Health Condition 1: S098- Other specified injuries of head
Conditions
Interventions
Intervention1: Cerebral oximetry: Cerebral oximetry, adhesive electrodes will be attached to each side of the forehead of the head-injured patient for a period of 72 hours to detect changes in the oxy
Sponsors
JIPMER
Eligibility
Inclusion criteria
Inclusion criteria: We will include non-operatively managed, adult, TBI patients who present within 24 hours of trauma, and in whom the treating team anticipates a progression of CT findings or clinical deterioration in the next three days. This could be based on any combination of findings such as sizable contusions, acute subdural hematoma, and brain edema with partial or complete obliteration of cisterns. The decision will be made by the treating team. Since there are innumerable clinical situations, and due to the absence of level 1 (RCT) evidence for surgical decision making, we are not providing strict, exhaustive criteria, but we would like to leave it to the treating teamâ??s best judgment.
Exclusion criteria
Exclusion criteria: Patients who require immediate operative intervention as per judgment of the treatment team which is expected to follow the guidelines of the Brain Trauma Foundation. (The guidelines of the BTF for surgical intervention are not level 1 but are expert opinions themselves) Patients who are planned for barbiturate coma or similar burst suppression techniques. Pure diffuse axonal injury without edema or significant hematoma or cisternal obliteration where deterioration is only expected because of progressive axonal damage. Pure brainstem contusions or pure posterior fossa hematomas. A patient with traumatic great vessel dissection causing an infarct that is visible in the initial scan. Patients who have multiple system injuries besides TBI, who could go into hypotension or hypoxia that could affect the rSO2 levels or who are already in hypotension or hypoxia due to any cause. Patients who have large skin abrasion or laceration or contusion over the forehead, that prevents the application of the sensor electrodes A patient with an extradural hematoma or a thick subdural hematoma (1 cm or more) or thick pneumocephalus (5 mm or more, confluent) overlying the frontal brain at the forehead area since the signal might be absorbed by the blood or air. A patient with grossly depressed fracture at the forehead area Patients who are in a poor neurological status that survival for a period of one week is deemed unlikely A patient with previous cranioplasty or surgical evacuation of a hematoma that caused a porencephalic change in the frontal lobes that could interfere with measurements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determine the diagnostic value of a drop in rSO2 (cerebral oximetry) in estimating the proportion of patients who have a radiological or clinical deterioration. Timepoint: Three days (72) hours from the time of application of the diagnostic device | — |
Secondary
| Measure | Time frame |
|---|---|
| Determine the duration of the drop in rSO2 in patients with actionable clinical or radiological deterioration Timepoint: Three days (72) hours from the time of application of the diagnostic device ;Determine the median lead time that cerebral oximetry provides before clinical and radiological deterioration occurs. Timepoint: Three days (72) hours from the time of application of the diagnostic device ;Determine the proportion of patients in whom cerebral oximetry could detect a drop in rSO2 before an actionable radiological and clinical deterioration occurred. An actionable deterioration is a radiological or clinical change that was severe enough to do operation, or do an invasive intracranial pressure monitoring or do a non-scheduled CT scan.Timepoint: Three days (72) hours from the time of application of the diagnostic device ;Determine the severity of the drop in rSO2 in patients with actionable clinical or radiological deterioration Timepoint: Three days (72) hours from the time of application of the diagnostic device | — |
Countries
India
Contacts
Public ContactHem Chander Pandey
JIPMER
Outcome results
None listed