A research to evaluate and compare two medical devices (Air-Q Blocker and ProSeal Laryngeal Mask Airway), used to ventilate patients undergoing general surgery.

Phase 4

• Registration Number: CTRI/2016/04/006833
• 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

The following patients will be included in the study

1.Age group between 18 to 60 years

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

3.Patients scheduled for elective surgery under general anaesthesia (Duration of surgery 2 ± 0.5 hrs)

Exclusion Criteria

The following patients will be excluded from the study

1.Patients with anticipated difficult airway (Airway Difficulty Score >8) 25

2.Patients with upper respiratory tract infection

3.Patients with increased risk of regurgitation and aspiration of gastric content

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

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

6.Patients undergoing surgeries involving neck and oral cavity

7.Pregnant patients

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the oropharyngeal leak pressure of Air-Q Blocker and ProSeal laryngeal mask airway in patients undergoing elective surgery under general anaesthesiaTimepoint: Immediately after the placement of device

Secondary Outcome Measures

Name	Time	Method
To evaluate the efficacy of Air-Q Blocker and comparing with ProSeal laryngeal mask airway for device insertion success, ease of gastric tube placement, fibreoptic visualization of glottis, hemodynamic and ventilatory parameters in patients undergoing elective surgery under general anaesthesiaTimepoint: 1. Ease of device insertion, ease of gastric tube placement and fibreoptic visualisation- will be observed immediately after the placement of device. <br/ ><br>2.Hemodynamic and ventilatory parameters- will be recorded at the time points- Baseline, after induction, just after device insertion and at 5, 10 and 15 minutes.