Comprehensive Preoperative Airway Grading

Sponsor

University of Alabama at Birmingham (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04864106

Collaborator

(none)

200

Enrollment

Arm

4.4

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Purpose of study: To contrast and compare the Mallampatti test to a comprehensive airway grading test using a rigid 75-degree angle laryngoscope (CPAG) Study Hypothesis: The investigators hypothesize that the CPAG will have greater sensitivity and specificity for predicting difficulty laryngoscopy as compared to the Mallampati test.

The investigators plan to test this hypothesis by comparing the correlation of (a) airway Mallampati airway grading (predicted airway difficulty) versus (b) CPAG view grading and Cormack Laryngoscopy assessment (observed airway difficulty).

Condition or Disease	Intervention/Treatment	Phase
Anesthesia Intubation Complication	Device: Endoscopic Examination	N/A

Detailed Description

The purpose of this study is to evaluate a comprehensive preoperative airway examination using a 75-degree rigid laryngoscope. (It is important to note that this laryngoscope is routinely used in the speech pathology clinic where patients are not required to provide a written consent because of the limited and non-invasive nature of the examination) The investigators plan to accomplish this by grading a person's airway using a laryngoscopy view and obtain pictures to describe a person's supraglottic airway. The investigators will use these measures to assist the anesthesiologists of the day of surgery with the approach of securing the airway (traditional laryngoscopy versus video-assisted laryngoscopy versus fiberoptic-guided laryngoscopy).

The traditional test and parameters for the assessment of the airway are: The Mallampatti test, the Wilson airway assessment, evaluation of the atlantooccipital joint extension (neck mobility), the thyro-mental distance, the sterno-mental distance, mandibulo-hyoid distance, inter-incisor distance (mouth opening). Other investigators have proposed the use of radiographic assessment methods. These traditional tests are limited by the inability to visualize the posterior pharynx, tongue base, and glottis. Difficulty in intubation can be classified according to the view obtained during direct laryngoscopy into 4 grades. These four grades of laryngoscopic views were defined by Cormack and Lehane. At the present time, no single airway test can provide a high index of sensitivity and specificity for the prediction of a difficult airway. Therefore, it is common practice to use a combination of multiple tests and accept that there is still ambiguity when predicting airway challenges and the best approach to securing an airway.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

We are adding a direct laryngoscopy based airway examination to the routine patient examination. Investigators will have two (complementary) methods of a preoperative airway examination; (a) the traditional Malampati airway examination and (b) the new laryngoscopy based examination. Both airway examination methods will be correlated with the airway grading during the induction of anesthesia (Cormack airway grading). The correlation strength of these two preoperative airway assessment methods and the intraoperative Cormack airway grading will be compared.We are adding a direct laryngoscopy based airway examination to the routine patient examination. Investigators will have two (complementary) methods of a preoperative airway examination; (a) the traditional Malampati airway examination and (b) the new laryngoscopy based examination. Both airway examination methods will be correlated with the airway grading during the induction of anesthesia (Cormack airway grading). The correlation strength of these two preoperative airway assessment methods and the intraoperative Cormack airway grading will be compared.

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Comprehensive Preoperative Airway Grading

Anticipated Study Start Date :

Dec 3, 2022

Anticipated Primary Completion Date :

Jan 15, 2023

Anticipated Study Completion Date :

Apr 15, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Study Group Participants will undergo a endoscopic airway assessment in addition to the airway classification using the Mallampati score.	Device: Endoscopic Examination Endoscopic airway grading using a rigid 75-degree angle laryngoscope.

Arm

Intervention/Treatment

Experimental: Study Group

Participants will undergo a endoscopic airway assessment in addition to the airway classification using the Mallampati score.

Device: Endoscopic Examination

Endoscopic airway grading using a rigid 75-degree angle laryngoscope.

Outcome Measures

Primary Outcome Measures

Participants comparison of grading scores on the traditional procedure verses the comprehensive airway grading [Preoperatively]
Cormack-Lehane system- Grading I-IV looking at the Vocal Cords and Epiglottis (1 is less restricted visibility, 4 is most restricted visibility)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Male or Female
18+
ASA status 1-4

Exclusion Criteria:

<18
patients unwilling to do the comprehensive airway examination
patients unable to do the comprehensive airway examination

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Alabama at Birmingham

Investigators

Principal Investigator: Michael Froelich, MD, MS, University of Alabama at Birmingham

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Michael Froelich, Principal Investigator, University of Alabama at Birmingham

ClinicalTrials.gov Identifier:

NCT04864106

Other Study ID Numbers:

IRB-300004915

First Posted:

Apr 28, 2021

Last Update Posted:

Feb 8, 2022

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Michael Froelich, Principal Investigator, University of Alabama at Birmingham

Airway Grading

Study Results

No Results Posted as of Feb 8, 2022