Laryngeal Mask Airway in Lower Abdominal Surgery

NCT ID: NCT02040324

Last Updated: 2014-01-20

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

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2012-03-31

Brief Summary

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We measure in this study lung function of 100 patients immediately after major lower abdominal surgery. We compare lung function, when either endotracheal intubation, or laryngeal masks are used for airway protection during surgery. The hypothesis is that the use of laryngeal masks is associated with less impairment of lung function in the immediate postoperative phase.

Detailed Description

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Conditions

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Major Lower Abdominal Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Endotracheal Intubation

Clinical routine for longer lasting procedures

Group Type ACTIVE_COMPARATOR

Endotracheal tube

Intervention Type DEVICE

Laryngeal Mask

Laryngeal mask with gastric access and drainage as airway management instead of endotracheal intubation

Group Type EXPERIMENTAL

Laryngeal mask with gastric access

Intervention Type DEVICE

Interventions

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Laryngeal mask with gastric access

Intervention Type DEVICE

Endotracheal tube

Intervention Type DEVICE

Eligibility Criteria

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Exclusion Criteria

\- increased risk of aspiration due to hiatal hernia, morbid obesity, or facial malformations
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role lead

Responsible Party

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Prof. Dr. med. Daniel Reuter

Professor of Anesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Daniel A Reuter, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinikum Hamburg-Eppendorf

Other Identifiers

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LMA UKE

Identifier Type: -

Identifier Source: org_study_id

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