- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00874016
Airtraq Versus Standard Direct Laryngoscopy in the Pediatric Airway
December 15, 2010 updated by: IWK Health Centre
A Comparison of the Airtraq and Standard Direct Laryngoscopy in the Pediatric Airway - A Randomized Trial.
Time to intubate, view to glottic opening and success rate are not different when Airtraq technique is used compared to standard direct laryngoscopy in children.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
50 children (age 5 years and 11 month or younger) with expected easy intubation, scheduled for elective surgery requiring endotracheal intubation are enrolled.
Study Type
Interventional
Enrollment (Actual)
50
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
-
-
Nova Scotia
-
Halifax, Nova Scotia, Canada, B3K 6R8
- Department of Pediatric Anesthesia, IWK Health Centre
-
-
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
No older than 6 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- elective surgery requiring endotracheal intubation
Exclusion Criteria:
- predicted difficult bag-mask ventilation
- predicted difficult intubation
- rapid sequence induction
- emergency endotracheal intubation
- hemodynamic instability
- emergency surgery
- non-english speaking caregivers/parents
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: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Airtraq
Intubation with the use of the Airtraq
|
Intubation using Airtraq
|
|
Active Comparator: Direct Laryngoscopy
Intubation using direct laryngoscopy
|
Intubation using direct laryngoscopy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Time to intubation
Time Frame: 1 day
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Percentage of glottic opening seen
Time Frame: 1 day
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Arnim Vlatten, MD, IWK Health Centre
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.
General Publications
- Maharaj CH, O'Croinin D, Curley G, Harte BH, Laffey JG. A comparison of tracheal intubation using the Airtraq or the Macintosh laryngoscope in routine airway management: A randomised, controlled clinical trial. Anaesthesia. 2006 Nov;61(11):1093-9. doi: 10.1111/j.1365-2044.2006.04819.x.
- Maharaj CH, Costello JF, Harte BH, Laffey JG. Evaluation of the Airtraq and Macintosh laryngoscopes in patients at increased risk for difficult tracheal intubation. Anaesthesia. 2008 Feb;63(2):182-8. doi: 10.1111/j.1365-2044.2007.05316.x.
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
April 1, 2009
Primary Completion (Actual)
August 1, 2009
Study Completion (Actual)
December 1, 2009
Study Registration Dates
First Submitted
April 1, 2009
First Submitted That Met QC Criteria
April 1, 2009
First Posted (Estimate)
April 2, 2009
Study Record Updates
Last Update Posted (Estimate)
December 16, 2010
Last Update Submitted That Met QC Criteria
December 15, 2010
Last Verified
April 1, 2009
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Airtraq 4469
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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