Anticipation of the Difficult Airway: the Preoperative Airway Assessment Form

September 23, 2014 updated by: Carin A. Hagberg, The University of Texas Health Science Center, Houston

Anticipation of the Difficult Airway: the Preoperative Airway Assessment Form as an Educational and Quality Improvement Tool

The purpose of this study is to see if our experimental preoperative airway assessment form is a better indicator of difficult airway as compared to the anesthesia record that is presently used.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

Predicting difficult airway continues to be problematic for even the most seasoned of anesthesiologists. In our study, the resident class will be our sample population. The residents will be randomly assigned into two groups: the experimental group will be utilizing the new preoperative airway assessment form and the control group will be utilizing the standard anesthesia record. Simultaneously, a subset of our anesthesia experts will also be assessing patients preoperatively. The five areas of difficult airway management will be considered: difficult mask ventilation, difficult supraglottic airway, difficult laryngoscopy, difficult intubation, and difficult surgical airway.

According to the American Society of Anesthesiologists, the incidence of intubation has remained stable throughout the 1980s and 1990s despite attempts to predict its occurrence. Many of these cases were considered to be preventable; therefore, a better prediction of and preparation for difficult airway management may lead to a reduction in adverse events.

Study Type

Interventional

Enrollment (Actual)

89

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Texas
      • Houston, Texas, United States, 77030
        • Memorial Hermann Hospital, Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • CA-1, CA-2, and CA-3 anesthesiology residents starting from July 2008-July 2010

Exclusion Criteria:

  • the same anesthesiology residents who are working with patients 17 and younger, patients who are already intubated, and patients undergoing emergent surgery.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Difficult Airway Assessment Form
(based on the american society of anesthesiologists)components of the form include: neck measurements; neck mobility; mallampati; wilson's test; pre-existing conditions; and predictions of difficult mask ventilation, supraglottic airway, laryngoscopy, intubation, and surgical airway.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Use of an experimental preoperative assessment form by residents will result in more complete documentation of important airway features compared to use of the current forms
Time Frame: interim analysis will be assessed after 1 year
interim analysis will be assessed after 1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
use of the experimental preoperative assessment form will result in greater resident recognition of patients at high risk for a difficult airway as judged independently by one of 3 senior faculty investigators.
Time Frame: interim analyses will be assessed after 1 year
interim analyses will be assessed after 1 year
the percentage of patients intubated using an awake method will be greater among residents using the new form than those using the current form
Time Frame: interim analysis will be assessed after 1 year
interim analysis will be assessed after 1 year
the percentage of patients requiring multiple intubation attempts or use of invasive airway techniques will be lower among residents using the new form.
Time Frame: interim analysis will be assessed after 1 year
interim analysis will be assessed after 1 year
spontaneous knowledge of important airway features will be more complete among residents using the new form at 18 months of training.
Time Frame: interim analysis will be assessed after 1 year
interim analysis will be assessed after 1 year
observations made during this study will allow refinement of the new form to augment the identification of patients with difficult airway.
Time Frame: interim analysis will be assessed after 1 year
interim analysis will be assessed after 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Carin A Hagberg, MD, University of Texas at Houston Health Science Center, Medical School

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

December 21, 2009

First Submitted That Met QC Criteria

December 21, 2009

First Posted (Estimate)

December 23, 2009

Study Record Updates

Last Update Posted (Estimate)

September 25, 2014

Last Update Submitted That Met QC Criteria

September 23, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • 07-0144

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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