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

Not Applicable

Completed

• Conditions: Laryngeal Masks
• Interventions: Device: LMA Supreme; Device: Ambu AuraGain

• Registration Number: NCT02816463
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-06-22
• Study First Submitted QC: 2016-06-24
• Study First Posted: 2016-06-28
• Primary Completion: 2017-05-09
• Study Completion: 2017-05-09
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-05
• Last Update Posted: 2017-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 170

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LMA Supreme (Group S)	LMA Supreme	Laryngeal mask Supreme will be used, and oropharyngeal leak pressure (OLP) after insertion will be recorded as the primary outcome measure
Ambu AuraGain (Group A)	Ambu AuraGain	Laryngeal mask Ambu AuraGain will be used, and oropharyngeal leak pressure (OLP) after insertion will be recorded as the primary outcome measure

Primary Outcome Measures

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

Name	Time	Method
Phrayngolaryngeal complications	at 1 hr, 2hr and 24 hrs after the surgery	Complications like sore throat, dysphonia, dysphagia
Satisfaction of patient and the anesthesiologist with the device	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
Postoperative nausea and vomiting (PONV)	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.

Trial Locations

Locations (1)

Toronto Western Hospital; 🇨🇦 Toronto, Ontario, Canada