Evaluation of Preoperative Nasoendoscopy to Predict Difficult Intubation

Obesity, Morbid Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05043779
• Other study ID #: MRC-01-19-107
• Status: Recruiting
• Phase: N/A
• Start date: August 12, 2020
• Est. completion date: March 1, 2022

Study information

• Verified date: July 2021
• Source: Hamad Medical Corporation
• Contact: nabil Shallik, M.D.
• Phone: 9745543926
• Email: nshallik[@]hamad.qa
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 1, 2022
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Difficult or Failed Intubation
• Obesity, Morbid

Intervention

Procedure:
• Awake Airway Nasoendoscopy
Preoperative Awake Airway Nasoendoscopy of upper airway

Locations

Country	Name	City	State
Qatar	ACC, Hamad Medical Corporation	Doha	Doah

Sponsors (1)

Lead Sponsor	Collaborator
Hamad Medical Corporation

Country where clinical trial is conducted

Qatar, 

References & Publications (14)

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. — View 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. — View 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. — View 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 — View Citation

Janssens M, Hartstein G. Management of difficult intubation. Eur J Anaesthesiol. 2001 Jan;18(1):3-12. Review. — View 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. — View Citation

Lundstrøm LH, Møller 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 — View 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.0 — View Citation

Samsoon GL, Young JR. Difficult tracheal intubation: a retrospective study. Anaesthesia. 1987 May;42(5):487-90. — View Citation

Soares MC, Sallum AC, Gonçalves MT, Haddad FL, Gregório 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. Review. English, Portuguese. — View 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. Epub 2004 Nov 26. — View 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 o — View 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;26 — View Citation

Wilson ME, Spiegelhalter D, Robertson JA, Lesser P. Predicting difficult intubation. Br J Anaesth. 1988 Aug;61(2):211-6. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Measurement of neck circumference in Centimeter	This will be measured by centimeter during pre-operative assessment using a ruler	During pre-operative assessment.
Secondary	Mouth opening measurement by Centimeter	This will be measured by centimeter between incisors during pre-operative assessment using a ruler and documented by Centimeter	During pre-operative assessment.
Secondary	Thyro-mental distance measurement by Centimeter	This will be measured by centimeter from thyroid cartilage to patient's chin during pre-operative assessment using a rule	During pre-operative assessment.
Secondary	Difficult mask ventilation score (1 -3)	Degree of Difficulty in mask ventilation will be graded (1= easy, 2= difficult or 3=impossible) during induction of general anaesthesia	During Induction of anesthesia
Secondary	Cormak-Lehans grade during induction of anaesthesia	Cormak-Lehans Score will graded during endotracheal intubation and exposure of the larynx. (Grade 1= easy intubation while grade Grade 4= very difficult intubation)	During intubation