ow versus high oxygen therapy in children admitted with coma
Phase 2
- Conditions
- Health Condition 1: G09- Sequelae of inflammatory diseasesof central nervous system
- Registration Number
- CTRI/2022/10/046432
- Lead Sponsor
- PGIMER
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Glasgow outcome scale extended (GOS-E)Timepoint: Discharge,3 months
- Secondary Outcome Measures
Name Time Method 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 PIC