Evaluation of Preoperative Nasoendoscopy to Predict Difficult Intubation

September 5, 2021 updated by: Hamad Medical Corporation

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Qatar
    • Doah
      • Doha, Doah, Qatar, 3050
        • Recruiting
        • ACC, Hamad Medical Corporation
        • Contact:
        • Principal Investigator:
          • Mohamed A. Elarref, M.D.
        • Sub-Investigator:
          • Mayed Radi, M.D.
        • Principal Investigator:
          • Olfa Al Mannai, M.D.
        • Sub-Investigator:
          • Adnan Saad Eddin, MBBcH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Preoperative Awake Airway Nasoendoscopy
only one arm
Procedure: Awake Airway Nasoendoscopy
Preoperative Awake Airway Nasoendoscopy of upper airway

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Naso-endoscopy views from nose to larynx in obese patients using NOHL score during pre-operative assessment.
Time Frame: 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of neck circumference in Centimeter
Time Frame: During pre-operative assessment.
This will be measured by centimeter during pre-operative assessment using a ruler
During pre-operative assessment.
Mouth opening measurement by Centimeter
Time Frame: During pre-operative assessment.
This will be measured by centimeter between incisors during pre-operative assessment using a ruler and documented by Centimeter
During pre-operative assessment.
Thyro-mental distance measurement by Centimeter
Time Frame: During pre-operative assessment.
This will be measured by centimeter from thyroid cartilage to patient's chin during pre-operative assessment using a rule
During pre-operative assessment.
Difficult mask ventilation score (1 -3)
Time Frame: During Induction of anesthesia
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
Cormak-Lehans grade during induction of anaesthesia
Time Frame: During intubation
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hamad Medical Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 12, 2020

Primary Completion (Anticipated)

March 1, 2022

Study Completion (Anticipated)

March 1, 2022

Study Registration Dates

First Submitted

July 28, 2021

First Submitted That Met QC Criteria

September 5, 2021

First Posted (Actual)

September 14, 2021

Study Record Updates

Last Update Posted (Actual)

September 14, 2021

Last Update Submitted That Met QC Criteria

September 5, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MRC-01-19-107

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

We will share after IRB approval

IPD Sharing Time Frame

After approval IRB directly

IPD Sharing Access Criteria

Through Website

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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