## Protocol Section
### Identification Module
**NCT ID:** NCT05043779

**Brief Title:** Evaluation of Preoperative Nasoendoscopy to Predict Difficult Intubation

**Official Title:** Is Preoperative Awake Airway Nasoendoscopy A Good Tool To Predict The Expected Difficult Airway In Obese Patients?

#### Organization Study ID Info
**ID:** MRC-01-19-107
#### Organization
**Class:** INDUSTRY
**Full Name:** Hamad Medical Corporation
### Status Module
#### Completion Date
**Date:** 2022-03-01

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** RECRUITING
#### Last Update Post Date
**Date:** 2021-09-14

**Type:** ACTUAL

**Last Update Submit Date:** 2021-09-05

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2022-03-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2020-08-12

**Type:** ACTUAL

**Status Verified Date:** 2021-07

#### Study First Post Date
**Date:** 2021-09-14
**Type:** ACTUAL
**Study First Submit Date:** 2021-07-28
**Study First Submit QC Date:** 2021-09-05
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Hamad Medical Corporation

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Despite the availability of different methods for airway assessment, unexpectedly difficult intubations occur at a frequency of up to 15%. A variety of pre-intubation clinical screening tests have been advocated to predict difficult laryngoscopy and airway but their usefulness is limited in obese patients.

Could awake invasive airway assessment be more predictive for difficult airways in obese patients? The use of nasendoscopy assessment for the airway could be a useful additional invasive tool to predict the difficult airway in obese

**Detailed Description:** Predictors of difficult laryngoscopy and intubation may be less useful or irrelevant when there is a plan for video laryngoscopes (VL) intraoperative. VL improves laryngeal view in most patients, Their use achieves a high success rate for intubation of patients with predicted difficult intubation, and those who have failed direct laryngoscopy\[6\]. In a study of over 2000 (VL) video laryngoscopies intubations, Mallampati's score did not correlate with failed intubation. The strongest predictor of failure was neck pathology, including the presence of a surgical scar, radiation changes, or mass. In another study, risk factors for difficult VL intubation after direct laryngoscopy were Cormack-Lehane grade 3 or 4 views with direct laryngoscopy, short sternothyroid distance, and high upper lip bite test score. Obesity is a recognized risk factor for difficulty with airway management. An audit of major complications of airway management (NAP4) from over three million anesthetics in the United Kingdom found twice as many case reports of major complications in obese patients, especially in the morbidly obese.

It is less clear whether obesity increases the risk of difficult laryngoscopy or intubation. Some studies suggest that obesity is a risk factor for both difficult mask ventilation and difficult laryngoscopy, while other studies suggest that with proper positioning and preparation, ventilation and laryngoscopy are not difficult \[12,13\]. Wilson's score is an important development in predictivity of airway difficulties, Wilson's in his study (1988) attempted to deductively identify patients for whom intubation will be difficult.

This study aims to demonstrate the use of preoperative awake fibreoptic examination

### Conditions Module

**Conditions:**

- Difficult or Failed Intubation

- Obesity, Morbid

**Keywords:**

- Nasoendoscopy,

- Obesity,

- Difficult intubation

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** DIAGNOSTIC

#### Enrollment Info

**Count:** 30

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** only one arm

**Intervention Names:**

- Procedure: Awake Airway Nasoendoscopy

**Label:** Preoperative Awake Airway Nasoendoscopy

**Type:** OTHER

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Preoperative Awake Airway Nasoendoscopy

**Description:** Preoperative Awake Airway Nasoendoscopy of upper airway

**Name:** Awake Airway Nasoendoscopy

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** Findings will be recorded and scored according to NOHL (N=nose, O= oral, H= hypopharynx and L= Larynx ) every parameter takes a score from 1- 4 during pre-operative assessment.(the maximum values score = 16 and the minimum = 4)

**Measure:** Naso-endoscopy views from nose to larynx in obese patients using NOHL score during pre-operative assessment.

