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Recruiting NCT06466811

Prediction of Undesired Obstruction in External Ventricular Drains.

— Observational Intensive Care Unit Intraventricular Hemorrhage External Ventricular Drain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Patients of intensive care unit, Patients of surgical intensive care unit.
Who it may be relevant to
Registry conditions: Intensive Care Unit, Intraventricular Hemorrhage, External Ventricular Drain. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Identification of Patients at Risk of Undesired Obstruction in External Ventricular Drain: Development of a Score Based on the Extent of Intra-ventricular Hemorrhage. A Single-Center, Prospective Observational Study.

Overview

Acute obstructive hydrocephalus often complicates intraventricular hemorrhage (IVH). The insertion of an external ventricular drain (EVD) is typically necessary in order to alleviate intracranial pressure by draining excess fluid. However, dysfunction of the EVD whether due to malposition or obstruction, can exacerbate hydrocephalus in an already compromised brain. EVD dysfunction must therefore be promptly detected and treated. Consequently, identifying high-risk patients and closely monitoring them is imperative. While IVH is known to increase the risk of obstruction in the natural cerebrospinal fluid outflow tract, its association with ventricular drain obstruction remains unproven.

Interventions

  • Other Patients of intensive care unit
    Patients of intensive care unit having an EVD
  • Other Patients of surgical intensive care unit
    Patients of surgical intensive care unit having an EVD.

Primary outcome measures

  • Assessment of the predictive value of IVH severity for EVD obstruction [Time frame: From EVD insertion to removal up to 100 days.]
Secondary outcome measures (9)
  • To evaluate if HIV is an independent risk factor for the occurrence of at least one episode of unplanned EVD obstruction. [Time frame: From EVD insertion to removal up to 100 days.]
  • Comparison of the performance of the Graeb-EVD score with that of the original Graeb score and the modified Graeb scores for the prediction of the occurrence of at least one episode of EVD obstruction. [Time frame: From EVD insertion to removal up to 100 days.]
  • Performance of IVH severity as a predictor of the occurrence of at least one episode of EVD obstruction within the first seven days [Time frame: From EVD insertion to day 7.]
  • Evaluation of the 3 Graeb scores (original, modified and EVD) as predictors of the need for a new EVD insertion because of obstruction. [Time frame: From EVD insertion to hospital discharge up to 12 months.]
  • Evaluation of the 3 Graeb scores (original, modified and EVD) as predictors of the need for cerebrospinal fluid internal shunt. [Time frame: From EVD insertion to hospital discharge up to 12 months.]
  • To evaluate whether the Graeb-EVD, original Graeb, and modified Graeb scores are useful in predicting an unfavorable functional outcome on the day of hospital discharge and at 3±1 months. [Time frame: From EVD insertion to hospital discharge up to 12 months]
  • To evaluate the effect of unplanned EVD obstruction on the functional outcome assessed on the day of hospital discharge and at 3±1 months. [Time frame: From EVD insertion to month 3 (± 1 month) after IVH.]
  • To evaluate whether the Graeb-EVD, original Graeb, and modified Graeb scores are useful in predicting an EVD-related neuromeningeal infection. [Time frame: From EVD insertion to ICU discharge up to 6 months.]
  • To evaluate the effect of unplanned EVD obstruction on the need for internalization of the ventricular shunt (ventriculoperitoneal or ventriculoatrial shunt). [Time frame: From EVD insertion to ICU discharge up to 6 months.]

Eligibility criteria

Inclusion criteria

Patient older than 18 years old,

  • admitted to the ICU,
  • with first EVD inserted for less than 12 hours,
  • and brain imaging (CT or MRI) available in the timespan "24 hours before to 24 hours after" the EVD insertion.

Exclusion criteria

  • EVD intentionally occluded immediately after its insertion,
  • purulent cerebrospinal fluid
  • Pregnant or breast-feeding patient
  • Moribund patient or patient with decision of withholding or withdrawing life-sustaining treatment within the 12 hours
  • Patient with no health insurance
  • Patient under guardianship

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 1 center
  • Nantes University Hospital — Nantes

Identifiers

NCT: NCT06466811 · RC24_0074

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