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Low versus high oxygen therapy in children admitted with coma

CONSERVATIVE VS STANDARD OXYGEN THERAPY IN CHILDREN WITH NON-TRAUMATIC COMA – AN OPEN LABELLED RANDOMIZED CONTROLLED TRIAL

Status
Recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/10/046432
Enrollment
142
Registered
2022-10-13
Start date
Unknown
Completion date
Unknown
Last updated
2023-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: G09- Sequelae of inflammatory diseasesof central nervous system

Interventions

Intervention1: Conservative Oxygen Therapy Group: Target Spo2 88-92%/Pao2-55-70mmHg: Participants allocated to the Conservative oxygen therapy group will receive supplemental oxygen and ventilator se

Sponsors

PGIMER
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All premorbid well children between the age group of >28 days to 12 completed years admitted to PICU with a diagnosis of non-traumatic coma requiring invasive ventilation will be enrolled within 48 hrs of initiation of mechanical ventilation

Exclusion criteria

Exclusion criteria: All children with severe acute respiratory distress syndrome (Appendix 10), Traumatic brain injury, congenital heart disease, previously known/chronic neurological illness, pulmonary hypertension, Sickle cell disease and parents who refused for consent will be excluded.

Design outcomes

Primary

MeasureTime frame
Glasgow outcome scale extended (GOS-E)Timepoint: Discharge,3 months

Secondary

MeasureTime frame
Adequacy of recruitment rates and protocol compliance with respect to duration of oxygen targetsTimepoint: At time of extubation from ventilation;Length of PICU stay, Ventilator free daysTimepoint: At the time of PICU discharge or transfer from PICU;QUALITY OF LIFE,POPC,PCPCTimepoint: At discharge, 3months;Survival statusTimepoint: 28days, 90 days;VIS, SOFATimepoint: Day 0,1,2,3,4 till child is discharged from PICU

Countries

India

Contacts

Public ContactDr Arun Bansal

PGIMER

drarunbansal@gmail.com9815455002

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026