A Randomised Comparative study to evaluate the performance of Ambu Auragain and the Laryngeal Mask Airway Supreme

Recruiting

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2023/07/055390
• Lead Sponsor: JJM Medical College

Brief Summary

Supraglottic Airway devices form a bridge between the mask and endotracheal intubation. Following the introduction of LMA , numerous advances have been made with respect to design and safety features. The LMA Supreme and Ambu Auragain are the new second generation SGADs having comparable features such as inflatable cuff, a preformed anatomical curvature facilitating easy insertion and a gastric port for Nasogastric tube insertion and produces high OLP facilitating positive pressure ventilation. Previous studies have reported conflicting results regarding performance of these 2 devices. We are conducting this study to compare insertion of the device, OLP, ease of NGT insertion, hemodynamic stability and complications.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-08
• Last Update Posted: 2024-02-20

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Duration of surgeries less than 2 hours ASA I and II Posted for elective surgery under general anaesthesia in supine position.

Exclusion Criteria

Patients with predicted difficult airway Patients with any pathology in neck, upper respiratory or alimentary tract BMI more than 30kg/me Patients with history of obstructive sleep apnea,lung diseases or bleeding disorders Patients with full stomach or history of oesophageal reflux Pregnancy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Oropharyngeal leak pressure(in cm H2O)	Hemodynamic changes(heart rate, saturation and blood pressure)at 1min, 5min and 10 min after Supraglottic Airway Device insertion
Ease of insertion of Nasogastric tube	Hemodynamic changes(heart rate, saturation and blood pressure)at 1min, 5min and 10 min after Supraglottic Airway Device insertion
Number of attempts, time taken for insertion(in seconds) and ease of insertion	Hemodynamic changes(heart rate, saturation and blood pressure)at 1min, 5min and 10 min after Supraglottic Airway Device insertion
Hemodynamic changes(heart rate, saturation and blood pressure)	Hemodynamic changes(heart rate, saturation and blood pressure)at 1min, 5min and 10 min after Supraglottic Airway Device insertion

Secondary Outcome Measures

Name	Time	Method
Intraoperative desaturation or laryngospasm	Blood stain on device during withdrawal

Trial Locations

Locations (1)

Bapuji hospital; 🇮🇳 Davanagere, KARNATAKA, India

Bapuji hospital

🇮🇳Davanagere, KARNATAKA, India

JSAnmol

Principal investigator

8197123168

jsanmolpatel@gmail.com