To Compare Between Two Supraglottic Airway Devices in Anaesthetised, Paralysed Patients

Not yet recruiting

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2021/12/038687
• Lead Sponsor: Maulana Azad Medical College

Brief Summary

Laryngeal Mask Airway Protector is latest second generation airway device introduced in 2015 combining pharyngeal chamber and dual gastric drainage channels. There is paucity of studies which compared LMA Protector to other supraglottic airway device. The present study is proposed to compare the performance of LMA Protector to LMA Proseal in 250 patients undergoing elective surgeries under anaesthesia. Adult patients aging 18- 65 years of either sex and those belonging to ASA PS I and II who was scheduled to undergo elective surgeries under general anaesthesia with supraglottic device will be recruited for participation in study. Pregnant patients those having BMI >35  kg/m2 and patients at increased risk of aspiration will be excluded. Patients will be randomly allocated into 2 groups ; in group 1 ( LMA Protector group) in group 2 ( LMA Proseal).Standard technique of anaesthesia will be used in both groups. As per group allocation either LMA Protector or LMA Proseal will be used for securing airway of patients. 3 attempts will be allowed for successful placement in either groups. Primary objective will be time taken for successful insertion of LMA Protector and LMA Proseal. Secondary objectives will be ; to compare number of attempts for successful insertion; to compare the ease of insertion of nasogastric tubes through LMA Protector and LMA Proseal; to see correct placement by fibreoptic evaluation. Collected data will be entered in Microsoft excel and then will be analysed and statistically evaluated using SPSS-25.0 version. Appropriate statistical tests will be applied.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2021-12-15
• Study Start: 2021-12-25

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

• 1. Age 18 to 65 years of either sex.
• 2. American Society Of Anaesthesiologists(ASA) Class 1 and 2.

Exclusion Criteria

• 1. Patients at increased Risk of Aspiration or GERD.
• 2. BMI >35kg/m2 3) Pregnancy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Insertion Time	At Baseline

Secondary Outcome Measures

Name	Time	Method
1.Number of attempts	2.Ease of gastric tube placement

Trial Locations

Locations (1)

Lok Nayak Hospital; 🇮🇳 Central, DELHI, India

Lok Nayak Hospital

🇮🇳Central, DELHI, India

Dr Garima

Principal investigator

7578284722

garima.bhatt.25.10.93@gmail.com