Evaluation of Airtraq in Pediatric | NCT00917566

Studies
Evaluation of Airtraq in Pediatric

NCT00917566

Sponsor

King Khaled Eye Specialist Hospital

Status

Completed

Last Update Posted

Nov 19, 2009Estimated

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Intubation

Interventions

Airtraq
Macintoch

Countries

Saudi Arabia

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

Nov 2009

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

Apr 2009

Primary Completion Date

Nov 2009Actual

Completion Date

Nov 2009Actual

First Submitted Date

Jun 9, 2009

First Submission Date that Met QC Criteria

Jun 9, 2009

First Posted Date

Jun 10, 2009Estimated

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

Nov 18, 2009

Last Update Posted Date

Nov 19, 2009Estimated

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

This study indented to evaluate the use of Optical laryngoscope in pediatric

Detailed Description

The authors are welling to study how intubation will differ if Airtraq optical laryngoscope used in pediatrics

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

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Airtraq group	Active Comparator	Use Airtraq for intubation	Device: Airtraq
Macintoch gorup	Active Comparator	Use Macintoch laryngoscope for intubation	Device: Macintoch

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Airtraq	Device	intubation with airtraq	Airtraq group	Optical laryngoscope

Measure	Description	Time Frame
Duration of intubation		two minutes

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy children undergoing general anesthesia required tracheal intubation.

Exclusion Criteria:

History of difficult intubation.
Risk of aspiration.
Children with cardiovascular disease.
Children with respiratory disease.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

10 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Waleed Riad, MD, AB, SB	King Khaled Eye Specialist Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
king Khaled Eye Specialist hospital		Riyadh	Riyadh Region	11462	Saudi Arabia