Intracranial Pressure After Decompressive Craniectomy

Sponsor

Rigshospitalet, Denmark (Other)

Overall Status

Completed

CT.gov ID

NCT03364634

Collaborator

(none)

Enrollment

21.9

Actual Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Traumatic Brain Injury Middle Cerebral Artery Stroke Intracranial Hemorrhages Intracranial Hypertension	Diagnostic Test: Intracranial pressure monitoring

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.

Study Design

Study Type:

Observational

Actual Enrollment :

17 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Intracranial Pressure After Decompressive Craniectomy

Actual Study Start Date :

Oct 1, 2015

Actual Primary Completion Date :

Jul 30, 2017

Actual Study Completion Date :

Jul 30, 2017

Outcome Measures

Primary Outcome Measures

Intracranial pressure variations [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