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NCT03364634 Clinical Trial

Intracranial Pressure After Decompressive Craniectomy

Traumatic Brain Injury Clinical Trial

Official title:
Intracranial Pressure After Decompressive Craniectomy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03364634
Other study ID # ICPinDCv1.1
Secondary ID H-15009654
Status Completed
Phase N/A
First received December 1, 2017
Last updated December 1, 2017
Start date October 1, 2015
Est. completion date July 30, 2017

Study information
Verified date December 2017
Source Rigshospitalet, Denmark
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 17
Est. completion date July 30, 2017
Est. primary completion date July 30, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- age > 18 years

- scheduled for a decompressive hemicraniectomy for elevated ICP or signs of intracranial herniation

Exclusion Criteria:

- skin damage in the frontal area where the telemetric ICP sensor is implanted

- lack of informed consent from next-of-kin or the patient's general practitioner

Study Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Rigshospitalet, Denmark

Outcome
Type Measure Description Time frame Safety issue
Primary 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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