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

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

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.

Study Overview

• Status: Completed
• Conditions: Laryngeal Masks
• Intervention / Treatment: Device: Ambu AuraGain; Device: LMA Supreme

• Study Type: Interventional
• Enrollment (Actual): 170
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5T 2S8
      • Toronto Western Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oropharyngeal leak pressure (OLP) for each airway device after insertion	OLP is defined as 'the anesthesia circuit pressure at which a gas leak occurs around the SAD'.	Within 2-3 minutes after laryngeal mask insertion before start of surgery.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Phrayngolaryngeal complications	Complications like sore throat, dysphonia, dysphagia	at 1 hr, 2hr and 24 hrs after the surgery
Postoperative nausea and vomiting (PONV)	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.	at 1 hr, 2hr and 24 hrs after the surgery
Satisfaction of patient and the anesthesiologist with the device	Patient satisfaction (5 point scale)- 0 for very dissatisfied to 5 for very satisfied Anesthesiologist satisfaction scale- Low, Moderate and High	After 1hr in the post anesthesia care unit (PACU)

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Investigators: Principal Investigator: David T Wong, MD, Uinversity Health Network (UHN), Toronto

Publications and helpful links

General Publications

• Wong DT, Ooi A, Singh KP, Dallaire A, Meliana V, Lau J, Chung F, Singh M, Wong J. Comparison of oropharyngeal leak pressure between the Ambu(R) AuraGain and the LMA(R) Supreme supraglottic airways: a randomized-controlled trial. Can J Anaesth. 2018 Jul;65(7):797-805. doi: 10.1007/s12630-018-1120-4. Epub 2018 Mar 26.

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Actual): May 9, 2017
• Study Completion (Actual): May 9, 2017

Study Registration Dates

• First Submitted: June 22, 2016
• First Submitted That Met QC Criteria: June 24, 2016
• First Posted (Estimate): June 28, 2016

Study Record Updates

• Last Update Posted (Actual): June 6, 2017
• Last Update Submitted That Met QC Criteria: June 5, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 14-8360-B

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No