A clinical trial to study two devices, Proseal LMA and I-gel when used during surgery in children under anaesthesia
Phase 4
Completed
- Conditions
- Health Condition 1: null- Healthy children without any comorbidities undergoing surgery
- Registration Number
- CTRI/2018/03/012287
- Lead Sponsor
- Tejesh C A
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 70
Inclusion Criteria
1)Children weighing between 10-30kgs
2)American Society of Anaesthesiologists (ASA) Grade I and II
3)Duration of surgery <2hrs
Exclusion Criteria
1)Anticipated difficult airway.
2)History of obstructive sleep apnoea.
3)Risk of aspiration of gastric contents.
4)Laproscopic surgeries.
5)Prone position.
6)Intraoral surgeries.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method compare the two devices in terms of oropharyngeal sealing pressure under controlled ventilation in childrenTimepoint: Oropharyngeal sealing pressure will be assessed immediately after insertion of the device
- Secondary Outcome Measures
Name Time Method Success rate, insertion time, ease of insertion, fibreoptic-laryngeal view and ability to pass gastric tube of Proseal LMA and i-gelTimepoint: Immediately after insertion of the device