A research to evaluate and compare two medical devices (Ambu Aura Gain and Proseal Laryngeal Mask airway), used to ventilate patients undergoing general surgery.

Phase 4

• Registration Number: CTRI/2015/07/005965
• Lead Sponsor: Government medical college

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 90

Inclusion Criteria

Inclusion criteria

1. Age group b/w 20 to 60 years

2. American Society of Anaesthesiologist (ASA) physical status I and II, and

3. Patients scheduled for elective surgery under general anaesthesia

Exclusion Criteria

The following patients will be excluded from the study.

1. Patients with known or predicted difficult airway or Mallampati Grade (MPG) III/IV

2. Patients with mouth opening of less than 2.5 cm.

3. Patients with upper respiratory tract infection.

4. Patients with increased risk of regurgitation and aspiration (emergency surgeries and non-fasting patients).

5. Patients with a body mass index (BMI) > 35 kg.m.-2

6. Patients with past history of radiotherapy to the neck involving the hypopharynx.

7. Patients with expected duration of surgery of more than 2 hours.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the oropharyngeal leak pressure (OLP) of Ambu AuraGain laryngeal mask and Proseal laryngeal mask airwayin patients undergoing elective surgery under general anaesthesia.Timepoint: immediately after the placement of the device.

Secondary Outcome Measures

Name	Time	Method
To compare the overall efficacy of Ambu AuraGain and Proseal laryngeal mask airway by comparing the ease of insertion of device, ease of gastric tube placement, fibreoptic visualization, hemodynamic and ventilatory parameters, in patients undergoing elective surgery under general anaesthesia.Timepoint: 1. Ease of insertion of device, ease of gastric tube placement and fibreoptic visualization - will be observed immediately after the placement of device. <br/ ><br>2. Hemodynamic and ventilatory parameters - every minute till 15 minutes after the placement of device.