Observational Study With Investigation of Two Second Generation Laryngeal Masks
OSSGA
Supraglottic Airways LMA Supreme and Ambu AuraGain in Clinical Practice: a Prospective Observational Study
1 other identifier
observational
364
1 country
1
Brief Summary
In a observational study the second-generation laryngeal masks LMA Supreme and Ambu AuraGain are investigated.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2015
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedFirst Submitted
Initial submission to the registry
September 30, 2015
CompletedFirst Posted
Study publicly available on registry
October 2, 2015
CompletedJanuary 24, 2017
January 1, 2017
Same day
September 30, 2015
January 22, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Success rate
overall and first attempt success rate
70-98 Percent
Secondary Outcomes (2)
Time for insertion
5-120 seconds
Leakage in ml.min
0-300 ml.min
Study Arms (2)
Supreme Group
Measuring Success rate and Insertion Time
Gain Group
Measuring Success rate and Insertion Time
Interventions
Eligibility Criteria
Inclusion criteria: Age \> 18 Years informed consent elective surgery undergoing general anesthesia non-pregnant
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Anaesthesiology;
Mainz, Rhineland-Palatinate, D55131, Germany
Related Publications (1)
Russo SG, Cremer S, Galli T, Eich C, Brauer A, Crozier TA, Bauer M, Strack M. Randomized comparison of the i-gel, the LMA Supreme, and the Laryngeal Tube Suction-D using clinical and fibreoptic assessments in elective patients. BMC Anesthesiol. 2012 Aug 7;12:18. doi: 10.1186/1471-2253-12-18.
PMID: 22871204RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marc MK Kriege, MD
University JG, Mainz
Study Design
- Study Type
- observational
- Observational Model
- ECOLOGIC OR COMMUNITY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Marc Kriege, MD; Rüdiger Noppens, MD
Study Record Dates
First Submitted
September 30, 2015
First Posted
October 2, 2015
Study Start
January 1, 2015
Primary Completion
January 1, 2015
Study Completion
March 1, 2015
Last Updated
January 24, 2017
Record last verified: 2017-01
Data Sharing
- IPD Sharing
- Will not share