Observational Study With Investigation of Two Second Generation Laryngeal Masks (OSSGA)

Johannes Gutenberg University (JGU)

Status: Completed

Conditions: Airway Remodeling

Treatments: Device: Success

Study type: Observational

Funder types: Other

Identifiers

NCT02566291

SGA 2014

Details and patient eligibility

About

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

Full 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.

Enrollment: 364 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

364 participants in 2 patient groups

Supreme Group

Description:

Measuring Success rate and Insertion Time

Treatment:

Device: Success

Gain Group

Description:

Measuring Success rate and Insertion Time

Treatment:

Device: Success