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Influence of Drainage on EVD ICP-signal

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ClinicalTrials.gov Identifier: NCT03164434
Recruitment Status : Completed
First Posted : May 23, 2017
Last Update Posted : May 23, 2017
Sponsor:
Information provided by (Responsible Party):
prof. dr. Bart Depreitere, Universitaire Ziekenhuizen Leuven

Brief Summary:
This observational study investigates ICP signals obtained through an external ventricular drain in the brain connected with an external transducer. In particular, the study investigates how drainage influences the monitored signal: influence of flow rate, reservoir height and initial ICP before draining.

Condition or disease
Head Injury Subarachnoid Hemorrhage

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Influence of Drainage of Cerebrospinal Fluid on ICP Signals Obtained Through an External Ventricular Drain.
Study Start Date : September 2014
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. ICP signal changes [ Time Frame: immediate during drainage ]
    changes in magnitude and amplitude of ICP pulse during drainage of CSF



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with severe traumatic brain injury or subarachnoid hemorrhage in whom monitoring of ICP is warranted.
Criteria

Inclusion Criteria:

  • TBI/SAH patients with need for ICP monitoring

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03164434


Locations
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Belgium
University Hospitals Leuven
Leuven, Belgium, 3000
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
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Principal Investigator: Bart Depreitere, MD, PhD Universitaire Ziekenhuizen Leuven

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Responsible Party: prof. dr. Bart Depreitere, professor, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT03164434     History of Changes
Other Study ID Numbers: EVD-ICP
First Posted: May 23, 2017    Key Record Dates
Last Update Posted: May 23, 2017
Last Verified: May 2017

Keywords provided by prof. dr. Bart Depreitere, Universitaire Ziekenhuizen Leuven:
intracranial pressure
cerebrospinal fluid drainage
waveform analysis

Additional relevant MeSH terms:
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Hemorrhage
Subarachnoid Hemorrhage
Craniocerebral Trauma
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Trauma, Nervous System
Wounds and Injuries