Health Condition 1: O- Medical and Surgical Health Condition 2: O- Medical and Surgical
Conditions
Interventions
Intervention1: Cisternostomy: Cisternostomy is a novel microneurosurgical technique for TBI patients. TBI patients allocated to this arm will undergo surgical opening of the basal cisterns and intra-o
Sponsors
All India Institute of Medical Sciences (AIIMS), New Delhi
Eligibility
Inclusion criteria
Inclusion criteria: 1) GCS score at presentation >3 with the motor score being at least 2 or above. 2) Acute SDH with mass effect or Mid Line Shift (MLS) 3) Traumatic SAH with mass effect or MLS 4) Traumatic brain parenchymal contusions with mass effect or MLS 5) Post traumatic diffuse cerebral edema with mass effect or MLS
Exclusion criteria
Exclusion criteria: 1) GCS at presentation of less than 4 or motor score of 1 2) Patients with EDH as the main cause of MLS and mass effect which can be treated with a small craniotomy (small sized EDH co-existing with the primary pathology not considered) 3) Non-traumatic SAH or intra-parenchymal bleed 4) Acute infarcts with mass effect or MLS 5) Patients with any condition that precludes surgical intervention
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Intra-operative ICP value post procedure 2) Post-operative ICP value at 24,48 and 72 hours post -operatively.Timepoint: 1) Measured at the end of surgical procedure 2) Measured at 24, 48 and 72 hours post operation | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of hospital stayTimepoint: Measured on the day patient gets discharged from the hospital in the post-operative period;Duration of ICU stayTimepoint: Measured on the day patient gets shifted out from the ICU in the post operative period;Duration of Ventilator dependenceTimepoint: Measured on the day patient gets weaned off from ventilator in the post operative period;Glasgow Outcome Score (GOS) of the patients post dischargeTimepoint: At 3 months & 6 months post discharge;Ventilator dependenceTimepoint: Post operative day 5 & day 10 | — |
Countries
India
Contacts
Public ContactDr Het Shah
All India Institute of Medical Sciences (AIIMS), New Delhi
Outcome results
None listed