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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

170 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2017-05-09

Brief Summary

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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.

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Detailed Description

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Conditions

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Laryngeal Masks

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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

Group Type EXPERIMENTAL

Ambu AuraGain

Intervention Type DEVICE

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

Group Type ACTIVE_COMPARATOR

LMA Supreme

Intervention Type DEVICE

Interventions

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Ambu AuraGain

Intervention Type DEVICE

LMA Supreme

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No