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

University Health Network, Toronto

Status: Completed

Conditions: Laryngeal Masks

Treatments: Device: Ambu AuraGain; Device: LMA Supreme

Study type: Interventional

Funder types: Other

Identifiers

NCT02816463

14-8360-B

Details and patient eligibility

About

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.

Enrollment: 170 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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170 participants in 2 patient groups

Ambu AuraGain (Group A)

Experimental group

Description:

Laryngeal mask Ambu AuraGain will be used, and oropharyngeal leak pressure (OLP) after insertion will be recorded as the primary outcome measure

Treatment:

Device: Ambu AuraGain

LMA Supreme (Group S)

Active Comparator group

Description:

Laryngeal mask Supreme will be used, and oropharyngeal leak pressure (OLP) after insertion will be recorded as the primary outcome measure

Treatment:

Device: LMA Supreme