Infant Glidescope® Learning Curve | NCT01793727

Studies
Infant Glidescope® Learning Curve

NCT01793727

Sponsor

The Hospital for Sick Children

Status

Withdrawn

Last Update Posted

Apr 18, 2018Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Tracheal Intubation

Interventions

Glidescope videolaryngoscope

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

Apr 2018

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2011

Primary Completion Date

Jun 2012Actual

Completion Date

Jun 2012Actual

First Submitted Date

Feb 12, 2013

First Submission Date that Met QC Criteria

Feb 14, 2013

First Posted Date

Feb 15, 2013Estimated

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

Apr 16, 2018

Last Update Posted Date

Apr 18, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Cengiz Karsli, Primary Investigator, The Hospital for Sick ChildrenPrincipal Investigator

Lead Sponsor

The Hospital for Sick ChildrenOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

A prospective trial evaluating the learning curve associated with the use of a videolaryngoscope compared to conventional direct laryngoscopy in infants intubated by anesthesiology residents. Hypothesis: The learning curves of both instruments are equivalent.

Detailed Description

Not provided

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 intubation	Experimental	Comparison of direct laryngoscopy and Glidescope videolaryngoscopy	Device: Glidescope videolaryngoscope

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Glidescope videolaryngoscope	Device		Glidescope intubation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time to optimum visualization of the vocal cords		Under 2 minutes

Secondary Outcomes

Measure	Description	Time Frame
Time to tracheal intubation		Under 2 minutes

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

infants under 10 kg undergoing general anesthesia and requiring tracheal intubation

Exclusion Criteria:

Difficult airway, severe cardiorespiratory disease, emergency surgery

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

18 Months

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Cengiz Karsli, MD	The Hospital for Sick Children	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Hospital for Sick Children		Toronto	Ontario	M5G 1X8	Canada