Glidescope Videolaryngoscope and Macintosh Laryngoscope i... | NCT03326882

Studies
Glidescope Videolaryngoscope and Macintosh Laryngoscope in Children

NCT03326882

Sponsor

Sisli Hamidiye Etfal Training and Research Hospital

Status

Completed

Last Update Posted

Oct 31, 2017Actual

Enrollment

80Actual

Phase

Not Applicable

Conditions

Anesthesiology
Pediatrics

Interventions

Endotracheal intubation

Countries

Not provided

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

Oct 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2016

Primary Completion Date

Mar 2016Actual

Completion Date

Apr 2016Actual

First Submitted Date

Oct 24, 2017

First Submission Date that Met QC Criteria

Oct 30, 2017

First Posted Date

Oct 31, 2017Actual

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

Oct 30, 2017

Last Update Posted Date

Oct 31, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Canan Tulay ISIL, M.D., Sisli Hamidiye Etfal Training and Research HospitalPrincipal Investigator

Lead Sponsor

Sisli Hamidiye Etfal Training and Research HospitalOTHER

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

The main objective of this study was to evaluate the intubation time of Glidescope compared with Macintoch laryngoscope in pediatric patients, ease of intubation, and cardiovascular changes during intubation.

Detailed Description

This was a prospective randomized clinical study to be performed in pediatric patients older than 1 years who are undergoing surgical procedures requiring endotracheal intubation. Time to endotracheal intubation was compared between patients intubated using a GlideScope® video laryngoscope, and those intubated by standard direct laryngoscopy. The main objective of this study was to evaluate the intubation time of Glidescope compared with Macintoch laryngoscope in pediatric patients, ease of intubation, and cardiovascular changes during 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

80Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Glidescope	Active Comparator	A device for endotracheal intubation	Device: Endotracheal intubation
Macintosh laringoscope	Active Comparator	A device for endotracheal intubation	Device: Endotracheal intubation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Endotracheal intubation	Device		Glidescope Macintosh laringoscope	Glidescope video laryngoscope

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Duration of Intubation	Time from laryngoscopy to intubation	Intraoperative

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ASA physical status I-II patients,
scheduled for elective surgery under general anesthesia with endotracheal intubation

Exclusion Criteria:

risk of pulmonary aspiration,
presence of difficult intubation,
emergency surgery,
cardiovascular disease,
respiratuar disease,
hemodynamic instability.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

12 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Canan Tulay Isil	Sisli Hamidiye Etfal Training and Research Hospital	Study Director

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19128325	Background	Holm-Knudsen RJ, Rasmussen LS. Paediatric airway management: basic aspects. Acta Anaesthesiol Scand. 2009 Jan;53(1):1-9. doi: 10.1111/j.1399-6576.2008.01794.x.

ID	Term
D058109	Airway Management
D013812	Therapeutics
D007440	Intubation
D008919	Investigative Techniques