Actively Recruiting

Age: 18Years +
All Genders
ID06466811

Identification of Patients at Risk of Undesired Obstruction in External Ventricular Drain Based on Intraventricular Hemorrhage Extent: A Single-Center Prospective Observational Study

Led by Nantes University Hospital · Updated on 2024-07-12

640

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This research investigates acute obstructive hydrocephalus, a condition often arising from intraventricular hemorrhage (IVH) that requires the use of an external ventricular drain (EVD) to relieve pressure in the brain. The study aims to develop a score based on the extent of IVH to identify patients at high risk of undesired EVD obstruction, which can worsen hydrocephalus and complicate treatment. The relationship between IVH severity and EVD obstruction remains unclear, making this study important for improving patient monitoring. Participants are patients admitted to the intensive care unit (ICU) who have had an EVD inserted within the past 12 hours and have recent brain imaging available. The study is observational and does not involve experimental treatments. Researchers will monitor patients from the time of EVD insertion until removal, for up to 100 days, to assess the predictive value of IVH severity on EVD obstruction. Additional evaluations include comparing different scoring systems and examining outcomes such as the need for new EVD insertion, shunt placement, infections, and functional status up to 12 months. Throughout the study, participants will undergo clinical assessments, brain imaging reviews (CT or MRI), and tracking of any episodes of EVD obstruction. The main outcome measured is whether IVH severity predicts EVD obstruction. Secondary outcomes include infection risks, shunt requirements, and functional outcomes at hospital discharge and up to three months. The study will follow patients closely during their ICU stay and hospital course, with data collection continuing for up to a year. This thorough monitoring helps researchers understand risks and improve care for patients with IVH and EVDs.

CONDITIONS

Brief Title

Prediction of Undesired Obstruction in External Ventricular Drains.

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient older than 18 years old
  • Admitted to the intensive care unit (ICU)
  • First external ventricular drain (EVD) inserted less than 12 hours ago
  • Brain imaging (CT or MRI) performed within 24 hours before or after EVD insertion
Not Eligible

You will not qualify if you...

  • EVD intentionally blocked immediately after insertion
  • Presence of purulent cerebrospinal fluid
  • Pregnant or breastfeeding
  • Moribund or decision to withhold/withdraw life-sustaining treatment within 12 hours
  • No health insurance
  • Under guardianship

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

Duration - Up to 100 days from EVD insertion to removal

Participants who have an external ventricular drain (EVD) inserted are observed to assess the risk and occurrence of unplanned EVD obstruction and related outcomes.

Visits occur as part of routine intensive care unit care up to 100 days

Long-term Monitoring

Duration - Up to 12 months from EVD insertion to hospital discharge and beyond

Participants are followed to evaluate functional outcomes, infection risks, and need for further interventions up to 12 months after EVD insertion.

Follow-up visits up to hospital discharge and up to 12 months, including assessments at ICU discharge and 3 months (±1 month)

Trial Site Locations

Total: 1 location

1

Nantes University Hospital

Nantes, Loire-Atlantique, France, 44093

Actively Recruiting

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Research Team

K

Karim LAKHAL, PH

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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