Skip to main content
MedPathMedPath Home
Clinical Trials/NCT02566291
NCT02566291
Completed
Not Applicable

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

Johannes Gutenberg University Mainz1 site in 1 country364 target enrollmentJanuary 2015
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsAirway Remodeling

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Airway Remodeling
Sponsor
Johannes Gutenberg University Mainz
Enrollment
364
Locations
1
Primary Endpoint
Success rate
Status
Completed
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

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

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
January 2015
End Date
March 2015
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Johannes Gutenberg University Mainz
Responsible Party
Principal Investigator
Principal Investigator

Marc Kriege, MD

Marc Kriege, MD; Rüdiger Noppens, MD

Johannes Gutenberg University Mainz

Eligibility Criteria

Inclusion Criteria

  • •Age ≥ 18 Years
  • •No concurrent participation in another study
  • •capacity to consent
  • •Present written informed consent of the research participant
  • •Elective surgery under general anesthesia

Exclusion Criteria

  • •Age \<18 years
  • •Existing pregnancy
  • •Lack of consent
  • •inability to consent
  • •emergency patients
  • •Emergency situations in the context of a Difficult Airway Management
  • •ASA classification\> 3
  • •situations where the possibility of accumulated gastric contents
  • •Participation in another study

Outcomes

Primary Outcomes

Success rate

Time Frame: 70-98 Percent

overall and first attempt success rate

Secondary Outcomes

  • Time for insertion(5-120 seconds)
  • Leakage in ml.min(0-300 ml.min)

Study Sites (1)

Loading locations...

Similar Trials

Completed
Not Applicable
Ambu AuraGain vs LMA Supreme in Laparoscopic SurgeryLaparoscopyAirway ManagementSupraglottic Airway Devices
NCT02511652Hospital Clinic of Barcelona60
Completed
Not Applicable
Comparative Evaluation of Ambu AuraGain Laryngeal Mask and Proseal Laryngeal Mask AirwayLaryngeal Masks
NCT03139292Tata Main Hospital160
Unknown
Not Applicable
Crossover Study of the LMA SupremeTM vs Ambu-Aura GainTMAirway Morbidity
NCT02458794Schulthess Klinik200
Unknown
Not Applicable
A Comparison of the Ambu®AuraGain™ and the Laryngeal Mask Airway Supreme™ in Normal Airway PatientsSupraglottic Airway
NCT03108391Chinese Academy of Medical Sciences100
Completed
Not Applicable
Crossover Study With the ProSeal and Supreme Laryngeal Mask AirwayParalysis
NCT00626951Medical University Innsbruck94