**Time Frame:** During pre-operative assessment.

#### Secondary Outcomes

**Description:** This will be measured by centimeter during pre-operative assessment using a ruler

**Measure:** Measurement of neck circumference in Centimeter

**Time Frame:** During pre-operative assessment.

**Description:** This will be measured by centimeter between incisors during pre-operative assessment using a ruler and documented by Centimeter

**Measure:** Mouth opening measurement by Centimeter

**Time Frame:** During pre-operative assessment.

**Description:** This will be measured by centimeter from thyroid cartilage to patient's chin during pre-operative assessment using a rule

**Measure:** Thyro-mental distance measurement by Centimeter

**Time Frame:** During pre-operative assessment.

**Description:** Degree of Difficulty in mask ventilation will be graded (1= easy, 2= difficult or 3=impossible) during induction of general anaesthesia

**Measure:** Difficult mask ventilation score (1 -3)

**Time Frame:** During Induction of anesthesia

**Description:** Cormak-Lehans Score will graded during endotracheal intubation and exposure of the larynx. (Grade 1= easy intubation while grade Grade 4= very difficult intubation)

**Measure:** Cormak-Lehans grade during induction of anaesthesia

**Time Frame:** During intubation

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Adult patients between 18-60 years of age either male or female with (ASA I, II or III ), scheduled for a bariatric procedure with a body mass index (BMI) greater than 35 K/M2, will be enrolled

Exclusion Criteria:

* Patients on the tracheostomy tube
* Patients who are unable to give consent

**Maximum Age:** 60 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** nshallik@hamad.qa

**Name:** nabil Shallik, M.D.

**Phone:** 9745543926

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Doha

**Contacts:**

***Contact 1:***

- **Email:** nshallik@outlook.com

- **Name:** Nabil Shallik, M.D.

- **Phone:** 55439284

- **Role:** CONTACT

***Contact 2:***

- **Name:** Mohamed A. Elarref, M.D.

- **Role:** PRINCIPAL_INVESTIGATOR

***Contact 3:***

- **Name:** Mayed Radi, M.D.

- **Role:** SUB_INVESTIGATOR

***Contact 4:***

- **Name:** Olfa Al Mannai, M.D.

- **Role:** PRINCIPAL_INVESTIGATOR

***Contact 5:***

- **Name:** Adnan Saad Eddin, MBBcH

- **Role:** SUB_INVESTIGATOR

***Contact 6:***

- **Name:** Yasser Hammad, M.D.

- **Role:** SUB_INVESTIGATOR

**Country:** Qatar

**Facility:** ACC, Hamad Medical Corporation

**State:** Doah

**Status:** RECRUITING

**Zip:** 3050

#### Overall Officials

**Official 1:**

**Affiliation:** Hamad Medical Corporation - HMC

**Name:** Nabil Shallik, M.D.

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**Access Criteria:** Through Website

**Description:** We will share after IRB approval

**Info Types:**

- STUDY_PROTOCOL

- SAP

- ICF

**IPD Sharing:** YES

**Time Frame:** After approval IRB directly

### References Module

#### References

**Citation:** Butler PJ, Dhara SS. Prediction of difficult laryngoscopy: an assessment of the thyromental distance and Mallampati predictive tests. Anaesth Intensive Care. 1992 May;20(2):139-42. doi: 10.1177/0310057X9202000202.

**PMID:** 1595845

**Citation:** Janssens M, Hartstein G. Management of difficult intubation. Eur J Anaesthesiol. 2001 Jan;18(1):3-12. doi: 10.1046/j.0265-0215.2000.00777.x.

**PMID:** 11270007

**Citation:** Qudaisat IY, Al-Ghanem SM. Short thyromental distance is a surrogate for inadequate head extension, rather than small submandibular space, when indicating possible difficult direct laryngoscopy. Eur J Anaesthesiol. 2011 Aug;28(8):600-6. doi: 10.1097/EJA.0b013e328347cdd9.

**PMID:** 21610502

**Citation:** Langeron O, Masso E, Huraux C, Guggiari M, Bianchi A, Coriat P, Riou B. Prediction of difficult mask ventilation. Anesthesiology. 2000 May;92(5):1229-36. doi: 10.1097/00000542-200005000-00009.

**PMID:** 10781266

**Citation:** Tremblay MH, Williams S, Robitaille A, Drolet P. Poor visualization during direct laryngoscopy and high upper lip bite test score are predictors of difficult intubation with the GlideScope videolaryngoscope. Anesth Analg. 2008 May;106(5):1495-500, table of contents. doi: 10.1213/ane.0b013e318168b38f.

