Observational Study With Investigation of Two Second Generation Laryngeal Masks

Supraglottic Airways LMA Supreme and Ambu AuraGain in Clinical Practice: a Prospective Observational Study

NCT02566291•Johannes Gutenberg University Mainz

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Summary

In a observational study the second-generation laryngeal masks LMA Supreme and Ambu AuraGain are investigated.

Detailed Description

After approval from the local ethics committee, data were collected in a prospective, non- randomised study over a three-month period. When contra-indications for laryngeal mask use were absent anaesthesiologists used either Supreme (Teleflex Medical GmbH, Germany) or Gain (Ambu GmbH, Germany). Endpoints were the success rate and time to insertion.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Age ≥ 18 Years
•No concurrent participation in another study
•capacity to consent
•Present written informed consent of the research participant
•Elective surgery under general anesthesia

Exclusion Criteria

•Age \<18 years
•Existing pregnancy
•Lack of consent
•inability to consent
•emergency patients
•Emergency situations in the context of a Difficult Airway Management
•ASA classification\> 3
•situations where the possibility of accumulated gastric contents
•Participation in another study

Locations (1)

Department of Anaesthesiology;

Mainz, Rhineland-Palatinate, Germany

Key Dates

Start Date

January 1, 2015

Primary Completion Date

January 1, 2015

Completion Date

March 1, 2015

Last Updated

January 24, 2017

Enrollment

364

ACTUAL participants

Conditions

Airway Remodeling

Interventions

Success

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 24, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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