Observational Study With Investigation of Two Second Generation Laryngeal Masks

Airway Remodeling Clinical Trial

— OSSGA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02566291
• Other study ID #: SGA 2014
• Status: Completed
• Phase: N/A
• First received: September 30, 2015
• Last updated: January 22, 2017
• Start date: January 2015
• Est. completion date: March 2015

Study information

• Verified date: January 2017
• Source: Johannes Gutenberg University Mainz
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 364
• Est. completion date: March 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Airway Remodeling

Intervention

Device:
• Success
Success rate and time for insertion

Locations

Country	Name	City	State
Germany	Department of Anaesthesiology;	Mainz	Rhineland-Palatinate

Sponsors (1)

Lead Sponsor	Collaborator
Johannes Gutenberg University Mainz

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Russo SG, Cremer S, Galli T, Eich C, Bräuer 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success rate	overall and first attempt success rate	70-98 Percent
Secondary	Time for insertion		5-120 seconds
Secondary	Leakage in ml.min		0-300 ml.min