Ambu® Aura-ITM Versus Ambu Aura GainTM for Fiberoptic Intubation in Children

NCT ID: NCT03411655

Last Updated: 2018-01-26

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

2018-03-31

Study Completion Date

2018-08-31

Brief Summary

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The investigators test the hypothesis that fiberoptic intubation (time and success rate) differ between the Ambu® Aura-ITM and Ambu Aura GainTM in paralyzed anaesthetized pediatric patients

Detailed Description

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Conditions

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Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Ambu® Aura-ITM

Group Type ACTIVE_COMPARATOR

Ambu® Aura-ITM

Intervention Type DEVICE

Time and success rate

Ambu Aura GainTM

Group Type ACTIVE_COMPARATOR

Ambu Aura GainTM

Intervention Type DEVICE

Time and success rate

Interventions

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Ambu Aura GainTM

Time and success rate

Intervention Type DEVICE

Ambu® Aura-ITM

Time and success rate

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* ASA I-II
* age 1.5 - 6 years
* minor surgery
* extraglottic airway device

Exclusion Criteria

* age (\<18 months, \>6 years)
* weight (\<10 kg, \>20 kg)
* a known difficult airway
* risk of aspiration
Minimum Eligible Age

18 Months

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University Innsbruck

OTHER

Sponsor Role collaborator

Schulthess Klinik

OTHER

Sponsor Role lead

Responsible Party

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Christian Keller

MD M.Sc.

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Christian Keller, MD M.Sc.

Role: CONTACT

0041 44 3857462

Other Identifiers

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Schulthess_Anä_13

Identifier Type: -

Identifier Source: org_study_id

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