Observational Study With Investigation of Two Second Generation Laryngeal Masks

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02566291
• Date of registration: 30/09/2015
• Prospective Registration: No
• Primary sponsor: Johannes Gutenberg University Mainz
• Public title: Observational Study With Investigation of Two Second Generation Laryngeal Masks OSSGA
• Scientific title: Supraglottic Airways LMA Supreme and Ambu AuraGain in Clinical Practice: a Prospective Observational Study
• Date of first enrolment: January 2015
• Target sample size: 364
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02566291
• Study type: Observational
• Phase: N/A

Countries of recruitment

Germany

Contacts

• Name: Marc MK Kriege, MD
• Affiliation: University JG, Mainz

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Airway Remodeling

Intervention(s)

Device: Success

Primary Outcome(s)

Success rate [Time Frame: 70-98 Percent]

Secondary Outcome(s)

Leakage in ml.min [Time Frame: 0-300 ml.min]

Time for insertion [Time Frame: 5-120 seconds]

Secondary ID(s)

SGA 2014

Source(s) of Monetary Support

Please refer to primary and secondary sponsors