Comparison of two different supraglottic airway devices for securing an artificially created difficult airway in patients undergoing elective surgery.
Phase 4
Completed
- Conditions
- Health Condition 1: null- Age 18 to 65 yearsASA Grade I and IINormal airway
- Registration Number
- CTRI/2018/10/015901
- Lead Sponsor
- Vardhman Mahavir Medical College And Safdarjung Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 180
Inclusion Criteria
1)ASA grade I and II
2)Normal airway
3)Weight 30 to 70 kg
Exclusion Criteria
1)Weight less than 30kg
2)BMI more than 30kg/m2
3)Anticipated difficult airway
4)Mouth opening less than 4cm
5)Cervical spine pathology
6)Intestinal and oesophageal pathology
7)Operation time more than 4hrs
8)High risk of aspiration
9)Preoperative sore throat
10)Poor dentition with high risk of damage
11)Pregnancy
12)Impossible face mask ventilation with extrication collar in place
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate and compare efficacy of LMA-supreme and i-gel in patients with simulated difficult airway with respect to total <br/ ><br>time for successful insertion. <br/ ><br>Timepoint: At the time of intubation.
- Secondary Outcome Measures
Name Time Method 1)Manipulations for effective ventilation <br/ ><br>2)No. of attempts taken <br/ ><br>3)Reasons for failure of attempts <br/ ><br>4)Gastric tube insertion <br/ ><br>5)Oropharyngeal leak pressure <br/ ><br>6)Score regarding anatomical alignment of device <br/ ><br>7)Haemodynamic changes <br/ ><br>8)Intraoperative and postoperative adverse events <br/ ><br>9)Postoperative pharyngolaryngeal morbidityTimepoint: At the time of intubation, during the surgery and post operative period.