Comprehensive Preoperative Airway Grading

Anesthesia Intubation Complication Clinical Trial

Official title:

Comprehensive Preoperative Airway Grading

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04864106
• Other study ID #: IRB-300004915
• Status: Recruiting
• Phase: N/A
• Start date: November 6, 2022
• Est. completion date: January 15, 2025

Study information

• Verified date: March 2024
• Source: University of Alabama at Birmingham
• Contact: Shanna Graves
• Phone: 205-975-2845
• Email: shannagraves[@]uabmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: January 15, 2025
• Est. primary completion date: December 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia Intubation Complication

Intervention

Device:
• Endoscopic Examination
Endoscopic airway grading using a rigid 75-degree angle laryngoscope.

Locations

Country	Name	City	State
United States	Shanna Graves	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participants comparison of grading scores on the traditional procedure verses the comprehensive airway grading	Cormack-Lehane system- Grading I-IV looking at the Vocal Cords and Epiglottis (1 is less restricted visibility, 4 is most restricted visibility)	Preoperatively