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Clinical Trials/NCT02816463
NCT02816463
Completed
Not Applicable

Comparison of Oropharyngeal Leak Pressure Between the Ambu AuraGain and the LMA Supreme - a Prospective Randomized Trial

University Health Network, Toronto1 site in 1 country170 target enrollmentJune 2016
ConditionsLaryngeal Masks

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Laryngeal Masks
Sponsor
University Health Network, Toronto
Enrollment
170
Locations
1
Primary Endpoint
Oropharyngeal leak pressure (OLP) for each airway device after insertion
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

The purpose of this study is to determine whether the leak pressure of the recently introduced laryngeal mask airway, Ambu AuraGain performs superior to the established laryngeal mask LMA Supreme in surgical patients undergoing general anesthesia. This leak pressure is the pressure at which a gas leaks around the airway, which is a key marker of efficacy and safety of its use; a higher leak pressure suggests a better seal between the artificial airway and patient's airway.

Registry
clinicaltrials.gov
Start Date
June 2016
End Date
May 9, 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

David Wong

Professor

University Health Network, Toronto

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Oropharyngeal leak pressure (OLP) for each airway device after insertion

Time Frame: Within 2-3 minutes after laryngeal mask insertion before start of surgery.

OLP is defined as 'the anesthesia circuit pressure at which a gas leak occurs around the SAD'.

Secondary Outcomes

  • Satisfaction of patient and the anesthesiologist with the device(After 1hr in the post anesthesia care unit (PACU))
  • Postoperative nausea and vomiting (PONV)(at 1 hr, 2hr and 24 hrs after the surgery)
  • Phrayngolaryngeal complications(at 1 hr, 2hr and 24 hrs after the surgery)

Study Sites (1)

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