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CTRI Number  CTRI/2025/09/094156 [Registered on: 03/09/2025] Trial Registered Prospectively
Last Modified On: 02/09/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of early high frequency ventilation on death in children with acute lung disease 
Scientific Title of Study   Early vs Conventional High-Frequency Oscillatory Ventilation in Moderate and Severe Acute Respiratory Distress syndrome: An Open Labelled Randomized Superiority Controlled Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sathwik Gangireddy 
Designation  Senior resident, Pediatric Critical Care 
Affiliation  All India Institute of Medical Sciences, Raipur 
Address  Room 2C3, C block 3rd floor, PICU, Department of Pediatrics, All India Institute of Medical Sciences, Raipur, India, 492001

Raipur
CHHATTISGARH
492001
India 
Phone  9786722877  
Fax    
Email  sathwik.reddy14@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Manas R Sahoo 
Designation  Associate Professor, Department of Pediatrics, AIIMS Raipur 
Affiliation  All India Institute of Medical Sciences, Raipur 
Address  Room 2C3, C block 3rd floor, PICU, Department of Pediatrics, All India Institute of Medical Sciences, Raipur, India, 492001

Raipur
CHHATTISGARH
492001
India 
Phone  9786722877  
Fax    
Email  drmrsahoo@gmail.com  
 
Details of Contact Person
Public Query  
Name  Sathwik Gangireddy 
Designation  Senior resident, Pediatric Critical Care 
Affiliation  All India Institute of Medical Sciences, Raipur 
Address  Room 2C3, C block 3rd floor, PICU, Department of Pediatrics, All India Institute of Medical Sciences, Raipur, India, 492001

Raipur
CHHATTISGARH
492001
India 
Phone  9786722877  
Fax    
Email  sathwik.reddy14@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, Raipur, India, 492001 
 
Primary Sponsor  
Name  Division of Pediatric Critical Care Department of Pediatrics AIIMS Raipur 
Address  Room 2C3, C block 3rd floor, PICU, Department of Pediatrics, All India Institute of Medical Sciences, Raipur, India, 492001 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Sathwik Gangireddy  All India Institute of Medical Sciences, Raipur  AIIMS Raipur Great Eastern Road, Tatibandh Raipur 492001 Chhattisgarh India
Raipur
CHHATTISGARH 		 9786722877

sathwik.reddy14@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC AIIMS RAIPUR  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J960||Acute respiratory failure,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Early high frequency oscillatory ventilation, a modality of invasive ventilation  Children diagnosed with moderate or severe acute respiratory distress syndrome are upfront initiated on high frequency oscillatory ventilation 
Comparator Agent  Rescue High Frequency Oscillatory Ventilation, a modality of invasive ventilation  Child diagnosed as moderate or severe acute respiratory distress syndrome is initially on conventional ventilation and if it fails then switched over to high frequency oscillatory ventilation 
 
Inclusion Criteria  
Age From  1.00 Month(s)
Age To  14.00 Year(s)
Gender  Both 
Details  Children aged 1 month to 14 years admitted in PICU, with
moderate and severe ARDS classified as per PALICC 1 guidelines. 
 
ExclusionCriteria 
Details  1. History of interstitial lung disease
2. Chronic renal failure
3. Central nervous system involvement: Especially raised intracranial pressure
4. Immunodeficient patients including malignancy and post marrow transplant recipients
5. Post cardiac surgery patients
6. Consent denial  
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To compare 28-day mortality outcomes between
early HFOV group and conventional/ rescue HFOV group. 		 To compare 28-day mortality outcomes between
early HFOV group and conventional/ rescue HFOV group. 
 
Secondary Outcome  
Outcome  TimePoints 
To determine the time taken for improvement in oxygenation and ventilatory parameters,
duration of ventilation and length of ICU stay.  		 Till patient is in ICU 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   16/09/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
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. 
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