Laryngeal Mask Ambu Aura Once vs. Supreme in Children | NCT01718782

Studies
Laryngeal Mask Ambu Aura Once vs. Supreme in Children

NCT01718782

Sponsor

Medical University Innsbruck

Status

Withdrawn

Last Update Posted

May 15, 2014Estimated

Enrollment

0Actual

Phase

Not Applicable

Conditions

Apnea

Interventions

laryngeal mask Ambu AuraOnce
laryngeal mask LMA Supreme

Countries

Austria

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

May 2014

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Other studies with the same protocol have already published.

Expanded Access Info

Start Date

Mar 2013

Primary Completion Date

May 2014Actual

Completion Date

May 2014Actual

First Submitted Date

Sep 27, 2012

First Submission Date that Met QC Criteria

Oct 30, 2012

First Posted Date

Oct 31, 2012Estimated

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

May 14, 2014

Last Update Posted Date

May 15, 2014Estimated

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 purpose of this study is determine safety and efficiency of mechanical ventilation in children with two different types of single use laryngeal masks (Ambu AuraOnce vs. LMA Supreme). The main interest is leakage pressure of oropharynx and stomach. The null hypothesis is that leakage pressures of Ambu AuraOnce and LMA Supreme are equivalent. The alternative hypothesis is that there is a difference in leakage pressure.

Detailed Description

Before starting surgery patients will be anesthetised and airway managed either with LMA Ambu AuraOnce or Supreme. Ventilation parameters, stomach inflation, and hemodynamic parameters will be measured.

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
laryngeal mask Ambu AuraOnce	Active Comparator	laryngeal mask Ambu AuraOnce	Device: laryngeal mask Ambu AuraOnce
laryngeal mask LMA Supreme	Active Comparator	laryngeal mask LMA Supreme	Device: laryngeal mask LMA Supreme

Interventions

Name	Type	Description	Arm Group Labels	Other Names
laryngeal mask Ambu AuraOnce	Device	airway management and mechanical ventilation with laryngeal mask	laryngeal mask Ambu AuraOnce

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Leakage pressure [cmH2O]	After ventilation has been established the leakage pressure will be measured, ie 1min after establishing ventilation	1min

Secondary Outcomes

Measure	Description	Time Frame
Efficient ventilation [mL],	After ventilation has been established the efficient ventilation, tidal volume and stomach inflation will be measured, ie 3min after establishing ventilation	3min
tidal volume [mL],

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Children aged 1-10 years
ASA I - III
Elective procedure in general anaesthesia
Parental informed consent

Exclusion Criteria:

Non fasting patient
Body mass index > 35 kg/m2
Cervical spine pathologies or peripheral neurologic deficiences
Malformations of upper airway or head
Anamnestic hiatus hernia or esophageal reflux
Status post operation of stomach or esophagus
Recurrent respiratory infection or obstructive airway disease
Non elective procedure

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

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
Peter Paal, MD,DESA,EDIC	University Hospital Innsbruck, Department of Anaesthesia + Intensive Care	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Innsbruck		Innsbruck	Tyrol	6020	Austria

Condition Browse Module

MeSH Terms

ID	Term
D001049	Apnea
D053120	Respiratory Aspiration

Ancestor Terms

ID	Term
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D012818	Signs and Symptoms, Respiratory
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided