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A RESEARCH STUDY TO ASSESS FEASIBILITY OF ADMINISTERING TWO DIFFERENT VENTILATOR MODES FOR LIBERATION FROM VENTILATOR IN HIGH RISK CHILDREN

Continuous positive airway pressure versus pressure support for predicting successful liberation from invasive ventilation in children with high risk for extubation failure – a pilot randomized controlled trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/11/059777
Enrollment
80
Registered
2023-11-14
Start date
Unknown
Completion date
Unknown
Last updated
2023-12-19

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

Conditions

Health Condition 1: J00-J99- Diseases of the respiratory system

Interventions

Intervention1: Pressure support: Child will receive 8- 10cm H2O in addition to PEEP of 5-6cm H2O for duration of 2 hours Control Intervention1: CPAP: Child will receive 5-6cm of H2O PEEP without addit

Sponsors

POSTGRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Invasively ventilated children ( > 48h) with one or more of the following criteria for high risk for extubation failure. 1. Age less than 1 year 2. Mechanical ventilation for > 14 days 3. Severe ARDS 4. Genetic syndromes 5. Pre-existing chronic lung disease or home O2/BiPAP therapy 6. Children with uncorrected congenital heart disease 7. Previous failed SBT or failed extubation or unplanned extubation 8. Evidence of myocardial dysfunction [Ejection fraction 5% 10. Severe acute malnutrition 11. Neurological impairment and/or neuromuscular weakness [Primary or ICU acquired]

Exclusion criteria

Exclusion criteria: 1. Short-term/ procedural intubation 2. End of life care

Design outcomes

Primary

MeasureTime frame
FEASIBILITY OUTCOMES 1. Recruitment rate Proportion of enrolled children among total eligible children. 2. Protocol compliance a. Time from randomization to initiation of SBT b. Adherence to SBT method and duration c. Time from SBT success to extubationTimepoint: 1. 14 months 2. Time period from randomization till discharge from PICU—

Secondary

MeasureTime frame
SECONDARY OUTCOMES A.First SBT success rate B.Successful extubation after first SBT C.Need for post extubation NIV D.Length of PICU stay Timepoint: A.At 2 hours of SBT B.72 hours post extubation C.72 hours post extubation D.Discharge from PICU /28 days—

Countries

India

Contacts

Public ContactDr Karthi Nallasamy

PGIMER

ny.karthi@gmail.com9814376716

Outcome results

None listed

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