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Observational Study With Investigation of Two Second Generation Laryngeal Masks

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02566291
Acronym
OSSGA
Enrollment
364
Registered
2015-10-02
Start date
2015-01-31
Completion date
2015-03-31
Last updated
2017-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Airway Remodeling

Keywords

laryngeal mask, airway leakage, airway morbidity

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.

Interventions

DEVICESuccess

Success rate and time for insertion

Sponsors

Johannes Gutenberg University Mainz
Lead SponsorOTHER

Study design

Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Success rate70-98 Percentoverall and first attempt success rate

Secondary

MeasureTime frame
Time for insertion5-120 seconds
Leakage in ml.min0-300 ml.min

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026