Intracranial Pressure After Decompressive Craniectomy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03364634|
Recruitment Status : Completed
First Posted : December 6, 2017
Last Update Posted : December 6, 2017
|Condition or disease||Intervention/treatment|
|Traumatic Brain Injury Middle Cerebral Artery Stroke Intracranial Hemorrhages Intracranial Hypertension||Diagnostic Test: Intracranial pressure monitoring|
Several studies have investigated and documented the effect of DC in lowering ICP in intracranial hypertension following acute brain injuries, e.g. severe traumatic brain injury. But the natural course of ICP in these patients after the acute phase in the NICU has never been investigated. Clinical experience suggests that a DC affects cerebrospinal fluid circulation and ICP, e.g. causing hydrocephalus or subdural hygromas.
The aim of this observational study is to document the natural course of ICP following DC and to investigate the effect of cranioplasty on ICP. This is done by implantation of a telemetric ICP sensor and weekly follow-up monitoring sessions after discharge from the NICU until 1 month after cranioplasty. The monitoring sessions will include standardized body positions to investigate postural ICP changes before and after cranioplasty. The project will also provide experience with telemetric ICP monitoring during the acute phase in a NICU setting.
|Study Type :||Observational|
|Actual Enrollment :||17 participants|
|Official Title:||Intracranial Pressure After Decompressive Craniectomy|
|Actual Study Start Date :||October 1, 2015|
|Actual Primary Completion Date :||July 30, 2017|
|Actual Study Completion Date :||July 30, 2017|
- Diagnostic Test: Intracranial pressure monitoring
Weekly ICP monitoring sessions beginning at discharge from the neuro-intensive care unit and carried out until 1 month after cranioplasty.
- Intracranial pressure variations [ Time Frame: Weekly monitoring sessions from discharge from the neuro-intensive care unit to 1 month after cranioplasty ]ICP is measured in standardized body positions to investigate postural changes after decompressive craniectomy and following cranioplasty