Evaluation of Preoperative Nasoendoscopy to Predict Difficult Intubation

NCT05043779 | Unknown

• 1 other identifier: MRC-01-19-107
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Difficult or Failed Intubation; Obesity, Morbid

Keywords

Nasoendoscopy,; Obesity,; Difficult intubation

Outcome Measures

Primary Outcomes (1)

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

  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)

  During pre-operative assessment.

Secondary Outcomes (5)

• Measurement of neck circumference in Centimeter

  During pre-operative assessment.

• Mouth opening measurement by Centimeter

  During pre-operative assessment.

• Thyro-mental distance measurement by Centimeter

  During pre-operative assessment.

• Difficult mask ventilation score (1 -3)

  During Induction of anesthesia

• Cormak-Lehans grade during induction of anaesthesia

  During intubation

Study Arms (1)

Preoperative Awake Airway Nasoendoscopy

OTHER

only one arm

Procedure: Awake Airway Nasoendoscopy

Interventions

Awake Airway Nasoendoscopy PROCEDURE

Preoperative Awake Airway Nasoendoscopy of upper airway

Preoperative Awake Airway Nasoendoscopy

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Hamad Medical Corporation: lead

Study Sites (1)

ACC, Hamad Medical Corporation

Doha, Doah, 3050, Qatar

RECRUITING

Related Publications (14)

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

MeSH Terms

Conditions

Obesity, Morbid; Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Nabil Shallik, M.D.

  Hamad Medical Corporation - HMC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

nabil Shallik, M.D.

CONTACT

9745543926; nshallik@hamad.qa

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2021
• First Posted: September 14, 2021
• Study Start: August 12, 2020
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2022
• Last Updated: September 14, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: After approval IRB directly
• Access Criteria: Through Website

Locations

QA (1)