NCT02787629

Brief Summary

Patients presenting for elective surgery requiring orotracheal intubation will be randomized to having the ETT inserted into the pharynx simultaneous to GlideScope insertion and then having the ETT advanced under GlideScope guidance into the trachea, or, being intubated in the more common fashion with the GlideScope being inserted first and having the ETT then advanced via the pharynx into the trachea.

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 Oct 2016

Geographic Reach
1 country

2 active sites

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

May 25, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 1, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
Last Updated

March 1, 2019

Status Verified

February 1, 2019

Enrollment Period

1.7 years

First QC Date

May 25, 2016

Last Update Submit

February 27, 2019

Conditions

Keywords

D007440

Outcome Measures

Primary Outcomes (1)

  • Duration of Intubation

    Duration of Intubation from mask removal to confirmation of ETCO2

    During the intubation

Secondary Outcomes (5)

  • Ease of Intubation

    Within 5 minutes of the completion of the intubation

  • Number of intubation attempts

    Within 5 minutes of the completion of the intubation

  • Failure to intubate

    Within 5 minutes of the completion of the intubation

  • Laryngoscopic Grade

    Within 5 minutes of the completion of the intubation

  • Oropharyngeal Trauma

    Within 5 minutes of the completion of the intubation

Study Arms (2)

Simultaneous

EXPERIMENTAL

Simultaneous Intubation with GlideScope and ETT inserted simultaneously

Procedure: Simultaneous Intubation

Control Standard

ACTIVE COMPARATOR

Standard Intubation with GlideScope inserted first and ETT inserted after the GlideScope view is obtained

Procedure: Standard Intubation

Interventions

Intubation with GlideScope and ETT inserted simultaneously

Simultaneous

Intubation with GlideScope inserted first and ETT insertion after the GlideScope view is obtained

Control Standard

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \) Adult patient booked for elective surgery requiring orotracheal intubation

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.
  • Any patient requiring rapid sequence induction.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

St. Joseph's Health Care

London, Ontario, N6A 4V2, Canada

Location

London Health Sciences Center University Hospital

London, Ontario, N6A5A5, Canada

Location

Related Publications (1)

  • Turkstra TP, Turkstra DC, Pavlosky AW, Jones PM. Simultaneous en bloc endotracheal tube insertion with GlideScope(R) Titanium video laryngoscope use: a randomized-controlled trial. Can J Anaesth. 2020 Nov;67(11):1515-1523. doi: 10.1007/s12630-020-01778-2. Epub 2020 Aug 19.

Study Officials

  • Timothy Turkstra

    University of Western Ontario, Canada

    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
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2016

First Posted

June 1, 2016

Study Start

October 1, 2016

Primary Completion

June 30, 2018

Study Completion

June 30, 2018

Last Updated

March 1, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations