Observational Study With Investigation of Two Second Generation Laryngeal Masks

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

Total Enrollment

364 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-31

Study Completion Date

2015-03-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Airway Remodeling

Study Design

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Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

PROSPECTIVE

Study Groups

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Supreme Group

Measuring Success rate and Insertion Time

Success

Intervention Type DEVICE

Success rate and time for insertion

Gain Group

Measuring Success rate and Insertion Time

Success

Intervention Type DEVICE

Success rate and time for insertion

Interventions

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Success

Success rate and time for insertion

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No