Comprehensive Preoperative Airway Grading

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).

Study Overview

• Status: Completed
• Conditions: Anesthesia Intubation Complication
• Intervention / Treatment: Device: Endoscopic Examination

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 Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35578
      • Shanna Graves

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2022
• Primary Completion (Actual): August 30, 2023
• Study Completion (Actual): August 30, 2023

Study Registration Dates

• First Submitted: November 5, 2020
• First Submitted That Met QC Criteria: April 26, 2021
• First Posted (Actual): April 28, 2021

Study Record Updates

• Last Update Posted (Actual): June 13, 2025
• Last Update Submitted That Met QC Criteria: June 10, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Airway Grading
• Other Study ID Numbers: IRB-300004915; UAB (Other Identifier: UAB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: To be determined.

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