NCT01037374

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
89

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

December 21, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 23, 2009

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

September 25, 2014

Status Verified

September 1, 2014

Enrollment Period

4.3 years

First QC Date

December 21, 2009

Last Update Submit

September 23, 2014

Conditions

Keywords

riskassessmentdifficultendotrachealintubation

Outcome Measures

Primary Outcomes (1)

  • 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

    interim analysis will be assessed after 1 year

Secondary Outcomes (5)

  • 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.

    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

    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.

    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.

    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.

    interim analysis will be assessed after 1 year

Study Arms (1)

Difficult Airway Assessment Form

EXPERIMENTAL
Other: Preoperative assessment form

Interventions

(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.

Difficult Airway Assessment Form

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Hermann Hospital, Medical Center

Houston, Texas, 77030, United States

Location

Related Links

Study Officials

  • Carin A Hagberg, MD

    University of Texas at Houston Health Science Center, Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor - Anesthesiology

Study Record Dates

First Submitted

December 21, 2009

First Posted

December 23, 2009

Study Start

August 1, 2008

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

September 25, 2014

Record last verified: 2014-09

Locations