A study to assess the clinical effectiveness of two surgeries (Decompressive Craniectomy and Cisternostomy) in patients with head injury requiring surgery
Not Applicable
- Conditions
- Health Condition 1: O- Medical and SurgicalHealth Condition 2: O- Medical and Surgical
- Registration Number
- CTRI/2023/08/056213
- Lead Sponsor
- All India Institute of Medical Sciences (AIIMS), New Delhi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1) Intra-operative ICP value post procedure <br/ ><br>2) Post-operative ICP value at 24,48 and 72 hours post -operatively.Timepoint: 1) Measured at the end of surgical procedure <br/ ><br>2) Measured at 24, 48 and 72 hours post operation
- Secondary Outcome Measures
Name Time Method 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