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| ID | Type | Description | Link |
|---|---|---|---|
| H-15009654 | Other Identifier | The Regional Committee on Health Research Ethics |
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Observational study to investigate the natural course of intracranial pressure (ICP) after decompressive craniectomy (DC) using long-term telemetric ICP monitoring. Patients will have continuous ICP measurement performed during the admission to the neuro-intensive care unit (NICU) and after discharge weekly measurements sessions will be performed before and after cranioplasty.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intracranial pressure monitoring | Diagnostic Test | Weekly ICP monitoring sessions beginning at discharge from the neuro-intensive care unit and carried out until 1 month after cranioplasty. |
| Measure | Description | Time Frame |
|---|---|---|
| Intracranial pressure variations | ICP is measured in standardized body positions to investigate postural changes after decompressive craniectomy and following cranioplasty | Weekly monitoring sessions from discharge from the neuro-intensive care unit to 1 month after cranioplasty |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients scheduled for a decompressive hemicraniectomy for elevated ICP (e.g. following severe traumatic brain injury) or signs of intracranial herniation (e.g. following cerebral edema in patients with middle cerebral artery infarction).
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| Label | URL |
|---|---|
| Website of Copenhagen CSF Study Group | View source |
| Website of Rigshospitalet (Copenhagen University Hospital), where the study is carried out | View source |
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| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D020244 | Infarction, Middle Cerebral Artery |
| D020300 | Intracranial Hemorrhages |
| D019586 | Intracranial Hypertension |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| D006259 |
| Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D002544 | Cerebral Infarction |
| D020520 | Brain Infarction |
| D002545 | Brain Ischemia |
| D002561 | Cerebrovascular Disorders |
| D002539 | Cerebral Arterial Diseases |
| D020765 | Intracranial Arterial Diseases |
| D020521 | Stroke |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D006470 | Hemorrhage |