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Prolonged Laryngeal Mask Airway ProSealTM Use

Sponsor
Schulthess Klinik (Other)
Overall Status
Completed
CT.gov ID
NCT03033979
Collaborator
(none)
7
Enrollment
1
Location
12
Actual Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    7 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Retrospective
    Official Title:
    Prolonged Use of the Laryngeal Mask Airway ProSealTM: a Report of Seven Cases Lasting 5-11 Hours
    Actual Study Start Date :
    Jan 1, 2015
    Actual Primary Completion Date :
    Dec 31, 2015
    Actual Study Completion Date :
    Dec 31, 2015

    Outcome Measures

    Primary Outcome Measures

    1. Feasibility of the LMA ProSealTM for prolonged use [30 Minutes]

      Oropharyngeal leak pressure

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • ASA 1 - 3

    • Age 19-85 yr

    • Written informed consent

    Exclusion Criteria:

    • Difficult airway

    • Non fasted

    • BMI > 35

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Christian Keller MD, M.Sc. Zürich Switzerland 8008

    Sponsors and Collaborators

    • Schulthess Klinik

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Schulthess Klinik
    ClinicalTrials.gov Identifier:
    NCT03033979
    Other Study ID Numbers:
    • Schulthess_Anä_9
    First Posted:
    Jan 27, 2017
    Last Update Posted:
    Jan 27, 2017
    Last Verified:
    Jan 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Jan 27, 2017