Gastric Insufflation and Laryngeal Mask Airway

November 18, 2014 updated by: Lionel Bouvet
Comparison of the incidence of gastric insufflation between two kinds of laryngeal masks airways: LMA SupremeTM vs Ambu AuraOnceTM

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Lyon, France, 69003
        • Recruiting
        • Hospices Civils de Lyon
        • Contact:
          • Bouvet
          • Phone Number: + 33 4 72 11 69 88

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ASA 1 or 2
  • Age > 18 yrs
  • Use of laryngeal mask airway required

Exclusion Criteria:

  • risk of pulmonary aspiration of gastric contents
  • Contraindication for the use of laryngeal mask airway
  • Tracheal intubation required
  • Patient's refusal

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: LMA SupremeTM
Device: LMA SupremeTM
Sham Comparator: Ambu AuraOnce
Device: AuraOnceTM

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
incidence of gastric insufflation
Time Frame: during pulmonary ventilation through the laryngeal mask airway
during pulmonary ventilation through the laryngeal mask airway

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lionel Bouvet

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Anticipated)

July 1, 2015

Study Completion

December 7, 2022

Study Registration Dates

First Submitted

March 21, 2014

First Submitted That Met QC Criteria

March 24, 2014

First Posted (Estimate)

March 27, 2014

Study Record Updates

Last Update Posted (Estimate)

November 19, 2014

Last Update Submitted That Met QC Criteria

November 18, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2013-A01852-43

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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