To compare two types of airway devices proseal LMA and i-gel in children undergoing elective surgical procedures
Phase 3
- Registration Number
- CTRI/2023/07/055505
- Lead Sponsor
- Anisha Pauline
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1) ASA grade I and II.
2) Children of either sex aged 1-10 years
3) BMI <30
4) Mouth opening of more than 2.5cm.
5) Elective lower abdominal, minor urological and minororthopaedic surgeries of duration less than 120minutes, such as circumcision, orchidopexy, herniotomy, urethroplasty,implant exit in upper limb and lower limb
Exclusion Criteria
1)Parent/Guardian refusal
2)Patients with active upper/lower respiratory tract
infections.
3) Patients at risk of aspiration.
4) Patients with known systemic or syndromic comorbidities.
5) Patients with airway abnormalities, loose teeth.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Oropharyngeal leak pressure & successful placement meeting all 5 criteria of <br/ ><br>tidal volumes more than 6 ml per kg <br/ ><br>bilateral equal chest rise <br/ ><br>EtCO2 waveform of 30 to 35 mmHg <br/ ><br>no peak pressure elevation more than 30 cm H2O <br/ ><br>with no audible leakTimepoint: Within 10 minutes of jntubation
- Secondary Outcome Measures
Name Time Method Ease of insertion <br/ ><br>Ease of gastric tube placement <br/ ><br>Incidence of larngospasm <br/ ><br>Incidence of Bloodstained LMA after extubation <br/ ><br>Incidence of sorethroat,hoarse cry,or any other discomfort in throat postoperativelyTimepoint: Intraoperative & postoperative period