CTRI/2025/11/097055Not yet recruitingNot Applicable
A Randomised comparative Study to evaluate oropharyngeal leak pressure of Self – pressurized Air-Q versus I-Gel Laryngeal Airway in pediatrict patients under general anaesthesia at SMS Medical College Jaipur
SMS MEDICAL COLLEGE AND ATTACHED HOSPITAL, JAIPUR1 site in 1 country70 target enrollmentStarted: November 15, 2025Last updated:
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Oropharyngeal leak pressure of Self -pressurised Air-Q and I-Gel laryngeal airway measured in paediatric patients under general anaesthesia
Study Overview
Brief Summary
A Randomised Study to compare oropharyngeal leak pressure of I-Gel v/s Self – pressurized Air-Q Laryngeal Airway in pediatric patients under general anaesthesia,To find out the effectiveness of supraglottic Airway device Air-Q SP and I-Gel in terms of oropharyngeal leak pressure in pediatric surgical patients under general anaesthesia.
Study Design
- Study Type
- Interventional
- Allocation
- Other
- Masking
- Participant Blinded
Eligibility Criteria
- Ages
- 0.00 Day(s) to 5.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Parent/guardian willing to provide consent for participation.
- •Patients of either sex.
- •age 0-5 years weight -0-25 kg ASA GRADE I and II Undergoing elective surgery in supine position requiring general anaesthesia.
Exclusion Criteria
- •Abnormal airway anatomy assessed by – inadequate mouth opening, micrognathia, thyromental distance, and submental compliance, intra oral growth.
- •Patient with cardiopulmonary disease Severe gastrointestinal reflux History of upper respiratory tract infection in previous 14 days.
- •Syndromic children with difficult airway, intraoral pathology.
Outcomes
Primary Outcomes
Oropharyngeal leak pressure of Self -pressurised Air-Q and I-Gel laryngeal airway measured in paediatric patients under general anaesthesia
Time Frame: 1.Immediately after insertion of the device | 2.After 5 minutes post insertion | 3.At the end of surgery befor device removal
Secondary Outcomes
- To evaluate and compare fiber optic view of larynx between two study groups.(To evaluate and compare post-operative complications (laryngospasm, sore throat, dysphagia, blood staining of device) between two study groups.)
Investigators
Dr Neelam Dogra
SMS MEDICAL COLLEGE, JAIPUR
Study Sites (1)
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