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Intracranial Pressure After Decompressive Craniectomy

Intracranial Pressure After Decompressive Craniectomy

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03364634
Enrollment
17
Registered
2017-12-06
Start date
2015-10-01
Completion date
2017-07-30
Last updated
2017-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intracranial Hemorrhages, Intracranial Hypertension, Middle Cerebral Artery Stroke, Traumatic Brain Injury

Keywords

decompressive craniectomy, intracranial pressure, icp, telemetry, telemetric

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.

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.

Interventions

Weekly ICP monitoring sessions beginning at discharge from the neuro-intensive care unit and carried out until 1 month after cranioplasty.

Sponsors

Rigshospitalet, Denmark
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Intracranial pressure variationsWeekly monitoring sessions from discharge from the neuro-intensive care unit to 1 month after cranioplastyICP is measured in standardized body positions to investigate postural changes after decompressive craniectomy and following cranioplasty

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026