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The i-GelTM. A Randomized, Crossover Study With the Laryngeal Mask Airway ProSealTM in Anesthetized Pediatric Patients

NCT ID: NCT01425151

Last Updated: 2011-09-22

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

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2011-09-30

Brief Summary

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In the following randomized, crossover study, the investigators test the hypothesis that ease of insertion and oropharyngeal leak pressure differ between the LMA ProSealTM and the i-GelTM in anesthetized pediatric patients.

Detailed Description

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Conditions

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Device Success Rate Device Performance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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i-Gel

Group Type ACTIVE_COMPARATOR

i-Gel

Intervention Type DEVICE

Oropharyngeal leak pressure Insertion success

ProSeal

Group Type EXPERIMENTAL

ProSeal

Intervention Type DEVICE

Oropharyngeal leak pressure Insertion success

Interventions

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i-Gel

Oropharyngeal leak pressure Insertion success

Intervention Type DEVICE

ProSeal

Oropharyngeal leak pressure Insertion success

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* ASA I and II
* Age 1.5-6 years

Exclusion Criteria

* known or predicted difficult airway
* body mass index \> 35 kg m-2
* 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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Schulthess Klinik

OTHER

Sponsor Role lead

Responsible Party

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ChristianKeller

MD, M.Sc.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christian Keller, MD, M.Sc.

Role: PRINCIPAL_INVESTIGATOR

Schulthess Klinik

Locations

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Klinik für Anästhesie und Allgemeine Intensivmedizin

Innsbruck, , Austria

Site Status

Christian Keller

Zurich, , Switzerland

Site Status

Countries

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Austria Switzerland

Other Identifiers

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Schulthess_Anä_2

Identifier Type: -

Identifier Source: org_study_id