GlideScope Groove vs. Standard GlideScope: A Non-inferior... | NCT01489605

Studies
GlideScope Groove vs. Standard GlideScope: A Non-inferiority Study

NCT01489605

Sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Status

Withdrawn

Last Update Posted

Feb 28, 2019Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Intubation, Orotracheal

Interventions

GlideScope Groove
Control: Standard GlideScope

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2019

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Device Withdrawn from market

Expanded Access Info

Start Date

Jul 2019Estimated

Primary Completion Date

Jun 2020Estimated

Completion Date

Jun 2020Estimated

First Submitted Date

Dec 8, 2011

First Submission Date that Met QC Criteria

Dec 8, 2011

First Posted Date

Dec 9, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 26, 2019

Last Update Posted Date

Feb 28, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Timothy Turkstra, Staff Anesthesiologist and Associate Professor, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sPrincipal Investigator

Lead Sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sOTHER

Collaborators

Name	Class
University of Western Ontario, Canada	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

See above. The primary outcome is time to intubation.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
GlideScope Groove	Device	Patients will be intubated using the GlideScope Groove device. (Verathon)	GlideScope Groove

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Duration of Intubation	Duration of Intubation - Mask removal to ETCO2 confirmation	Day 1

Secondary Outcomes

Measure	Description	Time Frame
Ease of intubation	Ease of intubation as noted by operator (measured on a 100 mm Visual Analogue Scale)	Day 1
Incidence of trauma	Incidence of trauma

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Any adult patient booked for elective surgery requiring orotracheal intubation.

Exclusion Criteria:

Any patient with cervical spine abnormalities.
Any patients with known or probable difficult airways.
Any patient requiring rapid sequence induction.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Timothy Turkstra, MD, M. Eng	UWO	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
London Health Sciences Center University Hospital		London	Ontario	N6A5A5	Canada
London Health Sciences Centre Victoria Campus