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Prolonged Laryngeal Mask Airway ProSealTM Use

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03033979
Recruitment Status : Completed
First Posted : January 27, 2017
Last Update Posted : January 27, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
Airway Management

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.

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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 : January 1, 2015
Actual Primary Completion Date : December 31, 2015
Actual Study Completion Date : December 31, 2015



Primary Outcome Measures :
  1. Feasibility of the LMA ProSealTM for prolonged use [ Time Frame: 30 Minutes ]
    Oropharyngeal leak pressure



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
We describe the use of the LMA ProSealTM in seven patients in a variety of clinical situations for procedures lasting more than 5 hours.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Difficult airway
  • Non fasted
  • BMI > 35

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03033979


Locations
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Switzerland
Christian Keller MD, M.Sc.
Zürich, Switzerland, 8008
Sponsors and Collaborators
Schulthess Klinik
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Responsible Party: Schulthess Klinik
ClinicalTrials.gov Identifier: NCT03033979    
Other Study ID Numbers: Schulthess_Anä_9
First Posted: January 27, 2017    Key Record Dates
Last Update Posted: January 27, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No