NCT01564082

Brief Summary

Patients presenting for elective surgery will be randomized to having the breathing tube inserted partly into the throat prior to GlideScope insertion, or having it inserted fully after GlideScope insertion.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2012

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

March 6, 2012

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 27, 2012

Completed
5 days until next milestone

Study Start

First participant enrolled

April 1, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

April 10, 2015

Status Verified

April 1, 2015

Enrollment Period

11 months

First QC Date

March 6, 2012

Last Update Submit

April 9, 2015

Conditions

Endotracheal Intubation

Keywords

endotracheal intubationGlideScope

Outcome Measures

Primary Outcomes (1)

  • Time to Intubation

    Duration of intubation of the patient

    Day 1

Secondary Outcomes (4)

  • Ease of intubation

    Day 1

  • Number of intubation attempts

    Day 1

  • Use of external laryngeal pressure

    Day 1

  • Sore throat

    Day 3

Study Arms (2)

ETT first

EXPERIMENTAL

Patients will have the endotracheal tube (ETT) introduced into the pharynx prior to GlideScope insertion, and then advanced under GlideScope guidance into the trachea.

Device: ETT First (GlideScope)

Control Group

NO INTERVENTION

Patients will have the GlideScope introduced into the pharynx. The endotracheal tube (ETT) will then be advanced under direct vision into the mouth/pharynx. The ETT will then be advanced into the trachea under GlideScope guidance.

Interventions

ETT First (GlideScope)DEVICE

Patients will have the endotracheal tube (ETT) introduced into the pharynx under direct vision prior to GlideScope insertion. The ETT will then be advanced under GlideScope guidance into the trachea.

ETT first

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Any adult patient booked for elective surgery requiring orotracheal intubation.
  • Any operator who has performed ≥ 20 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.
  • 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

London, Ontario, N6A5A5, Canada

Location

Study Officials

  • Timothy P Turkstra, MD, M. Eng.

    LHRI

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor and Staff Anesthesiologist

Study Record Dates

First Submitted

March 6, 2012

First Posted

March 27, 2012

Study Start

April 1, 2012

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

April 10, 2015

Record last verified: 2015-04

Locations

CA(2)