Trials / Completed
CompletedNCT03364634
Intracranial Pressure After Decompressive Craniectomy
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 17 (actual)
- Sponsor
- Rigshospitalet, Denmark · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
- Traumatic Brain Injury
- Middle Cerebral Artery Stroke
- Intracranial Hemorrhages
- Intracranial Hypertension
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2015-10-01
- Primary completion
- 2017-07-30
- Completion
- 2017-07-30
- First posted
- 2017-12-06
- Last updated
- 2017-12-06
Source: ClinicalTrials.gov record NCT03364634. Inclusion in this directory is not an endorsement.