Comparison of two airway devices in adult patients undergoing elective surgery under general anaesthesia
- 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
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.
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, IndiaDR ASWATHI S ANANDPrincipal investigator08590449334aswathianjanam@yahoo.com