Early vs Conventional High-Frequency Oscillatory Ventilation in Moderate and Severe Acute Respiratory Distress syndrome: An Open Labelled Randomized Superiority Controlled Trial
Overview
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Division of Pediatric Critical Care Department of Pediatrics AIIMS Raipur
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- To compare 28-day mortality outcomes between
Overview
Brief Summary
Physiologically High Frequency Oscillatory Ventilation is better than Conventional Mechanical Ventilation as constant distending pressure with low tidal volume delivery reduces Ventilator-induced lung Injury. However, this didn’t translate into clinical practice as per studies done in adults. In the pediatric population, though HFOV is used as a rescue modality of ventilation, prospective studies to see the benefit of early HFOV versus conventional ventilation followed by rescue HFOV are lacking. Most of the evidence is from post hoc secondary analysis or retrospective analysis and patient selection too isn’t uniform across studies: Few of them have just considered post-marrow transplant recipients, and few of them have included patients with diagnoses other than severe ARDS. So, we propose to investigate the benefits of early HFOV over rescue HFOV usage in case of moderate and severe ARDS defined as per PALICC 1 guidelines by doing a randomized controlled trial in our setting.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 1.00 Month(s) to 14.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Children aged 1 month to 14 years admitted in PICU, with moderate and severe ARDS classified as per PALICC 1 guidelines.
Exclusion Criteria
- •History of interstitial lung disease
- •Chronic renal failure
- •Central nervous system involvement: Especially raised intracranial pressure
- •Immunodeficient patients including malignancy and post marrow transplant recipients
- •Post cardiac surgery patients
- •Consent denial.
Outcomes
Primary Outcomes
To compare 28-day mortality outcomes between
Time Frame: To compare 28-day mortality outcomes between | early HFOV group and conventional/ rescue HFOV group.
early HFOV group and conventional/ rescue HFOV group.
Time Frame: To compare 28-day mortality outcomes between | early HFOV group and conventional/ rescue HFOV group.
Secondary Outcomes
- To determine the time taken for improvement in oxygenation and ventilatory parameters,(duration of ventilation and length of ICU stay.)
Investigators
Sathwik Gangireddy
All India Institute of Medical Sciences, Raipur