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Clinical Performance Comparison of LMA Supreme, LMA Proseal, and Ambu AuraGain in Pediatric Anesthesia

Comparison of the clinical performance of the LMA Supreme, LMA Proseal , and Ambu AuraGain in Paediatric Patients undergoing Elective Surgery under General Anaesthesia - NIL

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/04/084153
Enrollment
105
Registered
2025-04-04
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-28

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 Health Condition 2: J958- Other intraoperative and postprocedural complications and disorders of respiratory system, not elsewhere classified

Interventions

Intervention1: Ambu Aura Gain: For short surgical procedures (less than 2 hours) The Ambu AuraGain is a second-generation, disposable laryngeal mask designed for rapid placement, high seal pressures,

Sponsors

Dr.Nikunjkumar Bharatkumar Prajapati
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: weighing 5 to 30 kg ASA Physical Status I and II Undergoing elective surgical procedures in supine position

Exclusion criteria

Exclusion criteria: Children with active upper respiratory tract infection/cardiopulmonary disease /systemic disease Anticipated difficult airway (micrognathia, anatomical airway abnormalities or history of difficult intubation), Weight more than 30 kg, any condition that increases risk for gastrooesophageal regurgitation and aspiration (e.g.gastro-oesophageal reflux disease or gastrointestinal stenosis) Allergy to the materials Parents/guardians unwilling to participate

Design outcomes

Primary

MeasureTime frame
compare the clinical effectiveness and oral pharyngeal seal pressures between LMA ProSeal, AAG and LMA supreme in children receiving controlled ventilation.Timepoint: OLP immediately after insertion and 10 mins after insertion.

Secondary

MeasureTime frame
HAEMODYNAMIC MONITORING Pulse BP SPO2 ET CO2 Timepoint: Immediately after insertion 5 min 10 min 20min 30min 45min 60min 90 min 120min

Countries

India

Contacts

Public ContactDrVrinda Oza

P.D.U. Medical college and Hospital Rajkot

Vrinda.agravat@yahoo.com9228099479

Outcome results

None listed

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