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CTRI Number  CTRI/2023/11/060105 [Registered on: 21/11/2023] Trial Registered Prospectively
Last Modified On: 20/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Oxygen therapy saturation target]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of Low vs high oxygen saturation in PICU patients  
Scientific Title of Study   Conservative versus Conventional oxygenation target in children admitted in PICU - A Randomised Controlled Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shubham verma 
Designation  Senior resident DM Pediatric critical care  
Affiliation  AIIMS Raipur 
Address  4 Floor, D block, Pediatric office, AIIMS raipur

Raipur
CHHATTISGARH
492099
India 
Phone  8090219490  
Fax    
Email  shubhamverma2812@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Atul Jindal 
Designation  additional professor, Department of Pediatrics 
Affiliation  AIIMS Raipur 
Address  room no 1111, medical college building, AIIMS raipur

Raipur
CHHATTISGARH
492099
India 
Phone  8224014667  
Fax    
Email  dratuljindal@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Shubham verma 
Designation  Senior resident DM Pediatric critical care  
Affiliation  AIIMS Raipur 
Address  4 floor, D block, Pediatric office, AIIMS Raipur

Raipur
CHHATTISGARH
492099
India 
Phone  8090219490  
Fax    
Email  shubhamverma2812@gmail.com  
 
Source of Monetary or Material Support  
AIIMS raipur, tatibandh, Raipur, chattisgarh 
 
Primary Sponsor  
Name  Shubham Verma  
Address  First floor, Divya Kunj, Shantinath nagarTatibandh, Raipur 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
AIIMS Raipur   AIIMS Raipur, tatibandh, raipur 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Shubham verma  AIIMS Raipur  Department of Pediatrics, AIIMS Raipur, tatibandh
Raipur
CHHATTISGARH 
8090219490

shubhamverma2812@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: 4||Measurement and Monitoring,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Oxygen  Oxygen titration to maintain peripheral saturation target 88-92%. Oxygen FIO2 21 to 100% 
Comparator Agent  oxygen   Oxygen titration to maintain peripheral saturation target 94-99%. Oxygen FIO2 21 to 100% 
 
Inclusion Criteria  
Age From  2.00 Month(s)
Age To  14.00 Year(s)
Gender  Both 
Details  Age >1 month to <15 year, who need oxygen therapy for hypoxia or distress in form of invasive or non invasive support 
 
ExclusionCriteria 
Details 
Death is imminent
Brain pathology/ injury as primary reason for admission
(traumatic brain injury, post cardiac arrest, stroke, convulsive status epilepticus without aspiration)
Known pulmonary hypertension
Known sickle cell disease/ Anaemia Hb < 7 g/dl
Known uncorrected congenital heart disease
End of life care plan with limit to resuscitation
Long term invasive ventilation prior to admission
Recruited in previous admission 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Clinical outcome for composite of death & days of organ support at 4 weeks  Clinical outcome for composite of death & days of organ support at 4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Mortality at PICU discharge
Days of ventilation needed
Duration of organ support
Functional status at PICU discharge
Length of PICU & hospital stay 
30 days 
 
Target Sample Size   Total Sample Size="400"
Sample Size from India="400" 
Final Enrollment numbers achieved (Total)= "178"
Final Enrollment numbers achieved (India)="178" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   01/07/2024 
Date of Study Completion (India) 30/11/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 30/11/2024 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
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)  
Soon after admission to Pediatric intensive care unit, Department of Pediatrics, AIIMS, Raipur, the patient will undergo screening for enrolment based on inclusion and exclusion criteria. If the patient does not meet the inclusion criteria, he/she will be excluded. As hypoxia can be life threatening and delay can be detrimental oxygen therapy will be started as soon as possible as per unit protocol and clinician judgement. After stabilisation, and inclusion into the study informed consent will be obtained from the patient’s legal guardian. Once consent is obtained patient will be randomised using computer generated block randomisation with concealed allocation. The primary details and the disease status of the patient will be recorded in both the groups. Participants will be randomly allocated (1:1) to either the conservative (88%–92%) or conventional (94%-99%) oxygen target group by a computer-generated dynamic procedure (minimisation) with a random component. Patient in the intervention group will be monitored and titrated to maintain oxygen saturation 88- 92 % with titration of FIO2 and pressure support. This will be continued until all respiratory support (delivered invasively or non-invasively) has been discontinued during this PICU admission.
Prior to randomisation, all care will be determined by the clinical team primarily responsible for the child’s treatment and care. Once randomised, all care other than that intended to achieve trial target SpO2 will be determined by the clinical team. Patient will be monitored hourly SpO2 for duration of need of oxygen support. PaO2 will be monitored at baseline and as per patient clinical need and on clinician judgement. At the baseline and at the end of 7 days or end of oxygen therapy whichever is earlier, we will send serum quantitative MDA levels to see oxidative stress in patients. Clinical parameters, need of ventilation support, duration of ventilation, organ dysfunction, mortality will be recorded till day 30 of inclusion and/ or till PEM/ PICU/ HDU stay. Primary and secondary outcome will be recorded in prescribed format for 30 day after enrolment.
 
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