NCT01489605

Brief Summary

Patients presenting for elective surgery requiring orotracheal intubation will be randomized to being intubated with either the GlideScope Groove video-laryngoscope or the standard GlideScope video-laryngoscope.

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 2019

Geographic Reach
1 country

2 active sites

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withdrawn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

First Submitted

Initial submission to the registry

December 8, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 9, 2011

Completed
7.6 years until next milestone

Study Start

First participant enrolled

July 1, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

February 28, 2019

Status Verified

February 1, 2019

Enrollment Period

11 months

First QC Date

December 8, 2011

Last Update Submit

February 26, 2019

Conditions

Intubation, Orotracheal

Keywords

Orotracheal intubation, videolaryngoscopy

Outcome Measures

Primary Outcomes (1)

  • Duration of Intubation

    Duration of Intubation - Mask removal to ETCO2 confirmation

    Day 1

Secondary Outcomes (6)

  • Ease of intubation

    Day 1

  • Incidence of trauma

    Day 1

  • Number of failures to intubate

    Day 1

  • Use of external laryngeal pressure

    Day 1

  • Laryngoscopic grade distribution

    Day 1

  • +1 more secondary outcomes

Study Arms (2)

GlideScope Groove

EXPERIMENTAL

Patients will be intubated using the GlideScope Groove device. (Verathon)

Device: GlideScope Groove

Control: Standard GlideScope

ACTIVE COMPARATOR

Control: Patients will be intubated using standard practice, a standard GlideScope (Verathon)

Device: Control: Standard GlideScope

Interventions

GlideScope GrooveDEVICE

Patients will be intubated using the GlideScope Groove device. (Verathon)

Also known as: Verathon
GlideScope Groove
Control: Standard GlideScopeDEVICE

Patients will be intubated using the standard GlideScope. (Verathon)

Also known as: Varathon
Control: Standard GlideScope

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.

You may not qualify if:

  • 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)

London Health Sciences Center University Hospital

London, Ontario, N6A5A5, Canada

Location

London Health Sciences Centre Victoria Campus

London, Ontario, N6A5a5, Canada

Location

Study Officials

  • Timothy Turkstra, MD, M. Eng

    UWO

    PRINCIPAL INVESTIGATOR
0

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
Staff Anesthesiologist and Associate Professor

Study Record Dates

First Submitted

December 8, 2011

First Posted

December 9, 2011

Study Start

July 1, 2019

Primary Completion

June 1, 2020

Study Completion

June 1, 2020

Last Updated

February 28, 2019

Record last verified: 2019-02

Locations

CA(2)