FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/03/063498 [Registered on: 04/03/2024] Trial Registered Prospectively
Last Modified On: 26/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Low PEEP/High FiO2 table compared to conventional method of PEEP titration]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   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. 
Scientific Title of Study   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. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Farhan Shaikh 
Designation  Head Dept of Pediatric Intensive Care Unit 
Affiliation  Rainbow Childrens Hospital 
Address  Floor 2 Rainbow Childrens Hospital Road 2 Banjara Hills Hyderabad

Hyderabad
TELANGANA
500034
India 
Phone  9866007602  
Fax    
Email  drfarhan@rainbowhospitals.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Farhan Shaikh 
Designation  Head Dept of Pediatric Intensive Care Unit 
Affiliation  Rainbow Childrens Hospital 
Address  Floor 2 Rainbow Childrens Hospital Road 2 Banjara Hills Hyderabad

Hyderabad
TELANGANA
500034
India 
Phone  9866007602  
Fax    
Email  drfarhan@rainbowhospitals.in  
 
Details of Contact Person
Public Query  
Name  Dr Latha 
Designation  Research Officier 
Affiliation  Rainbow Childrens Hospital 
Address  Research Room, Floor 2 Rainbow Childrens Hospital Road 2 Banjara Hills Hyderabad

Hyderabad
TELANGANA
500034
India 
Phone  9177100361  
Fax    
Email  lathasu@gmail.com  
 
Source of Monetary or Material Support  
Rainbow Childrens Hospital Banjara Hills Hyderabad 
 
Primary Sponsor  
Name  Rainbow Childrens Medicare Ltd 
Address  Road 2 Banjara Hills Hyderabad, India 
Type of Sponsor  Research institution and hospital 
 
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 
Dr Farhan Shaikh  Rainbow Childrens Hospital  Pediatric Intensive Care Unit, Floor 2, Rainbow Childrens Hospital Road 2, Banjara Hill Hyderabad
Hyderabad
TELANGANA 		 9866007602

drfarhan@rainbowhospitals.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Rainbow Childrens Hospital EC for Biomedical And Health Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J80||Acute respiratory distress syndrome,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional PEEP titration  Optimal PEEP will be selected based on recruitment with gradually increasing PEEP till plateau pressures are 28 or driving pressures are below 15. And then, gradually decreasing PEEP till PEEP of 5 and optimal PEEP will be selected based on best lung compliance and least driving pressure. 
Intervention  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. 
 
Inclusion Criteria  
Age From  1.00 Month(s)
Age To  18.00 Year(s)
Gender  Both 
Details  Invasively ventilated children more than 1 month and up to 18 years age with pARDS diagnosed as per PALICC-2 
 
ExclusionCriteria 
Details  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)
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 

To assess the changes in oxygenation index at the end of 48 hrs 
To assess the changes in oxygenation index at the end of 48 hrs 
 
Secondary Outcome  
Outcome  TimePoints 
28-Day ventilation Free days and Mortality difference between the groups.  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. 		 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. 		 28 days 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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   N/A 
Date of First Enrollment (India)   11/03/2024 
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="10" 
Recruitment Status of Trial (Global)
Modification(s)  		 Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
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
Modification(s)  		 This is a Randomised control trial to compare the predesigned table (low PEEP/High FiO2 table)with conventional method of peep titration available, in children.This is our pilot effort to establish the clinical utility of this table in deciding the Pressure adjustment during mechanical ventilation. We will be comparing this technique with conventional method followed in our hospital.

Current status of the study (interim analysis ) total 37 children were recruited till now.19 children were randomised to LOW-PEEP HIGH-FIO2 table group , while 18 were in the conventional PEEP titration there was a significant change in Oxygenation Index (OI) across different time points (At Zero , 12  , 24 , 36, and 48hrs), regardless of arm membership (P-value for Time = 0.026). The two arms did not  significantly differ in OIacross all time points (P-value for Arm = 0.204). Similarly,there was a significant change in PaO2/FiO2 (PF) ratio across same different time points, regardless of arm membership (P-value for Time <0.001). The two arms did not have significantdifference in PF ratio across all time points (P-value for Arm = 0.229).There was no significant difference between driving pressure , mechanical power, plateau pressure and dead space fraction between the two arms at  48hours.There was no difference in incidence of air leaks, hemodynamic instability and pulmonary bleeds between the two groups.
 
Close