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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03033979
Other study ID # Schulthess_Anä_9
Secondary ID
Status Completed
Phase N/A
First received January 25, 2017
Last updated January 26, 2017
Start date January 1, 2015
Est. completion date December 31, 2015

Study information

Verified date January 2017
Source Schulthess Klinik
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 7
Est. completion date December 31, 2015
Est. primary completion date December 31, 2015
Accepts healthy volunteers No
Gender All
Age group 19 Years to 85 Years
Eligibility Inclusion Criteria:

- ASA 1 - 3

- Age 19-85 yr

- Written informed consent

Exclusion Criteria:

- Difficult airway

- Non fasted

- BMI > 35

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Switzerland Christian Keller MD, M.Sc. Zürich

Sponsors (1)

Lead Sponsor Collaborator
Schulthess Klinik

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Feasibility of the LMA ProSealTM for prolonged use Oropharyngeal leak pressure 30 Minutes
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