A clinical trial to study the efficacy of three airway devices,i-gel ,Ambu Auragain and laryngeal mask airway proseal in children undergoing elective surgery under general anaesthesia.

Phase 4

• Conditions: Health Condition 1: O- Medical and Surgical

• Registration Number: CTRI/2023/10/059077
• Lead Sponsor: vmmc and safdarjung hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 13 November 2023

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

120 children in age group of 1 to 10 yaers,weighing 6kg to 30kg, fulfilling American Society of Anaesthesiologists[ASA] Physical status I and II and undergoing elective surgery under general anaesthesia with controlled ventilation.

Exclusion Criteria

Patients with anticipated difficult airway, Anticipated duration of surgery greater than 4 hours, High risk of aspiration

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
oropharyngeal seal pressure will be noted within 5 minutes after device insertion for all three devices with intracuff pressure of ambu auragain & LMA Proseal adjusted to 40cm of water. Another reading of oropharyngeal seal pressure at intracuff pressure of 40cm of water will be taken after 30 minutes of device insertipon. Oropharyngeal seal pressure will be measured with intracuff pressure of Ambu auragain & LMA Proseal at 60 cm of water also within 5 minutesof device insertion.Timepoint: 5 minutes after device insertion for all three devices, after 30 minutes of device insertipon for all three devices

Secondary Outcome Measures

Name	Time	Method
1.Insertion characteristics- number of attempts taken for successful insertion of device, time for achieving effective ventilation,number of patients requiring manipulation for achieving effective ventilation & type of manipulation, ease of insertion of device,ease of gastric catheter insertion <br/ ><br>2.Anatomical alignment of device to glottic opening by Brimacombe score <br/ ><br>3.Leak percentage <br/ ><br>4.Intraoperative and postoperative adverse eventsTimepoint: 1.At the time of insertion <br/ ><br>2.Durind device insertion <br/ ><br>3.Just after insertion of device <br/ ><br>4.1 minute,3 minutes,5 minute,15 minutes,30 minutes after insertion. <br/ ><br>5.Postoperative adverse effects just after surgery & at 1 hour and 4 hour after surgery