NCT01793727

Brief Summary

A prospective trial evaluating the learning curve associated with the use of a videolaryngoscope compared to conventional direct laryngoscopy in infants intubated by anesthesiology residents. Hypothesis: The learning curves of both instruments are equivalent.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2011

Geographic Reach
1 country

1 active site

Status
withdrawn

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

July 1, 2011

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 12, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 15, 2013

Completed
Last Updated

April 18, 2018

Status Verified

April 1, 2018

Enrollment Period

11 months

First QC Date

February 12, 2013

Last Update Submit

April 16, 2018

Conditions

Tracheal Intubation

Keywords

infantsgeneral anesthesiatracheal intubation

Outcome Measures

Primary Outcomes (1)

  • Time to optimum visualization of the vocal cords

    Under 2 minutes

Secondary Outcomes (1)

  • Time to tracheal intubation

    Under 2 minutes

Study Arms (1)

Glidescope intubation

EXPERIMENTAL

Comparison of direct laryngoscopy and Glidescope videolaryngoscopy

Device: Glidescope videolaryngoscope

Interventions

Glidescope videolaryngoscopeDEVICE
Glidescope intubation

Eligibility Criteria

AgeUp to 18 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • infants under 10 kg undergoing general anesthesia and requiring tracheal intubation

You may not qualify if:

  • Difficult airway, severe cardiorespiratory disease, emergency surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Study Officials

  • Cengiz Karsli, MD

    The Hospital for Sick Children

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Primary Investigator

Study Record Dates

First Submitted

February 12, 2013

First Posted

February 15, 2013

Study Start

July 1, 2011

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

April 18, 2018

Record last verified: 2018-04

Locations

CA(1)