The i-GelTM. A Randomized, Crossover Study With the Laryn... | NCT01425151

Studies
The i-GelTM. A Randomized, Crossover Study With the Laryngeal Mask Airway ProSealTM in Anesthetized Pediatric Patients

NCT01425151

Sponsor

Schulthess Klinik

Status

Completed

Last Update Posted

Sep 22, 2011Estimated

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Device Success Rate
Device Performance

Interventions

i-Gel
ProSeal

Countries

Austria
Switzerland

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

Sep 2011

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

Jan 2010

Primary Completion Date

Sep 2011Actual

Completion Date

Sep 2011Actual

First Submitted Date

Aug 26, 2011

First Submission Date that Met QC Criteria

Aug 26, 2011

First Posted Date

Aug 29, 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

Sep 20, 2011

Last Update Posted Date

Sep 22, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

In the following randomized, crossover study, the investigators test the hypothesis that ease of insertion and oropharyngeal leak pressure differ between the LMA ProSealTM and the i-GelTM in anesthetized pediatric patients.

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

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
i-Gel	Active Comparator		Device: i-Gel
ProSeal	Experimental		Device: ProSeal

Interventions

Name	Type	Description	Arm Group Labels	Other Names
i-Gel	Device	Oropharyngeal leak pressure Insertion success	i-Gel

Measure	Description	Time Frame
Oropharyngeal leak pressure		10 Minutes

Measure	Description	Time Frame
Insertion success rate		1 Minute

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ASA I and II
Age 1.5-6 years

Exclusion Criteria:

known or predicted difficult airway
body mass index > 35 kg m-2
risk of aspiration

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Months

Maximum Age

6 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Christian Keller, MD, M.Sc.	Schulthess Klinik	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Klinik für Anästhesie und Allgemeine Intensivmedizin		Innsbruck		6020	Austria
Christian Keller