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RCT:Oropharyngeal Leak Pressure (OLP) - Ambu AuraGain vs LMA Supreme (OLP-Aur/Sup)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02816463
Recruitment Status : Completed
First Posted : June 28, 2016
Last Update Posted : June 6, 2017
Information provided by (Responsible Party):
David Wong, University Health Network, Toronto

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.

Condition or disease Intervention/treatment Phase
Laryngeal Masks Device: Ambu AuraGain Device: LMA Supreme Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Official Title: Comparison of Oropharyngeal Leak Pressure Between the Ambu AuraGain and the LMA Supreme - a Prospective Randomized Trial
Study Start Date : June 2016
Actual Primary Completion Date : May 9, 2017
Actual Study Completion Date : May 9, 2017

Arm Intervention/treatment
Experimental: Ambu AuraGain (Group A)
Laryngeal mask Ambu AuraGain will be used, and oropharyngeal leak pressure (OLP) after insertion will be recorded as the primary outcome measure
Device: Ambu AuraGain
Active Comparator: LMA Supreme (Group S)
Laryngeal mask Supreme will be used, and oropharyngeal leak pressure (OLP) after insertion will be recorded as the primary outcome measure
Device: LMA Supreme

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Phrayngolaryngeal complications [ Time Frame: at 1 hr, 2hr and 24 hrs after the surgery ]
    Complications like sore throat, dysphonia, dysphagia

  2. Postoperative nausea and vomiting (PONV) [ Time Frame: at 1 hr, 2hr and 24 hrs after the surgery ]
    PONV in the post anesthesia care unit (PACU)- PONV will be recorded as only None for No PONV and Yes for present. Severity grading will not be recorded.

  3. Satisfaction of patient and the anesthesiologist with the device [ Time Frame: After 1hr in the post anesthesia care unit (PACU) ]
    Patient satisfaction (5 point scale)- 0 for very dissatisfied to 5 for very satisfied Anesthesiologist satisfaction scale- Low, Moderate and High

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria

ASA physical status I to III Adults more above 18 years Ambulatory surgeries under general anesthesia in supine position requiring laryngeal masks- Knee arthroscopies, bladder tumour resections, hand, eye and general surgical procedures Muscle relaxant not required

Exclusion Criteria

Reduced mouth opening less than 2.5 cms Recent upper respiratory tract infection and sore throat in last 2 weeks Contraindications to laryngeal mask use as in morbid obesity- BMI more than 40 and severe symptomatic esophageal reflux disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02816463

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Canada, Ontario
Toronto Western Hospital
Toronto, Ontario, Canada, M5T 2S8
Sponsors and Collaborators
University Health Network, Toronto
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Principal Investigator: David T Wong, MD Uinversity Health Network (UHN), Toronto
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: David Wong, Professor, University Health Network, Toronto Identifier: NCT02816463    
Other Study ID Numbers: 14-8360-B
First Posted: June 28, 2016    Key Record Dates
Last Update Posted: June 6, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No