Comparison of on ground performance of three airways devices – I-gel, LMA Supreme, Ambu AuraGain in side-up position in children undergoing surgery under complete (general) anaesthesia

A randomised study comparing the clinical performance of three disposable supraglottic airway devices-I-gel, LMA Supreme and Ambu AuraGain in lateral position in pediatric patients undergoing surgery under general anesthesia. - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/03/064760

Enrollment

108

Registered

2024-03-26

Start date

Unknown

Completion date

Unknown

Last updated

2024-04-01

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: Ambu AuraGain and LMA Supreme: After insertion of the above devices under general anaesthesia, oropharyngeal seal pressure will be measured by equilibrium airway pressure method in supi

Eligibility

Inclusion criteria

Inclusion criteria: 1 ASA I and II 2 Patients undergoing elective day care under general anaesthesia in which the choice of airway device has already been decided as a disposable second generation supraglottic airway device and who require lateral position intraoperatively 3 Weight more than 10 kgs up to 25-35 kgs

Exclusion criteria

Exclusion criteria: 1.Difficult airway. 2.Active Upper respiratory tract infection (URTI) 3.Alimentary tract pathology 4.Cervical spine pathology Anticipated 5.Raised Intra-abdominal pressure.

Design outcomes

Primary

Measure	Time frame
Oropharyngeal seal pressures (cm H20) of Ambu AuraGain, LMA supreme, I-gel in lateral position using equilibrium airway pressure method, measured by reading (centimetres of H2O) displayed on ventilator screen (Drager Primus);Timepoint: Oropharyngeal seal pressures (cm H20) of Ambu AuraGain, LMA supreme, I-gel in lateral position using equilibrium airway pressure method, measured by reading (centimetres of H2O) displayed on ventilator screen (Drager Primus). The OSP will be checked at 10 mins after insertion , 1st minute after lateralisation, 5th minute after lateralisation	—

Measure

Time frame

Oropharyngeal seal pressures (cm H20) of Ambu AuraGain, LMA supreme, I-gel in lateral position using equilibrium airway pressure method, measured by reading (centimetres of H2O) displayed on ventilator screen (Drager Primus);Timepoint: Oropharyngeal seal pressures (cm H20) of Ambu AuraGain, LMA supreme, I-gel in lateral position using equilibrium airway pressure method, measured by reading (centimetres of H2O) displayed on ventilator screen (Drager Primus). The OSP will be checked at 10 mins after insertion , 1st minute after lateralisation, 5th minute after lateralisation

—

Secondary

Measure	Time frame
1. To determine the OSP of the mentioned devices in supine position after 10 mins of insertion of the airway device 2.Time taken and number of attempts for insertion 3. Device failure rate 4. Need for airway manoeuvres 5. Fractional volume loss 6. Post operative sorethroat, hoarsenessTimepoint: Baseline, 10 mins, post op 1st hr, 6th hr, 24th hr	—

Countries

India

Contacts

Public ContactDr Zainab Ahmad

All India Institute Of Medical Sciences, Bhopal

drzainabhaq@gmail.com8860048951

Outcome results

None listed

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