**PMID:** 18420866

**Citation:** Samsoon GL, Young JR. Difficult tracheal intubation: a retrospective study. Anaesthesia. 1987 May;42(5):487-90. doi: 10.1111/j.1365-2044.1987.tb04039.x.

**PMID:** 3592174

**Citation:** Sun DA, Warriner CB, Parsons DG, Klein R, Umedaly HS, Moult M. The GlideScope Video Laryngoscope: randomized clinical trial in 200 patients. Br J Anaesth. 2005 Mar;94(3):381-4. doi: 10.1093/bja/aei041. Epub 2004 Nov 26.

**PMID:** 15567809

**Citation:** Lundstrom LH, Moller AM, Rosenstock C, Astrup G, Wetterslev J. High body mass index is a weak predictor for difficult and failed tracheal intubation: a cohort study of 91,332 consecutive patients scheduled for direct laryngoscopy registered in the Danish Anesthesia Database. Anesthesiology. 2009 Feb;110(2):266-74. doi: 10.1097/ALN.0b013e318194cac8.

**PMID:** 19194154

**Citation:** Heinrich S, Birkholz T, Ihmsen H, Irouschek A, Ackermann A, Schmidt J. Incidence and predictors of difficult laryngoscopy in 11,219 pediatric anesthesia procedures. Paediatr Anaesth. 2012 Aug;22(8):729-36. doi: 10.1111/j.1460-9592.2012.03813.x. Epub 2012 Feb 20.

**PMID:** 22340664

**Citation:** Collins JS, Lemmens HJ, Brodsky JB, Brock-Utne JG, Levitan RM. Laryngoscopy and morbid obesity: a comparison of the "sniff" and "ramped" positions. Obes Surg. 2004 Oct;14(9):1171-5. doi: 10.1381/0960892042386869.

**PMID:** 15527629

**Citation:** Brodsky JB, Lemmens HJ, Brock-Utne JG, Vierra M, Saidman LJ. Morbid obesity and tracheal intubation. Anesth Analg. 2002 Mar;94(3):732-6; table of contents. doi: 10.1097/00000539-200203000-00047.

**PMID:** 11867407

**Citation:** Wilson ME, Spiegelhalter D, Robertson JA, Lesser P. Predicting difficult intubation. Br J Anaesth. 1988 Aug;61(2):211-6. doi: 10.1093/bja/61.2.211.

**PMID:** 3415893

**Citation:** Vicini C, De Vito A, Benazzo M, Frassineti S, Campanini A, Frasconi P, Mira E. The nose oropharynx hypopharynx and larynx (NOHL) classification: a new system of diagnostic standardized examination for OSAHS patients. Eur Arch Otorhinolaryngol. 2012 Apr;269(4):1297-300. doi: 10.1007/s00405-012-1965-z. Epub 2012 Feb 19.

**PMID:** 22350494

**Citation:** Soares MC, Sallum AC, Goncalves MT, Haddad FL, Gregorio LC. Use of Muller's maneuver in the evaluation of patients with sleep apnea--literature review. Braz J Otorhinolaryngol. 2009 May-Jun;75(3):463-6. doi: 10.1016/S1808-8694(15)30667-4.

**PMID:** 19649500

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009765

- Term: Obesity

- ID: D000050177

- Term: Overweight

- ID: D000044343

- Term: Overnutrition

- ID: D000009748

- Term: Nutrition Disorders

- ID: D000001835

- Term: Body Weight

### Condition Browse Module - Browse Branches

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M12701

- Name: Obesity

- Relevance: LOW

- As Found: Unknown

- ID: M12702

- Name: Obesity, Morbid

- Relevance: HIGH

- As Found: Obesity, Morbid

- ID: M26186

- Name: Overweight

- Relevance: LOW

- As Found: Unknown

- ID: M25307

- Name: Overnutrition

- Relevance: LOW

- As Found: Unknown

- ID: M12684

- Name: Nutrition Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M5114

- Name: Body Weight

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000009767

- Term: Obesity, Morbid

### Misc Info Module

- Version Holder: 2024-05-24
