Comparing Insertion Of ProSeal Airway Device With Introducer Tool With Stylet And Without Stylet
- Conditions
- Paediatric patients posted for elective surgery under General Anaesthesia
- Registration Number
- CTRI/2022/11/047791
- Lead Sponsor
- Dr. NAMITA ARORA
- Brief Summary
Patients, who fulfill the inclusion criteria, will participate in the study. They will be computerised randomisation where they will be divided into two groups IT - 65 patients and ST - 65 patients.
In IT group, the PLMA will be inserted with an introducer tool, followed by clinical assessment and assessment by fibreoptic bronchoscope.
In ST group, the PLMA will be inserted using a stylet, followed by clinical assessment and assessment with fibreoptic bronchoscope.
Based on a five-point scale by CHen et al, grading of glottic view on fibreoptic bronchoscopy will be done.
Grade and 4 are acceptable placement, whereas grades 0,1,2 are not acceptable and require endotracheal tube intubation.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 130
- ASA Status I and II 2.
- Elective Surgery under General Anaesthesia.
- Anticipated Difficult Airway 2.
- Airway related surgery, posttonsillectomy 3.
- Emergency Surgery 4.
- Children with cardio-respiratory disease, URTI, Hiatus Hernia, Full stomach, History of convulsions.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Fibreoptic Bronchoscopic grading of PLMA placement Realtime
- Secondary Outcome Measures
Name Time Method 1. Number of attempts for insertion 2. Total time taken for successful insertion(seconds)
Trial Locations
- Locations (1)
ABVIMS And Dr. Ram Manohar Lohia Hospital
🇮🇳Delhi, DELHI, India
ABVIMS And Dr. Ram Manohar Lohia Hospital🇮🇳Delhi, DELHI, IndiaDr Neha PandeyPrincipal investigator9205415492neehapaandey26@gmail.com