A clinical trial to study two devices, Proseal LMA and I-gel when used during surgery in children under anaesthesia

Comparison of Proseal LMA with I-gel in children under controlled Ventilation

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/03/012287

Enrollment

Registered

2018-03-01

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- Healthy children without any comorbidities undergoing surgery

Interventions

Intervention1: Proseal LMA: Proseal LMA sizes 2 & 2.5 will be inserted by a standard technique as prescribed by the manufacturer of the device Control Intervention1: I-gel: I-gel sizes 2 & 2.5 will be

Eligibility

Inclusion criteria

Inclusion criteria: 1)Children weighing between 10-30kgs 2)American Society of Anaesthesiologists (ASA) Grade I and II 3)Duration of surgery <2hrs

Exclusion criteria

Exclusion criteria: 1)Anticipated difficult airway. 2)History of obstructive sleep apnoea. 3)Risk of aspiration of gastric contents. 4)Laproscopic surgeries. 5)Prone position. 6)Intraoral surgeries.

Design outcomes

Primary

Measure	Time frame
compare the two devices in terms of oropharyngeal sealing pressure under controlled ventilation in childrenTimepoint: Oropharyngeal sealing pressure will be assessed immediately after insertion of the device	—

Secondary

Measure	Time frame
Success rate, insertion time, ease of insertion, fibreoptic-laryngeal view and ability to pass gastric tube of Proseal LMA and i-gelTimepoint: Immediately after insertion of the device	—

Countries

India

Contacts

Public ContactTejesh C A

MS Ramaiah Medical College

drtejeshca@yahoo.com

Outcome results

None listed

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