Comparison of two airway devices in adult patients undergoing elective surgery under general anaesthesia

Not yet recruiting

Conditions: Medical and Surgical,

Registration Number: CTRI/2022/12/047909

Lead Sponsor: Vardhman Mahavir Medical College and Safdarjung Hospital

Brief Summary: The supraglottic airway device is commonly used for airway management during anaesthesia or as an immediate life saving measurement in patients with difficult or failed airway. The laryngeal mask protector(LMA Protector) is a new second generation supraglottic airway device made with medical grade silicon. The LMA protector provides access tp and functional separation of the ventilation and digestive tract, with the presence of two drainage channels, which emerge proximally as separate ports and enter the chamber located behind th cuff bowl. Ambu AuraGain is a well established second generation supraglottic airway device. It has noninflatable gel like cuff made up of medical grade thermoplastic elastomer and designed to anatomically fit the peri laryngeal structures to provide effective seal.

This study will compare LMA Protector and Ambu AuraGain, mainly on the basis of the oropharyngeal leak pressure, also compares other parameters during the insertion of these devices.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 100

Inclusion Criteria

This study will be conducted in adult patients , in age group 18 to 65 years, weighing 30 to 70 kg, ASA physical status I and II undergoing elective surgery under general anaesthesia with controlled ventilation in supine position.

Exclusion Criteria

1)Patients with anticipated difficult airway 2)Mouth opening less than 3.5cm, BMI more than 30kg/m2 3)Cervical spine pathology 4)Intestinal and oesophageal pathology 5)Operation time greater than 4 hours 6)High risk of aspiration 7)Cardiac and pulmonary compromise, Hypertension 8)Poor dentition with high risk of damage 9)Pregnancy.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Oropharyngeal leak pressure	after device insertion

Secondary Outcome Measures

Name	Time	Method
Number of attempts taken for successful insertion of device, Time for achieving effective ventilation, Number of patients requiring manipulation for achieving effective ventilation and type of manipulation, Ease of insertion of device, Ease of gastric catheter insertion, Score regarding anatomical alignment of device	At the time of device insertion.

Trial Locations

Locations (1): Safdarjung hospital and Vardhman Mahavir Medical College
🇮🇳
Delhi, DELHI, India
Safdarjung hospital and Vardhman Mahavir Medical College
🇮🇳Delhi, DELHI, India
DR ASWATHI S ANAND
Principal investigator
08590449334
aswathianjanam@yahoo.com