Exploratory study to assess the practicality of a method for potentially evaluating the safety and clinical advantages of the MONTE monitor, for the management of intracranial hypertension in patients with traumatic brain injury in the future
Not Applicable
- Conditions
- Severe traumatic brain injury requiring sedation to control intracranial pressureInjury, Occupational Diseases, Poisoning
- Registration Number
- ISRCTN45963643
- Lead Sponsor
- niversitair Ziekenhuis Leuven
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 36
Inclusion Criteria
1. Adult patients (age =18 years old)
2. Severe traumatic brain injury
3. Continuous invasive intraparenchymal ICP monitoring
4. Patient requires sedation
Exclusion Criteria
1. Do-not-resuscitate (DNR) order
2. Bilateral dilated pupils or absence of pupil reflection
3. Pregnancy
4. Known pre-existing neurocognitive disorders or brain dysfunctions
5. Known pre-existing spinal cord injuries with loss of motor function
6. Primary decompressive craniectomy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method