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Comparison of two supraglottic airway devices in children

Comparative evaluation of clinical efficacy of inflatable cuffed with non inflatable cuffed supraglottic airway devices for ventilation in paediatric patients undergoing elective surgery under general anaesthesia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/08/027440
Enrollment
80
Registered
2020-08-28
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: - Health Condition 2: O- Medical and Surgical

Interventions

Intervention1: AmbuAuraGain: In group A ,a lubricated ambuauragain of appropriate size will be inserted after fully deflating the cuff .After inserting cuff of ambuauragain will be inflated with air t

Sponsors

Vardhman Mahavir Medical College and Safdarjung HospitalNew Delhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: The study will be conducted in the age group of 2 to 10 years weighing 10 to 30kg ,fulfilling the criteria of American society of Anesthesiologist (ASA) Physical status I and II and undergoing elective surgical procedures under general anaesthesia with controlled ventilation

Exclusion criteria

Exclusion criteria: Patients with difficult airway Anticipated operation time greater than 4 hours High risk of aspiration Pre operative respiratory tract infections

Design outcomes

Primary

MeasureTime frame
Oropharyngeal seal pressureTimepoint: Within five minutes and at ten minutes post device insertion

Secondary

MeasureTime frame
Insertion characteristics Anatomical alignment of device to glottis opening by Brimacombe score Leak percent Intraoperative and postoperative adverse eventsTimepoint: Intraoperative and postoperative periods

Countries

India

Contacts

Public ContactVarsha Jakhar

Vardhman Mahavir Medical College and Safdarjung Hospital,New Delhi

nidhi.agrawal1970@gmail.com9811030408

Outcome results

None listed

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