients in both study groups received trauma care in the emergency department and the operating group following current clinical practice guidelines and institutional protocols. After the decision to perform a DCL, patients underwent randomization in a double-blind manner. Randomization was performed in permuted blocks of four and six by an independent statistician using Random Allocation Software® [According to their allocation, the patients received a 72-h infusion (rate: 50 mL/h) of 3 N hypertonic saline or 0.9 N isotonic saline after the index damage control laparotomy. The infusion was administered in the intensive care unit. The presentation of the study solutions was similar. Neither the treating group nor the patients nor the investigators could discern their composition. The treating team made decisions regarding other fluids, blood components, vasopressors, inotropic support, or monitoring according to the usual practice. The study infusion was considered at all times when planning and executing fluid resuscitation. Double-blind was achieved by the use of similar appearing saline bags in the two groups.Decisions regarding the timing of the reoperations and the abdominal closure were made by the surgical team according to the need for reconstruction of specific lesions, the occurrence of complications, and the fluid balance. In each patient, the surgeons worked to reconstruct the lesions and close the abdomen as early as possible.The protocol for organ injury management and abdominal wall closure has been previously published [ | PMC9830760 |
Study end points and definitions | intra-abdominal hypertension, organic dysfunction | ABDOMINAL COMPARTMENT SYNDROME, DYSFUNCTION, INTRA-ABDOMINAL HYPERTENSION | The primary endpoint of the trial was the proportion of patients with abdominal wall closure in the first seven days after the index surgery.Secondary endpoints were: 28-day mortality, the fluid balance during the first 72 h, the proportion of patients requiring reoperation for intra-abdominal hypertension, the proportion of patients with abdominal compartment syndrome (defined as sustained intra-abdominal pressure > 20 mm Hg and a new organic dysfunction), the proportion of patients with organic dysfunction, defined as a Sequential Organ Failure Assessment (SOFA score) > 2 [ | PMC9830760 |
Statistical analysis | ® | The trial was designed on the assumption of the superiority principle to have 80% power with a The trial team had full access to the data and was responsible for the analysis. All analyses were performed in a blinded manner so that investigators could not know if subjects were assigned to the control or treatment group.Statistical analyses were performed on Stata 15.1® (College Station, Tx). Categorical variables are presented as frequencies and percentages. The normality of continuous variables was examined by the Shapiro–Wilk test. Afterward, they are presented as mean and standard deviation or median and interquartile rank.Categorical variables were compared with ChiInterim analyses were planned at enrollment of 50, 100, 200, and 300 patients, with predefined termination criteria for futility or effectivity [ | PMC9830760 |
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Early termination of the clinical trial | hypernatremia | HYPERNATREMIA | After recruiting the first 50 cases, an independent statistician performed the first interim analysis. A power of 0.09 was found, and a conditional power of 0.34 was calculated for the planned sample size. The 95% CI for the RR at this level would have been 0.99–1.27. The recalculation of the sample size at the same p and power, with the observed parameters, resulted in 1102 patients. With this information and the observation of a high proportion of patients developing hypernatremia in one of the groups, the data and safety monitoring board recommended stopping the trial. | PMC9830760 |
Limitations | Our study has limitations. First, the small number of patients available for analysis limits the results’ generalizability despite the randomization. Second, one of the most obvious shortcomings of this study is its potentially limited external validity derived from its single-center nature. Third, related to its low sample size, the trial certainly had a likelihood of type II error (declaring no differences between groups when, in fact, these differences exist). Thus, it could be argued that the study lacks sufficient power and should be interpreted as presenting inconclusive findings. However, we have presented the steps we followed to stop the trial, suggesting that completing the sample size would not have guaranteed reaching statistical significance. | PMC9830760 |
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Conclusion | HYPERNATREMIA | This randomized clinical trial showed no benefit of hypertonic saline solution in primary fascial closure rates. Patients randomized to HS had higher sodium concentrations after the first day and were more likely to present hypernatremia. We do not recommend using HS in patients undergoing damage control laparotomy.
