NCT01215422

Brief Summary

There are two new instruments on the market that anesthesiologists use when putting a breathing tube into the lungs of patients. The purpose of this study is to see how easily anesthesiologists can learn to use them in children.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
646

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2007

Longer than P75 for all trials

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

Study Start

First participant enrolled

January 1, 2007

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

October 4, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 6, 2010

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

October 8, 2012

Completed
Last Updated

October 8, 2012

Status Verified

October 1, 2012

Enrollment Period

4.5 years

First QC Date

October 4, 2010

Results QC Date

February 3, 2012

Last Update Submit

October 5, 2012

Conditions

Keywords

Surgical proceduresIntubationAnesthesiologistLaryngoscopeVideolaryngoscope

Outcome Measures

Primary Outcomes (1)

  • Success in Learning to Use a Videolaryngoscope(VLS)

    Anesthesiologists were to perform 20 intubations with each videolaryngoscopes. #1-10 were for practice. "Rapid Success" was no failed intubation attempts on #11-20 and a median time-to-intubation no more than 50% longer than their baseline median time-to-intubation on #11-15 . "Delayed Success" was achieving these same parameters on #16-20 if they were not achieved on #11-15. Operators who did not achieve either goal were labeled as having "No Success".

    Up to 5 minutes per intubation

Secondary Outcomes (5)

  • Cormack & Lehane Score

    reported during intubation (up to 5 minutes)

  • Time to Intubation, Analyzed by Order of Laryngoscopes Used

    4 years

  • Time to Intubation, Stratified by Weight of Patients

    4 years

  • Mean Years Since Completion of Anesthesiology Residency

    Baseline (assessed as of 2008)

  • Number of Intubation Attempts to Reach "Best Obtainable Time to Intubation"

    less than 5 minutes per intubation

Study Arms (2)

children intubated with Glidescope

children intubated with Glidescope

Procedure: timed intubation

children intubated with DCI

children intubated with DCI

Procedure: timed intubation

Interventions

timed intubation

children intubated with DCIchildren intubated with Glidescope

Eligibility Criteria

AgeUp to 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children being intubated for surgery

You may qualify if:

  • \- Children requiring intubation for elective or non-elective surgery

You may not qualify if:

  • Children with raised intracranial pressure
  • Children with potential cervical spine injuries
  • Children at risk for regurgitation because of a full stomach
  • Children who were anticipated to have a difficult airway based on their physical appearance or previous experience were excluded.
  • \*Anesthesiologists who care for children at Stollery Children's Hospital
  • \*None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stollery Children's Hospital

Edmonton, Alberta, T6G 2J3, Canada

Location

Limitations and Caveats

Level of success could only be determined for the 8 anesthesiologists who completed minimum 18 intubations with the GS or KS video laryngoscope. Only 6 of 14 completed the whole study so had data could be used in comparing the two scopes.

Results Point of Contact

Title
DR. JOAN ROBINSON
Organization
UNIVERSITY OF ALBERTA

Study Officials

  • Joan L Robinson, MD

    University of Alberta

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physician

Study Record Dates

First Submitted

October 4, 2010

First Posted

October 6, 2010

Study Start

January 1, 2007

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

October 8, 2012

Results First Posted

October 8, 2012

Record last verified: 2012-10

Locations