Anticipation of the Difficult Airway: the Preoperative Airway Assessment Form

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by The University of Texas Health Science Center, Houston.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Foundation for Anesthesia Education and Research
Information provided by:
The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT01037374
First received: December 21, 2009
Last updated: January 5, 2011
Last verified: January 2011
  Purpose

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.


Condition Intervention
Endotracheal Intubation Risk Assessment
Other: Preoperative assessment form

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Anticipation of the Difficult Airway: the Preoperative Airway Assessment Form as an Educational and Quality Improvement Tool

Further study details as provided by The University of Texas Health Science Center, Houston:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 89
Study Start Date: August 2008
Estimated Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Difficult Airway Assessment Form Other: Preoperative 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01037374

Locations
United States, Texas
Memorial Hermann Hospital, Medical Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Foundation for Anesthesia Education and Research
Investigators
Principal Investigator: Carin A Hagberg, MD University of Texas at Houston Health Science Center, Medical School
  More Information

Additional Information:
No publications provided

Responsible Party: Carin Hagberg, University of Texas at Houston Medical school
ClinicalTrials.gov Identifier: NCT01037374     History of Changes
Other Study ID Numbers: 07-0144
Study First Received: December 21, 2009
Last Updated: January 5, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by The University of Texas Health Science Center, Houston:
risk
assessment
difficult
endotracheal
intubation

ClinicalTrials.gov processed this record on July 24, 2014