Intracranial Pressure After Decompressive Craniectomy

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.

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Key information

Conditions

Traumatic Brain Injury Brain Diseases Brain Infarction Brain Injuries Brain Injuries, Traumatic Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebral Arterial Diseases Cerebral Infarction Cerebrovascular Disorders Craniocerebral Trauma Hemorrhage Infarction Infarction, Middle Cerebral Artery Intracranial Arterial Diseases Intracranial Hemorrhages Intracranial Hypertension Ischemia Middle Cerebral Artery Stroke Necrosis Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Trauma, Nervous System Vascular Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

Intracranial pressure variations

Time frame: 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

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Important dates

Study start: 2015
Primary completion: 2017
Study completion: 2017
First posted: Dec 6, 2017
Registry last updated: Dec 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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