Health Condition 1: null- Children aged 6-month to 12 years with features of raised ICP and m-GCS equal and less than eight due to non-traumatic coma)
Conditions
Interventions
Intervention1: ICP-targeted therapy group: General measures for raised ICP and placement of ICP catheter and targeting the ICP 20 mm Hg or less.
Intervention2: CPP-targeted therapy group: General meas
Sponsors
The Director
Eligibility
Inclusion criteria
Inclusion criteria: Children aged 6-month to 12 years and m-GCS less than or equal 8 and raised ICP due to non-traumatic coma.
Exclusion criteria
Exclusion criteria: Patients with one or more of the following condition(s) will be excluded: Unstable hemodynamic (BP <5th centile for given age, sex, length/height / ongoing resuscitation), TBI, subarachnoid hemorrhage, epidural or subdural hematoma, hydrocephalus, CNS tumors, hypertensive encephalopathy, coagulopathy, infection at the site of insertion, subdural and epidural infection, brain abscess, neurodevelopmental delay or chronic neurologic illness, tuberculous meningitis, cerebral malaria and clinical brain death (as specified by human organ transplant act
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the proportion of patients who had the poor composite outcome (mortality or severe neurodisability) at 90 days of randomization in three study groups (routine focused care vs. conventional intracranial targeted vs. new cerebral perfusion pressure targeted therapy groups).Timepoint: 90days | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse effects (like technical complications related to intracranial pressure catheter placement and therapy/intervention-related complications â?? hypo/hypertension, hypernatremia, hyperosmolar state).Timepoint: 72 hours and discharge and 90 days;Cost involved in the three groups and effectiveness (cost effective analysis) will be compared among the study groups.Timepoint: 90 days;Hearing deficit and functional neurodisability (assessed as a functional status on Pediatric Cerebral Performance Category scale) at the time of discharge from pediatric intensive care unit and at 90 days after discharge.Timepoint: 90 days;The length of stay in hospital (including pediatric intensive care unit stay) and mechanical ventilation.Timepoint: 90 days;The proportion of patients with modified-Glasgow Coma Scale (m-GCS) of 9 or more at 72 hours after enrollment, at the time of ICP catheter removal and PICU discharge.Timepoint: At 72 hours and discharge and 90 days;Types of intervention used (like a fluid bolus, osmotherapy, vasoactive therapy, hyperventilation duration, and barbiturate comaTimepoint: 72 hours and discharge and 90 days | — |
Countries
India
Contacts
Public ContactDr R Ramesh Kumar
JIPMER
Outcome results
None listed