Prolonged Laryngeal Mask Airway ProSealTM Use

Airway Management Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03033979
• Other study ID #: Schulthess_Anä_9
• 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
• 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

Related Conditions & MeSH terms

• Airway Management

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