Prolonged Laryngeal Mask Airway ProSealTM Use

Completed

• Conditions: Airway Management

• Registration Number: NCT03033979
• Lead Sponsor: Schulthess Klinik

Brief Summary

The investigators conclude that use of the LMA ProSealTM for prolonged procedures is feasible. In principle, it should be safer and more effective than the LMA ClassicTM provided basic guidelines are followed.

Detailed Description

There is controversy concerning use of the classic laryngeal mask airway (LMA ClassicTM) for prolonged procedures, particularly over 2 hours, as some clinicians consider it unsuitable for positive pressure ventilation (needed to counter the alleged progressive respiratory fatigue with time) and/or unsuitable for airway protection (needed to counter the alleged progressive increase in aspiration risk with time). The LMA ProSealTM is a laryngeal mask device with a modified cuff to facilitate ventilation and a drain tube to provide airway protection. In principle, the LMA ProSealTM should be more suitable than the LMA ClassicTM for prolonged procedures; however, there are only four reports and one case series.

Study Timeline

• Study Start: 2015-01-01
• Primary Completion: 2015-12-31
• Study Completion: 2015-12-31
• Status Verified: 2017-01
• Study First Submitted: 2017-01-25
• Study First Submitted QC: 2017-01-26
• Last Update Submitted: 2017-01-26
• Study First Posted: 2017-01-27
• Last Update Posted: 2017-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

• ASA 1 - 3
• Age 19-85 yr
• Written informed consent

Exclusion Criteria

• Difficult airway
• Non fasted
• BMI > 35

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Feasibility of the LMA ProSealTM for prolonged use	30 Minutes	Oropharyngeal leak pressure

Trial Locations

Locations (1)

Christian Keller MD, M.Sc.; 🇨🇭 Zürich, Switzerland