Comparison of the Laryngeal Mask Ambu Aura-i Versus AirQ... | NCT01692522

Studies
Comparison of the Laryngeal Mask Ambu Aura-i Versus AirQ in Children

NCT01692522

Sponsor

Insel Gruppe AG, University Hospital Bern

Status

Completed

Last Update Posted

Aug 18, 2014Estimated

Enrollment

80Estimated

Phase

Not Applicable

Conditions

Intubation; Difficult

Interventions

Intubation

Countries

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

Aug 2014

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

Oct 2012

Primary Completion Date

Aug 2014Actual

Completion Date

Aug 2014Actual

First Submitted Date

Sep 17, 2012

First Submission Date that Met QC Criteria

Sep 20, 2012

First Posted Date

Sep 25, 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

Aug 14, 2014

Last Update Posted Date

Aug 18, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Lorenz Theiler, Principal Investigator, Insel Gruppe AG, University Hospital BernPrincipal Investigator

Lead Sponsor

Insel Gruppe AG, University Hospital BernOTHER

Collaborators

Not provided

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

The investigators will evaluate the first attempt visualized blind intubation through an Ambu Aura-i versus an AirQ.

Detailed Description

After induction of anesthesia, one of the 2 laryngeal masks (Ambu or AirQ) is going to be inserted. Following this, a tracheal tube is mounted on a fiberoptic scope with the tip of the scope behind the tip of the tube. This way, the tracheal tube is not guided by the scope, but the scope visualizes the course of the tracheal tube in the laryngeal mask and the glottic opening as if the tracheal tube was advanced blindly: Visualized blind 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

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ambu Aura-i	Experimental	intubation	Procedure: Intubation
AirQ	Active Comparator	intubation	Procedure: Intubation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Intubation	Procedure	visualized blind intubation	AirQ Ambu Aura-i

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
First attempt visualized blind intubation success rate		how many seconds needed

Secondary Outcomes

Measure	Description	Time Frame
Overall intubation success rate		how many seconds needed

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

0-16 years
max 50kg
ASA I-III

Exclusion Criteria:

risk of aspiration
known difficult airway
congenital malformations respiratory tract

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

16 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Robert Greif, MD MME FERC	University Dept Anesthesiology and Pain Therapy, University of Berne, Switzerland	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bern University Hospital		Bern	Canton of Bern		Switzerland

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26061874	Derived	Kleine-Brueggeney M, Nicolet A, Nabecker S, Seiler S, Stucki F, Greif R, Theiler L. Blind intubation of anaesthetised children with supraglottic airway devices AmbuAura-i and Air-Q cannot be recommended: A randomised controlled trial. Eur J Anaesthesiol. 2015 Sep;32(9):631-9. doi: 10.1097/EJA.0000000000000261.

ID	Term
D013812	Therapeutics
D008919	Investigative Techniques