- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01037374
Anticipation of the Difficult Airway: the Preoperative Airway Assessment Form
Anticipation of the Difficult Airway: the Preoperative Airway Assessment Form as an Educational and Quality Improvement Tool
Study Overview
Status
Conditions
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- Memorial Hermann Hospital, Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Collaborators
Investigators
- Principal Investigator: Carin A Hagberg, MD, University of Texas at Houston Health Science Center, Medical School
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
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.
Clinical Trials on Endotracheal Intubation Risk Assessment
-
Aswan UniversityCompletedEndotracheal Intubation Using Videolaryngoscope for General Anesthesia | Endotracheal Intubation Risk AssessmentEgypt
-
Kocaeli City HospitalNot yet recruitingVideolaryngoscopy | Awake Fiberoptic Nasal Intubation | Awake Endotracheal Intubation | Airway Management Assessment | Supraglottic Airway Device InsertionTurkey (Türkiye)
-
The Catholic University of KoreaCompletedEndotracheal Intubation | Individualized Depth of Endotracheal IntubationKorea, Republic of
-
University Hospital, Clermont-FerrandSociété Française d'Anesthésie-Réanimation (SFAR)CompletedEndotracheal Intubation | Intubation Complication | Intubation; Difficult or FailedFrance
-
Wuerzburg University HospitalUniversity Hospital, Bonn; University Hospital, AachenCompletedEndotracheal IntubationGermany
-
Cukurova UniversityCompletedEndotracheal IntubationTurkey
-
Mahidol UniversityCompletedIntubation, EndotrachealThailand
-
Ain Shams UniversityUnknown
-
Manuel Ángel Gómez-RíosCompletedEndotracheal IntubationSpain
Clinical Trials on Preoperative assessment form
-
Ottawa Hospital Research InstituteCompletedMortality | Aged | Epidemiology | SURGICAL PROCEDURES, OPERATIVECanada
-
Seoul National University HospitalNot yet recruitingPostoperative Complications | Major Noncardiac Surgery | Geriatric AnesthesiaSouth Korea
-
Maastricht University Medical CenterZuyderland Medical Centre; Annadal ClinicTerminatedArthroplasty, Replacement, KneeNetherlands
-
University of Eastern FinlandKuopio University HospitalCompletedHip Arthrosis | Multimorbidity | Knee ArthrosisFinland
-
Ankara Ataturk Sanatorium Training and Research...RecruitingPostoperative Complications | Lung Cancer | Nutrition, HealthyTurkey
-
Hospices Civils de LyonNot yet recruitingFertility | Oncofertility | Male CancerFrance
-
Diskapi Yildirim Beyazit Education and Research...RecruitingPediatric Anesthesia | Difficult LaryngoscopyTurkey (Türkiye)
-
Istinye UniversityNot yet recruiting
-
Diakonessenhuis, UtrechtCompleted
-
Landspitali University HospitalCompletedPostoperative Complications | Surgical Site Infection | Risk Reduction | Total Joint Arthroplasty | Prosthetic-joint InfectionIceland