Intracranial Pressure After Decompressive Craniectomy

NCT03364634 | Completed

• 2 other identifiers: ICPinDCv1.1H-15009654
• Study Type: observational
• Target: 17
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

decompressive craniectomy; intracranial pressure; icp; telemetry; telemetric

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients scheduled for a decompressive hemicraniectomy for elevated ICP (e.g. following severe traumatic brain injury) or signs of intracranial herniation (e.g. following cerebral edema in patients with middle cerebral artery infarction).

You may qualify if:

• age \> 18 years
• scheduled for a decompressive hemicraniectomy for elevated ICP or signs of intracranial herniation

You may not qualify if:

• 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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Related Links

• Website of Copenhagen CSF Study Group
• Website of Rigshospitalet (Copenhagen University Hospital), where the study is carried out

MeSH Terms

Conditions

Brain Injuries, Traumatic; Infarction, Middle Cerebral Artery; Intracranial Hemorrhages; Intracranial Hypertension

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD fellow

Study Record Dates

• First Submitted: December 1, 2017
• First Posted: December 6, 2017
• Study Start: October 1, 2015
• Primary Completion: July 30, 2017
• Study Completion: July 30, 2017
• Last Updated: December 6, 2017

Record last verified: 2017-12