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NCT00874016 Clinical Trial

Airtraq Versus Standard Direct Laryngoscopy in the Pediatric Airway

Endotracheal Intubation Clinical Trial

Official title:
A Comparison of the Airtraq and Standard Direct Laryngoscopy in the Pediatric Airway - A Randomized Trial.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00874016
Other study ID # Airtraq 4469
Secondary ID
Status Completed
Phase N/A
First received April 1, 2009
Last updated December 15, 2010
Start date April 2009
Est. completion date December 2009

Study information
Verified date April 2009
Source IWK Health Centre
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Interventional

Clinical Trial Summary

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.

Description:

50 children (age 5 years and 11 month or younger) with expected easy intubation, scheduled for elective surgery requiring endotracheal intubation are enrolled.

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date December 2009
Est. primary completion date August 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A to 6 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• Airtraq
Intubation using Airtraq
• Direct Laryngoscopy
Intubation using direct laryngoscopy

Locations
Country Name City State
Canada Department of Pediatric Anesthesia, IWK Health Centre Halifax Nova Scotia

Sponsors (1)
Lead Sponsor Collaborator
IWK Health Centre

Country where clinical trial is conducted

Canada, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Time to intubation 1 day No
Secondary Percentage of glottic opening seen 1 day No
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