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

Study Overview
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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.

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

Conditions
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Laryngeal Masks

Intervention / Treatment
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* Device: Ambu AuraGain
* Device: LMA Supreme


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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) |