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

NCT ID: NCT01692522

Last Updated: 2014-08-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2014-08-31

Brief Summary

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

Detailed Description

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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

Conditions

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Intubation; Difficult

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Participants

Study Groups

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Ambu Aura-i

intubation

Group Type EXPERIMENTAL

Intubation

Intervention Type PROCEDURE

visualized blind intubation

AirQ

intubation

Group Type ACTIVE_COMPARATOR

Intubation

Intervention Type PROCEDURE

visualized blind intubation

Interventions

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Intubation

visualized blind intubation

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 0-16 years
* max 50kg
* ASA I-III

Exclusion Criteria

* risk of aspiration
* known difficult airway
* congenital malformations respiratory tract
Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role lead

Responsible Party

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Lorenz Theiler

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Robert Greif, MD MME FERC

Role: STUDY_CHAIR

University Dept Anesthesiology and Pain Therapy, University of Berne, Switzerland

Locations

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Bern University Hospital

Bern, Canton of Bern, Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type DERIVED
PMID: 26061874 (View on PubMed)

Other Identifiers

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093/12

Identifier Type: -

Identifier Source: org_study_id

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