Status:
UNKNOWN
Validation of Non-invasive Absolute Intracranial Pressure Monitoring
Lead Sponsor:
Kienzler Jenny
Collaborating Sponsors:
Swiss National Science Foundation
Conditions:
Intracranial Pressure Increase
Traumatic Brain Injury
Eligibility:
All Genders
18+ years
Brief Summary
Primary objective of this study is to assess the accuracy and precision of intracranial pressure (ICP) measurement in patients after traumatic brain injury and subarachnoid hemorrhage when using simul...
Detailed Description
Currently, ICP (Intracranial Pressure) can be measured only using invasive techniques. In a previous (pilot study) a non-invasive technique for measurement of ICP was investigated (based on simultaneo...
Eligibility Criteria
Inclusion
- Adult patients, age ≥ 18 years, admitted after TBI, ICH, secondary edema after stroke or SAH at the Departments of Neurosurgery or Neurology, Kantonsspital Aarau, Switzerland.
- Patients under sedation and ICP monitoring
- Informed consent obtained from the legally authorized representative prior initiation of the measurements.
Exclusion
- Age \< 18 years at study entry.
- Patients with wounds, scars including the front orbital region.
- Perforating or penetrating mechanism of TBI
- Patients with orbital injury or abnormal blood flow in both Ophthalmic Arteries
- Patients with previous retina surgery
- Patients with previous cataract surgery
- Patients with any known ocular condition that may be worsened by sustained eye pressure in the opinion of the subject's ophthalmologist
- Patients with radiological signs of calcification or atheromatose plaques in the internal carotid artery detected by CT or angiography (performed prior and independently of the study)
Key Trial Info
Start Date :
September 1 2017
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2019
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT03227354
Start Date
September 1 2017
End Date
September 1 2019
Last Update
July 28 2017
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