Clinical trial NCT05043779: 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?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Difficult or Failed Intubation
Obesity, Morbid
Keywords: Nasoendoscopy,
Obesity,
Difficult intubation
Lead sponsor: Hamad Medical Corporation
Sponsor class: INDUSTRY
First posted: 2021-09-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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

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

Primary outcomes:
measure: Naso-endoscopy views from nose to larynx in obese patients using NOHL score during pre-operative assessment.
timeFrame: During pre-operative assessment.
Secondary outcomes:
measure: Measurement of neck circumference in Centimeter
timeFrame: During pre-operative assessment.
measure: Mouth opening measurement by Centimeter
timeFrame: During pre-operative assessment.
measure: Thyro-mental distance measurement by Centimeter
timeFrame: During pre-operative assessment.
measure: Difficult mask ventilation score (1 -3)
timeFrame: During Induction of anesthesia
measure: Cormak-Lehans grade during induction of anaesthesia
timeFrame: During intubation
Other outcomes:
Locations:
city: Doha
country: Qatar
facility: ACC, Hamad Medical Corporation
state: Doah
Study officials:
affiliation: Hamad Medical Corporation - HMC
name: Nabil Shallik, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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