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Airtraq Versus Standard Direct Laryngoscopy in the Pediatric Airway

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ClinicalTrials.gov Identifier: NCT00874016
Recruitment Status : Completed
First Posted : April 2, 2009
Last Update Posted : December 16, 2010
Sponsor:
Information provided by:
IWK Health Centre

Tracking Information
First Submitted Date  ICMJE April 1, 2009
First Posted Date  ICMJE April 2, 2009
Last Update Posted Date December 16, 2010
Study Start Date  ICMJE April 2009
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 1, 2009)
Time to intubation [ Time Frame: 1 day ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00874016 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 1, 2009)
Percentage of glottic opening seen [ Time Frame: 1 day ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Airtraq Versus Standard Direct Laryngoscopy in the Pediatric Airway
Official Title  ICMJE A Comparison of the Airtraq and Standard Direct Laryngoscopy in the Pediatric Airway - A Randomized Trial.
Brief 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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Endotracheal Intubation
Intervention  ICMJE
  • Device: Airtraq
    Intubation using Airtraq
  • Device: Direct Laryngoscopy
    Intubation using direct laryngoscopy
Study Arms  ICMJE
  • Active Comparator: Airtraq
    Intubation with the use of the Airtraq
    Intervention: Device: Airtraq
  • Active Comparator: Direct Laryngoscopy
    Intubation using direct laryngoscopy
    Intervention: Device: Direct Laryngoscopy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 1, 2009)
50
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2009
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 6 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00874016
Other Study ID Numbers  ICMJE Airtraq 4469
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Arnim Vlatten, MD, Department of Pediatric Anesthesia, IWK Health Centre
Study Sponsor  ICMJE IWK Health Centre
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Arnim Vlatten, MD IWK Health Centre
PRS Account IWK Health Centre
Verification Date April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP