To compare the placement of a Second generation supra-glottic airway device using the introducer tool and stylet in a neutral head position in adults under general anaesthesia.

Not yet recruiting

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2020/09/027523
• Lead Sponsor: Atal Bihari Vajpayee Institute Of Medical Sciences and DrRam Manohar Lohia

Brief Summary

This study is a randomised comparative study comparing the Proseal Laryngeal mask airway (PLMA) placement using the Introducer tool and Stylet in neutral head position in 60 adults (30 patients in each group)under general anaesthesia.It will be conducted at Atal Bihari Vajpayee Institute of Medical Sciences and Dr.Ram Manohar Lohia Hospital,New Delhi,India.

The primary outcome measures the placement of the PLMA using a scoring within 2 years. The secondary outcome will measure the first attempt success rate,number of insertion attempts,total time to successful insertion and the haemodynamic response to insertion within a period of 2 years.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-05-09
• Last Update Posted: 2020-08-27

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• ASA status I and II.
• Elective surgery under general aneasthesia using proseal laryngeal mask airway.

Exclusion Criteria

• Anticipated difficult airway(Mallampati grade greater than equal to grade III,thyromental distnace less than 6cm.) Mouth opening less than 2.5cm.
• BMI greater than equal to 35kg/metre sqaure.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assessment of Proseal laryngeal mask airway palcement using Brimacombe fibre-optic scoring system	no post-op follow up

Secondary Outcome Measures

Name	Time	Method
First attempt success rate of Proseal laryngeal mask airway(PLMA) insertion.	Number of insertion attempts.

Trial Locations

Locations (1)

Atal Bihari Vajpayee Institute of Medical Sciences and Dr. Ram Manohar Lohia Hospital; 🇮🇳 Delhi, DELHI, India

Atal Bihari Vajpayee Institute of Medical Sciences and Dr. Ram Manohar Lohia Hospital

🇮🇳Delhi, DELHI, India

Dr Dasara Nongbet

Principal investigator

07896847410

dasara.nongbet@gmail.com