A research to evaluate and compare two airway management devices (Baska airway and Proseal laryngeal mask airway)in patients undergoing general surgery.

Phase 4

Not yet recruiting

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2019/04/018843
• Lead Sponsor: Government Medical College and Hospital

Brief Summary

This study is a prospective, randomised, parallel group, active control trial where two devices Baska airway and Proseal laryngel mask airway, used for maintainence of airway during general anaesthesia , will be compared primarily in terms of differences in there respiratory indexes. Secondary outcome measured will compare the ease of insertion of two LMA’s, oropharyngeal leak pressure, hemodynamic parameters and post operative complications, in patients undergoing surgery under general anaesthesia.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-05
• Last Update Posted: 2019-04-29

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

• The following patients would be included for 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 would not be included for the study: 1.
• Patients with anticipated difficult airway (ADS >8).
• Patients with upper respiratory tract infection 3.
• Patients with increased risk of regurgitation and aspiration of gastric content.
• Patients with a body mass index (BMI) > 35 kg.m2 5.
• Patients with history of radiotherapy to the neck involving the hypopharynx.
• Pregnant patients.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare respiratory indexes in both Baska airway and Proseal laryngeal mask airway.	Immediatly after the placement of device then every 5 mins till 15 mins and then at 30 mins after the placement of device.

Secondary Outcome Measures

Name	Time	Method
To compare ease of insertion, oropharyngeal leak pressure, hemodynamic data and postoperative complications in two groups.	1. Ease of insertion of device, ease of use of gastric tube placement and fiberoptic placement will be observed immediatly after the placement of device.

Trial Locations

Locations (1)

Governmen Medical College and Hospital, Chandigarh; 🇮🇳 Chandigarh, CHANDIGARH, India

Governmen Medical College and Hospital, Chandigarh

🇮🇳Chandigarh, CHANDIGARH, India

Dr Maninder Kaur

Principal investigator

9780462029

mkmaninder30@gmail.com