Prolonged Laryngeal Mask Airway ProSealTM Use

NCT ID: NCT03033979

Last Updated: 2017-01-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 7 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-01-01
• Study Completion Date: 2015-12-31

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.

Conditions

Airway Management

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Difficult airway
• Non fasted
• BMI > 35

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Schulthess Klinik

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Christian Keller MD, M.Sc.

Zurich, , Switzerland

Countries

Switzerland

Other Identifiers

Schulthess_Anä_9

Identifier Type: -

Identifier Source: org_study_id