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Comparison of two airway devices in paediatric patients undergoing elective surgery under general anaesthesia

Comparison of clinical efficacy of newer single use versus conventional multiple use supraglottic airway devices in paediatric patients undergoing elective surgery under general anaesthesia

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/04/018844
Enrollment
100
Registered
2019-04-30
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: R69- Illness, unspecified

Interventions

Intervention1: Ambu AuraGain: Patient in this group will be given general anaesthesia with inhalation of sevoflurane up to 8%,Inj fentanyl 2 microgram/kg IV, inj vecuronium 0.1mg/kg.After induction pa

Sponsors

VARDHMAN MAHAVIR MEDICAL COLLEGE AND SAFDARJUNG HOSPITAL NEW DELHI
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Paediatric patients in age group 1 to 12 years, ASA GRADE I AND II, weighing 5 to 30 kg and undergoing elective surgical procedures.

Exclusion criteria

Exclusion criteria: 1)Patients with anticipated difficult airway and cervical spine pathology, 2)Anticipated operation time greater than 4 hours, 3) High risk of aspiration (gastroesophageal reflux), 4) Preoperative respiratory tract infection.

Design outcomes

Primary

MeasureTime frame
Comparing oropharyngeal seal pressure of Ambu AuraGain with LMA ProSealTimepoint: At the time of intubation

Secondary

MeasureTime frame
Number of attempts for insertion,time taken,ease,anatomical alignment of the device to glottic opening by fibre optic scoring,occurance of sore throat and dysphagiaTimepoint: At the time of intubation,during surgery And post operative period

Countries

India

Contacts

Public ContactDR NIDHI 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