Observational Study With Investigation of Two Second Generation Laryngeal Masks
Completed
- Conditions
- Airway Remodeling
- Interventions
- Device: Success
- Registration Number
- NCT02566291
- Lead Sponsor
- Johannes Gutenberg University Mainz
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 364
Inclusion Criteria
- Age ā„ 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Supreme Group Success Measuring Success rate and Insertion Time Gain Group Success Measuring Success rate and Insertion Time
- Primary Outcome Measures
Name Time Method Success rate 70-98 Percent overall and first attempt success rate
- Secondary Outcome Measures
Name Time Method Time for insertion 5-120 seconds Leakage in ml.min 0-300 ml.min
Trial Locations
- Locations (1)
Department of Anaesthesiology;
š©šŖMainz, Rhineland-Palatinate, Germany