Airtraq Versus Standard Direct Laryngoscopy in the Pediatric Airway

This study has been completed.
Sponsor:
Information provided by:
IWK Health Centre
ClinicalTrials.gov Identifier:
NCT00874016
First received: April 1, 2009
Last updated: December 15, 2010
Last verified: April 2009
  Purpose

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.


Condition Intervention
Endotracheal Intubation
Device: Airtraq
Device: Direct Laryngoscopy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Comparison of the Airtraq and Standard Direct Laryngoscopy in the Pediatric Airway - A Randomized Trial.

Further study details as provided by IWK Health Centre:

Primary Outcome Measures:
  • Time to intubation [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of glottic opening seen [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: April 2009
Study Completion Date: December 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Airtraq
Intubation with the use of the Airtraq
Device: Airtraq
Intubation using Airtraq
Active Comparator: Direct Laryngoscopy
Intubation using direct laryngoscopy
Device: Direct Laryngoscopy
Intubation using direct laryngoscopy

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.

  Eligibility

Ages Eligible for Study:   up to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  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: NCT00874016

Locations
Canada, Nova Scotia
Department of Pediatric Anesthesia, IWK Health Centre
Halifax, Nova Scotia, Canada, B3K 6R8
Sponsors and Collaborators
IWK Health Centre
Investigators
Principal Investigator: Arnim Vlatten, MD IWK Health Centre
  More Information

Publications:
Responsible Party: Arnim Vlatten, MD, Department of Pediatric Anesthesia, IWK Health Centre
ClinicalTrials.gov Identifier: NCT00874016     History of Changes
Other Study ID Numbers: Airtraq 4469
Study First Received: April 1, 2009
Last Updated: December 15, 2010
Health Authority: Canada: Health Canada

Keywords provided by IWK Health Centre:
intubation
Airtraq
pediatric
airway

ClinicalTrials.gov processed this record on July 23, 2014