Clinical Trial: Observational Study With Investigation of Two Second Generation Laryngeal Masks

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Supraglottic Airways LMA Supreme and Ambu AuraGain in Clinical Practice: a Prospective Observational Study

Brief Summary: In a observational study the second-generation laryngeal masks LMA Supreme and Ambu AuraGain are investigated.

Detailed Summary: After approval from the local ethics committee, data were collected in a prospective, non- randomised study over a three-month period. When contra-indications for laryngeal mask use were absent anaesthesiologists used either Supreme (Teleflex Medical GmbH, Germany) or Gain (Ambu GmbH, Germany). Endpoints were the success rate and time to insertion.
Sponsor: Johannes Gutenberg University Mainz

Current Primary Outcome: Success rate [ Time Frame: 70-98 Percent ]

overall and first attempt success rate


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Time for insertion [ Time Frame: 5-120 seconds ]
  • Leakage in ml.min [ Time Frame: 0-300 ml.min ]


Original Secondary Outcome: Same as current

Information By: Johannes Gutenberg University Mainz

Dates:
Date Received: September 30, 2015
Date Started: January 2015
Date Completion:
Last Updated: January 22, 2017
Last Verified: January 2017