Comprehensive Preoperative Airway Grading

NCT04864106 | Completed

• 2 other identifiers: IRB-300004915UAB
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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).

Conditions

Anesthesia Intubation Complication

Keywords

Airway Grading

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Study Group

EXPERIMENTAL

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

Device: Endoscopic Examination

Interventions

Endoscopic Examination DEVICE

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

Study Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or Female
• ASA status 1-4

You may not qualify if:

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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

Shanna Graves

Birmingham, Alabama, 35578, United States

Location

MeSH Terms

Interventions

Endoscopy

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Michael Froelich, MD, MS

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: November 5, 2020
• First Posted: April 28, 2021
• Study Start: November 6, 2022
• Primary Completion: August 30, 2023
• Study Completion: August 30, 2023
• Last Updated: June 13, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)