NCT00874016

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2009

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 1, 2009

Completed
Same day until next milestone

Study Start

First participant enrolled

April 1, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 2, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

December 16, 2010

Status Verified

April 1, 2009

Enrollment Period

4 months

First QC Date

April 1, 2009

Last Update Submit

December 15, 2010

Conditions

Endotracheal Intubation

Keywords

intubationAirtraqpediatricairway

Outcome Measures

Primary Outcomes (1)

  • Time to intubation

    1 day

Secondary Outcomes (1)

  • Percentage of glottic opening seen

    1 day

Study Arms (2)

Airtraq

ACTIVE COMPARATOR

Intubation with the use of the Airtraq

Device: Airtraq

Direct Laryngoscopy

ACTIVE COMPARATOR

Intubation using direct laryngoscopy

Device: Direct Laryngoscopy

Interventions

AirtraqDEVICE

Intubation using Airtraq

Airtraq
Direct LaryngoscopyDEVICE

Intubation using direct laryngoscopy

Direct Laryngoscopy

Eligibility Criteria

AgeUp to 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • elective surgery requiring endotracheal intubation

You may not qualify if:

  • predicted difficult bag-mask ventilation
  • predicted difficult intubation
  • rapid sequence induction
  • emergency endotracheal intubation
  • hemodynamic instability
  • emergency surgery
  • non-english speaking caregivers/parents

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Pediatric Anesthesia, IWK Health Centre

Halifax, Nova Scotia, B3K 6R8, Canada

Location

Related 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.

    PMID: 18211450BACKGROUND

  • 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.

    PMID: 17042849BACKGROUND

Study Officials

  • Arnim Vlatten, MD

    IWK Health Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 1, 2009

First Posted

April 2, 2009

Study Start

April 1, 2009

Primary Completion

August 1, 2009

Study Completion

December 1, 2009

Last Updated

December 16, 2010

Record last verified: 2009-04

Locations

CA(1)