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Clinical Trials/NCT03033979
NCT03033979
Completed
Not Applicable

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

Schulthess Klinik1 site in 1 country7 target enrollmentJanuary 1, 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Airway Management
Sponsor
Schulthess Klinik
Enrollment
7
Locations
1
Primary Endpoint
Feasibility of the LMA ProSealTM for prolonged use
Status
Completed
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2015
End Date
December 31, 2015
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Difficult airway
  • Non fasted
  • BMI \> 35

Outcomes

Primary Outcomes

Feasibility of the LMA ProSealTM for prolonged use

Time Frame: 30 Minutes

Oropharyngeal leak pressure

Study Sites (1)

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