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Clinical Trials/CTRI/2025/09/094156
CTRI/2025/09/094156
Not yet recruiting
Phase 3

Early vs Conventional High-Frequency Oscillatory Ventilation in Moderate and Severe Acute Respiratory Distress syndrome: An Open Labelled Randomized Superiority Controlled Trial

Division of Pediatric Critical Care Department of Pediatrics AIIMS Raipur1 site in 1 country50 target enrollmentStarted: September 16, 2025Last updated:

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

Sponsor
Division of Pediatric Critical Care Department of Pediatrics AIIMS Raipur
Sponsor Class
Government medical college
Responsible Party
Principal Investigator
Principal Investigator

Sathwik Gangireddy

All India Institute of Medical Sciences, Raipur

Study Sites (1)

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