NCT00459797

Brief Summary

Patients presenting for elective surgery requiring orotracheal intubation will be randomized to being intubated with either the conventional (reusable) GlideScope videolaryngoscope or the single-use GlideScope videolaryngoscope. The primary outcome is time to intubation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Apr 2007

Typical duration for not_applicable healthy

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

April 1, 2007

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

April 12, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 13, 2007

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

April 21, 2009

Status Verified

April 1, 2009

Enrollment Period

1.3 years

First QC Date

April 12, 2007

Last Update Submit

April 20, 2009

Conditions

Healthy

Keywords

GlideScopecobaltsingle-useintubationairwayElective surgical patients requiring orotracheal intubation

Outcome Measures

Primary Outcomes (1)

  • Time to intubation (seconds)

    Immediate

Secondary Outcomes (6)

  • Ease of intubation

    after intubation

  • Number of intubation attempts per group

    after intubation

  • Incidence of trauma in each group

    after intubation

  • Number of failures to intubate per group

    after intubation

  • Use of external laryngeal pressure per group

    after intubation

  • +1 more secondary outcomes

Study Arms (2)

Conventional Glidescope

ACTIVE COMPARATOR
Device: Conventional (reusable) Glidescope

Single-use Glidescope

EXPERIMENTAL
Device: Single-use Glidescope videolaryngoscope

Interventions

Conventional (reusable) GlidescopeDEVICE
Conventional Glidescope
Single-use Glidescope videolaryngoscopeDEVICE
Single-use Glidescope

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Any patient who is ≥ 18 yrs. coming for elective surgery.
  • Endotracheal tube is indicated for the procedure in the opinion of the attending anesthesiologist.
  • Any operator who has performed ≥ 10 GlideScope intubations.

You may not qualify if:

  • Any patient in whom the use of the GlideScope is contraindicated in the opinion of the attending anesthesiologist.
  • Any patient with cervical spine abnormalities.
  • Any patients with known or probable difficult airways (this rare occurrence is unlikely to be evenly distributed between the groups and could skew the data).
  • Any patient requiring rapid sequence induction.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

London Health Sciences Centre

London, Ontario, N6A5A5, Canada

Location

Related Publications (1)

  • Jones PM, Turkstra TP, Armstrong KP, Armstrong PM, Harle CC. Comparison of a single-use GlideScope Cobalt videolaryngoscope with a conventional GlideScope for orotracheal intubation. Can J Anaesth. 2010 Jan;57(1):18-23. doi: 10.1007/s12630-009-9204-9. Epub 2009 Oct 31.

    PMID: 19882199DERIVED

Study Officials

  • Philip M Jones, MD

    London Health Sciences Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 12, 2007

First Posted

April 13, 2007

Study Start

April 1, 2007

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

April 21, 2009

Record last verified: 2009-04

Locations

CA(1)