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Study to Compare the Type of Pressure Selection using predesigned table(LOW-PEEP/HIGH-FIO2 table )with Conventional method in Machine Assisted Breathing in children with severe acute lung injury.

Randomized Control Trial Comparing the Effect of PEEP Titration using LOW-PEEP/HIGH-FIO2 Table with Conventional Method of PEEP titration in Pediatric Acute Respiratory Distress Syndrome. - NIL

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/03/063498
Enrollment
60
Registered
2024-03-04
Start date
Unknown
Completion date
Unknown
Last updated
2024-12-09

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

Conditions

Health Condition 1: J80- Acute respiratory distress syndrome

Interventions

Intervention1: Low PEEP/High FiO2 table from ARDSnet: Optimization of PEEP based on pre-designed table given by ARDSnet in the management of ARDS in children. Control Intervention1: Conventional PEEP

Sponsors

Rainbow Childrens Medicare Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Invasively ventilated children more than 1 month and up to 18 years age with pARDS diagnosed as per PALICC-2

Exclusion criteria

Exclusion criteria: 1. Children who are not intubated 2. Children who are already on High Frequency Oscillatory ventilation. 3. Children with open chest (following surgery) 4. Children with raised Intra cranial pressure 5. children with post cardiac arrest, neuromuscular disorder, congenital heart disease, mechanical ventilation of more than 1-week, uncontrolled terminal illness, 6. Previous barotrauma (pneumothorax, pneumomediastinum or subcutaneous emphysema) 7. When treating consultant refuses to participate (Due to unacceptable Vt, hemodynamic instability, radiological/ clinical evidence of lung hyperinflation)

Design outcomes

Primary

MeasureTime frame
To assess the changes in oxygenation index at the end of 48 hrsTimepoint: To assess the changes in oxygenation index at the end of 48 hrs—

Secondary

MeasureTime frame
28-Day ventilation Free days and Mortality difference between the groups.Timepoint: 28 days;28-Day ventilation Free days and Mortality difference between the groups. • 28- day ventilator free days, • 28-day mortality, • 90 days mortality, • Incidence of air leak, • length of PICU stay, • length of hospital stay • Organ failure free days.Timepoint: 28 days;28-Day ventilation Free days and Mortality difference between the groups. • 28- day ventilator free days, • 28-day mortality, • 90 days mortality, • Incidence of air leak, • length of PICU stay, • length of hospital stay • Organ failure free days.Timepoint: 28 days—

Countries

India

Contacts

Public ContactDr Latha

Rainbow Childrens Hospital

drfarhan@rainbowhospitals.in9866007602

Outcome results

None listed

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