| 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
|
|
|
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. |