Ambu AuraOnce Versus Ambu AuraGain LM in Children

NCT ID: NCT02811042

Last Updated: 2016-06-23

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2017-03-31

Brief Summary

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The investigators test the hypothesis that oropharyngeal leak pressure and fiberoptic position differ between the size 2 LM Ambu AuraOnce and the LM Ambu AuraGain in non-paralyzed anaesthetized pediatric patients.

Detailed Description

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Conditions

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Airway Management

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Oropharyngeal leak pressure

Ambu AuraOnce

Group Type ACTIVE_COMPARATOR

Ambu AuraOnce

Intervention Type DEVICE

Oropharyngeal leak pressure was determined by closing the expiratory valve of the anaesthesia breathing system and a fixed gas flow of 3 l minute-1. The airway pressure at which an equilibrium was reached was noted (maximum allowed 40 cm H2O).

Fiberoptic position

Ambu AuraGain

Group Type EXPERIMENTAL

Ambu AuraGain

Intervention Type DEVICE

The airway tube view was scored using an established scoring system (4=only vocal cords visible; 3=vocal cords plus posterior epiglottis; 2=vocal cords plus anterior epiglottis; 1=vocal cords not seen)

Interventions

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Ambu AuraOnce

Oropharyngeal leak pressure was determined by closing the expiratory valve of the anaesthesia breathing system and a fixed gas flow of 3 l minute-1. The airway pressure at which an equilibrium was reached was noted (maximum allowed 40 cm H2O).

Intervention Type DEVICE

Ambu AuraGain

The airway tube view was scored using an established scoring system (4=only vocal cords visible; 3=vocal cords plus posterior epiglottis; 2=vocal cords plus anterior epiglottis; 1=vocal cords not seen)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* ASA I-II
* age 1 - 16 years
* minor surgery
* extraglottic airway device

Exclusion Criteria

* age (\<12 months, \>16 years)
* weight (\<12 kg, \>50 kg)
* a known difficult airway
* risk of aspiration
Minimum Eligible Age

1 Year

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Salzburg

OTHER

Sponsor Role collaborator

Schulthess Klinik

OTHER

Sponsor Role lead

Responsible Party

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ChristianKeller

PD Dr. med. M.Sc.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Zentralkrankenhaus Bozen

Bolzano, , Italy

Site Status

Christian Keller MD, M.Sc.

Zurich, , Switzerland

Site Status

Countries

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Italy Switzerland

References

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Stogermuller B, Ofner S, Ziegler B, Keller C, Moser B, Gasteiger L. Ambu(R) Aura Gain versus Ambu(R) Aura Once in children: a randomized, crossover study assessing oropharyngeal leak pressure and fibreoptic position. Can J Anaesth. 2019 Jan;66(1):57-62. doi: 10.1007/s12630-018-1235-7. Epub 2018 Oct 12.

Reference Type DERIVED
PMID: 30315506 (View on PubMed)

Other Identifiers

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Schulthess_Anä_7

Identifier Type: -

Identifier Source: org_study_id

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