Clinical trial NCT06466811: Prediction of Undesired Obstruction in External Ventricular Drains.
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.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Intensive Care Unit
Intraventricular Hemorrhage
External Ventricular Drain
Keywords: Intensive care unit
External ventricular drain
Neuromeningeal infection
Obstruction
Intraventricular hemorrhage
Functional outcome
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2024-06-20
Enrollment: 640
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients hospitalized in an intensive care unit and having an EVD.

Brief summary: 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.


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

Primary outcomes:
measure: Assessment of the predictive value of IVH severity for EVD obstruction
timeFrame: From EVD insertion to removal up to 100 days.
Secondary outcomes:
measure: To evaluate if HIV is an independent risk factor for the occurrence of at least one episode of unplanned EVD obstruction.
timeFrame: From EVD insertion to removal up to 100 days.
measure: 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.
timeFrame: From EVD insertion to removal up to 100 days.
measure: Performance of IVH severity as a predictor of the occurrence of at least one episode of EVD obstruction within the first seven days
timeFrame: From EVD insertion to day 7.
measure: Evaluation of the 3 Graeb scores (original, modified and EVD) as predictors of the need for a new EVD insertion because of obstruction.
timeFrame: From EVD insertion to hospital discharge up to 12 months.
measure: Evaluation of the 3 Graeb scores (original, modified and EVD) as predictors of the need for cerebrospinal fluid internal shunt.
timeFrame: From EVD insertion to hospital discharge up to 12 months.
measure: 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.
timeFrame: From EVD insertion to hospital discharge up to 12 months
measure: To evaluate the effect of unplanned EVD obstruction on the functional outcome assessed on the day of hospital discharge and at 3±1 months.
timeFrame: From EVD insertion to month 3 (± 1 month) after IVH.
measure: To evaluate whether the Graeb-EVD, original Graeb, and modified Graeb scores are useful in predicting an EVD-related neuromeningeal infection.
timeFrame: From EVD insertion to ICU discharge up to 6 months.
measure: To evaluate the effect of unplanned EVD obstruction on the need for internalization of the ventricular shunt (ventriculoperitoneal or ventriculoatrial shunt).
timeFrame: From EVD insertion to ICU discharge up to 6 months.
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes University Hospital
state: Loire-Atlantique
Study officials:
References: