Prolonged Laryngeal Mask Airway ProSealTM Use

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.

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Key information

Conditions

Airway Management

Age range

19 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Christian Keller MD, M.Sc.

Zurich, 8008, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Difficult airway
Non fasted
BMI > 35

Treatment and study plan

Primary outcomes

Feasibility of the LMA ProSealTM for prolonged use

Time frame: 30 Minutes

Oropharyngeal leak pressure

Sponsors and collaborators

Lead sponsor

Schulthess Klinik

Other

Registry information

Official study title

Prolonged Use of the Laryngeal Mask Airway ProSealTM: a Report of Seven Cases Lasting 5-11 Hours

Important dates

Study start: 2015
Primary completion: 2015
Study completion: 2015
First posted: Jan 27, 2017
Registry last updated: Jan 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed