Health Condition 1: O- Medical and Surgical
Conditions
Interventions
Intervention1: LMA PROSEAL DEVICE: LMA Proseal is an established supraglottic airway device that will be used during surgery. Oropharyngeal leak pressure and other secondary outcomes will be measured.
Sponsors
Sanjay Gandhi Postgraduate Institute Of Medical Sciences
Eligibility
Inclusion criteria
Inclusion criteria: 1)ASA I and II patients. 2)Both male and female patients between 1-12 years of age. 3)Elective procedures under General Anaesthesia.
Exclusion criteria
Exclusion criteria: 1.Parents/Patients attendant not giving consent. 2.Weight less than 5 kg. 3.Patients with BMI > 30 kg/m2. 4.History of recent upper respiratory tract infection. 5.Inadequate fasting. 6.Patients with contraindications to SAD (restricted mouth opening, upper airway obstruction etc.). 7.Patients with abnormal/distorted anatomy of the upper airway. 8.Head, neck and oral surgery. 9.Patients with increased risk of aspiration (GERD, Hiatus Hernia etc.). 10.Emergency surgeries.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Oropharyngeal Leak Pressure will be measured as the primary outcome.Timepoint: Immediately after supraglottic airway device insertion. | — |
Secondary
| Measure | Time frame |
|---|---|
| First-attempt and overall success rate of LMA insertion 2. Device insertion time 3. Ease of LMA insertion 4. Leak fraction calculation 5. Fibreoptic scoring of glottic opening 6. Ease of gastric tube insertion 7. Gastric tube insertion time 8. Vitals(SBP/DBP/HR/SPO2) 9. Peak airway pressure 10. Adverse effects: Bloodstain on the device, Hypoxia, Cough, Injury to lips, tongue, Oropharyngeal soft tissue and teeth, Sore throat, Change of voice,DysphagiaTimepoint: 1. before insertion of LMA(baseline) 2. From the time of touching the device and insertion till appearance of the first capnograph 3. grading ease of insertion 4. immediately after LMA insertion 5. Fibreoptic scope grading will be seen 6. gastric tube insertion will be graded 7. From touching the device till insertion and confirmation 8. At 1,5,10 and 15-minute intervals 9. At 1,5,10 and 15-minute intervals 10. Immediately and till 24hrs postoperative period | — |
Countries
India
Contacts
Public ContactDr Kolli Ajit Kumar
Sanjay Gandhi Postgraduate Institute of Medical Sciences
Outcome results
None listed