| PMC9830760 |
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Acknowledgements | The authors of this manuscript want to thank the Clinical Research Center staff for their constant support. | PMC9830760 |
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Author contributions | JCP | Trial design: AFG, GAOT, and JCP. Writing of the trial protocol: AFG. Screening, randomization, and follow-up of the patients: MPN, JCY, JGB, and RMN. Statistical analyses: AFG and AIS. Critical evaluation of the results: AFG, DCC, AIS, JHM, GAOT, CAO, and JCP. Writing of the first draft of the manuscript: AFG and RMN. All authors made relevant intellectual contributions to the manuscript, and all authors approved the final version for journal submission. All authors read and approved the final manuscript. | PMC9830760 |
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Funding | The author(s) received no financial support for the research, authorship, and/or publication of this article. | PMC9830760 |
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Availability of data and materials | The datasets generated and/or analyzed during the current study are not publicly available due to privacy concerns but are available from the corresponding author on reasonable request. | PMC9830760 |
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Declarations | PMC9830760 |
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Competing interests | The authors declare no competing interests. | PMC9830760 |
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Ethics approval and consent to participate | DEL | All research involving human participants reported in the present randomized controlled trial was performed in accordance with the declaration of Helsinki and was approved by the ethical and biomedical research committee at Fundación Valle del Lili University Hospital. | PMC9830760 |
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Consent for publication | DEL | Written informed consent was obtained from patients or another surrogate decision-maker before any trial-related activities. The informed consent process was approved by the ethical and biomedical research committee at Fundación Valle del Lili University Hospital. | PMC9830760 |
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Competing interest | The authors declare that they have no competing interests. | PMC9830760 |
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References | PMC9830760 |
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Background | pain | Evidence regarding the analgesic effect of distraction through immersion in virtual reality (VR) for care-induced pain has been documented in several phase 2 trials, but comparison with standard treatments in large, randomized studies is needed. | PMC9978987 |
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Objective | In this open-label, multicenter, randomized, phase 3 trial, we evaluated the safety and efficacy of a novel VR therapy solution for distraction in the context of bone marrow biopsy. | PMC9978987 |
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Methods | anxiety, pain | Bliss is a VR software with 4 imaginary interactive environments in 3 dimensions with binaural sound (head-mounted display). Efficacy regarding pain intensity was evaluated using a visual analog scale (VAS; score from 0 to 10) immediately after the biopsy. Secondary end points were anxiety and tolerance. Modified intention-to-treat analysis was performed. | PMC9978987 |
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Results | malignant hemopathy, hemopathy, –1.6, pain | MAY | Overall, 126 patients with previously documented untreated or suspected malignant hemopathy between September 6, 2018, and May 18, 2020, were randomly assigned in a 1:1 ratio to receive pain prevention with a mixture of nitrous oxide/oxygen (MEOPA; n=63) or VR (n=63) before and during the bone marrow biopsy. We excluded 8 patients from the final analysis (3 in the MEOPA group and 5 in the VR group). All patients received local anesthesia (lidocaine) before biopsy. Follow-up was limited to 1 month after the biopsy. Participants’ median age was 65.5 (range 18-87) years, and 54.2% (64/118) of patients were male. The average pain intensity was 3.5 (SD 2.6, 95% CI –1.6 to 8.6) for the MEOPA group and 3.0 (SD 2.4, 95% CI –1.7 to 7.7) for the VR group, without any significant differences in age, sex, center, and hemopathy ( | PMC9978987 |
Conclusions | pain | The intensity of pain did not significantly differ between both arms. VR was well tolerated, and the satisfaction of patients, nurses, and physicians was very high. VR could be an alternative treatment in case of contraindication or intolerance to MEOPA. | PMC9978987 |
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Trial Registration | ClinicalTrials.gov NCT03483194; https://clinicaltrials.gov/ct2/show/NCT03483194 | PMC9978987 |
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