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.

Comparison of clinical efficacy of i-gel with ambu auragain and laryngeal mask airway prosealfor ventilation in paediatric patients undergoing elective surgery under general anaesthesia - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/10/059077

Enrollment

120

Registered

2023-10-25

Start date

Unknown

Completion date

Unknown

Last updated

2023-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: NIL: NIL Control Intervention1: i-gel,Laryngeal mask airway proseal,Ambu Auragain: i-gel is being compared with laryngeal mask airway proseal and ambu auragain in terms of oropharyngeal

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

Measure	Time frame
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 2.Anatomical alignment of device to glottic opening by Brimacombe score 3.Leak percentage 4.Intraoperative and postoperative adverse eventsTimepoint: 1.At the time of insertion 2.Durind device insertion 3.Just after insertion of device 4.1 minute,3 minutes,5 minute,15 minutes,30 minutes after insertion. 5.Postoperative adverse effects just after surgery & at 1 hour and 4 hour after surgery	—

Measure

Time frame

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 2.Anatomical alignment of device to glottic opening by Brimacombe score 3.Leak percentage 4.Intraoperative and postoperative adverse eventsTimepoint: 1.At the time of insertion 2.Durind device insertion 3.Just after insertion of device 4.1 minute,3 minutes,5 minute,15 minutes,30 minutes after insertion. 5.Postoperative adverse effects just after surgery & at 1 hour and 4 hour after surgery

—

Countries

India

Contacts

Public ContactNidhi Agrawal

Vardhman mahavir medical college and Safdarjung hospital

nidhi.agrawal1970@gmail.com9811030408

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026