Comprehensive Preoperative Airway Grading

NCT ID: NCT04864106

Last Updated: 2025-06-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-06
• Study Completion Date: 2023-08-30

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).

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.

Conditions

Anesthesia Intubation Complication

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Study Group

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

Group Type: EXPERIMENTAL

Endoscopic Examination

Intervention Type: DEVICE

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

Interventions

Endoscopic Examination

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Michael Froelich

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael Froelich, MD, MS

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

Shanna Graves

Birmingham, Alabama, United States

Countries

United States

Other Identifiers

UAB

Identifier Type: OTHER

Identifier Source: secondary_id

IRB-300004915

Identifier Type: -

Identifier Source: org_study_id