A Comparative evaluation of performance of newer cuffless supraglottic devices: GMA Tulip versus SLIPA3G:A prospective randomised study in adults patients undergoing surgery under general anaesthesia
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Pt. B.D. Sharma, PGIMS Rohtak, Haryana
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- To evaluate and compare oropharyngeal leak pressure between GMA-Tulip and SLIPA3G
Overview
Brief Summary
This study is to compare the oropharyngeal leak pressure between two supraglottic devices SLIPA3G and GMA-Tulip in 18-60year ASA I and II patients undergoing surgery under general anaesthesia. Time taken for device placement, first attempt success rate of two devices, ease of device placement, fibreoptic grade of device placement and hemodynamic variations will be studied. Data will be compiled and appropriate stastical test will be used to analyse the results.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Adult patient aged between 18 to 60 years, having ASA status I or II and patients undergoing surgery under general anaesthesia where placement of supraglottic device is indicated.
Exclusion Criteria
- •Respiratory or Pharyngeal pathology Mouth opening less than 2 cm BMI more than 30kg/m2 Pregnancy Full stomach.
Outcomes
Primary Outcomes
To evaluate and compare oropharyngeal leak pressure between GMA-Tulip and SLIPA3G
Time Frame: The performace of Two gadgets will be compared after insertion, throughout the operative procedure and removal of device. surgical period may last from one hour to 2 hours. Mean arterial pressure, Heart rate, Sp02 will be evaluated at baseline, after induction, after device placement and 5 minutes after device placement
Secondary Outcomes
- Time taken for device placement(First attempt success rate of two devices)
Investigators
Dr Kiranpreet Kaur
Pt.B.D. Sharma PGIMS Rohtak