Prediction of Undesired Obstruction in External Ventricular Drains.

Intensive Care Unit Clinical Trial

— EVD-OBS  

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06466811
• Other study ID #: RC24_0074
• Status: Not yet recruiting
• Start date: July 1, 2024
• Est. completion date: December 1, 2026

Study information

• Verified date: May 2024
• Source: Nantes University Hospital
• Contact: Karim LAKHAL, PH
• Phone: 33 2 53 48 27 85
• Email: karim.lakhal[@]chu-nantes.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 640
• Est. completion date: December 1, 2026
• Est. primary completion date: December 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• External Ventricular Drain
• Hemorrhage
• Intensive Care Unit
• Intraventricular Hemorrhage

Intervention

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

Locations

Country	Name	City	State
France	Nantes University Hospital	Nantes	Loire-Atlantique

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of the predictive value of IVH severity for EVD obstruction	HIV severity will be estimated using an adaptation of the existing Graeb's score: the Graeb-EVD score. EVD obstruction is defined by an abnormally reduced drainage flow, requiring intervention to restore normal function (cases of EVD malposition will be excluded).The predictive performance of the Graeb-EVD score will be evaluated by the area under the receiver operating characteristic curve (AUC-ROC). The AUC-ROC ranges from 0 to 1. The predictive ability will be considered acceptable if associated with an AUC-ROC greater than 0.70, good if greater than 0.80, and excellent if greater than 0.90.	From EVD insertion to removal up to 100 days.
Secondary	To evaluate if HIV is an independent risk factor for the occurrence of at least one episode of unplanned EVD obstruction.	The researcher will study the risk factors for the occurrence of at least one episode of unplanned EVD obstruction (dependent variable in a logistic regression model) by forcing the inclusion of HIV into this model as an explanatory variable. If the 95% confidence interval of the adjusted odds ratio associated with HIV is greater than 1, HIV will be considered an independent risk factor for unplanned EVD obstruction.	From EVD insertion to removal up to 100 days.
Secondary	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.	A p-value of <0.05 in the pairwise comparison of areas under the receiver operating characteristics curves will be used to assert the superiority of the performance of one score over another.	From EVD insertion to removal up to 100 days.
Secondary	Performance of IVH severity as a predictor of the occurrence of at least one episode of EVD obstruction within the first seven days	HIV severity will be estimated using an adaptation of the existing Graeb's score: the Graeb-EVD score. EVD obstruction is defined by an abnormally reduced drainage flow, requiring intervention to restore normal function (cases of EVD malposition will be excluded). The predictive performance of the Graeb-EVD score will be evaluated by the area under the receiver operating characteristic curve (AUC-ROC). The AUC-ROC ranges from 0 to 1. The predictive ability will be considered acceptable if associated with an AUC-ROC greater than 0.70, good if greater than 0.80, and excellent if greater than 0.90.	From EVD insertion to day 7.
Secondary	Evaluation of the 3 Graeb scores (original, modified and EVD) as predictors of the need for a new EVD insertion because of obstruction.	The predictive performance of the tested scores will be evaluated by the AUC-ROC. The predictive capacity will be considered acceptable if associated with an AUC-ROC greater than 0.70, good if greater than 0.80, and excellent if greater than 0.90.	From EVD insertion to hospital discharge up to 12 months.
Secondary	Evaluation of the 3 Graeb scores (original, modified and EVD) as predictors of the need for cerebrospinal fluid internal shunt.	The predictive performance of the tested scores will be evaluated by the AUC-ROC. The predictive capacity will be considered acceptable if associated with an AUC-ROC greater than 0.70, good if greater than 0.80, and excellent if greater than 0.90.	From EVD insertion to hospital discharge up to 12 months.
Secondary	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.	Functional outcome will be considered unfavorable if the modified Rankin scale (ranging from 0 to 6) is 2 or higher, and favorable otherwise. The predictive performance of the tested scores will be evaluated by the AUC-ROC. A score will be considered useful if it is associated with an AUC-ROC significantly greater than 0.50.	From EVD insertion to hospital discharge up to 12 months
Secondary	To evaluate the effect of unplanned EVD obstruction on the functional outcome assessed on the day of hospital discharge and at 3±1 months.	Functional outcome will be considered unfavorable if the modified Rankin scale is 2 or higher, and favorable otherwise. A multivariate analysis involving risk factors for poor functional outcome (dependent variable) and incorporating the occurrence of at least one episode of unplanned EVD obstruction (explanatory variable) will be conducted. If the 95% confidence interval does not include the value 1, then the variable will be retained as an independent risk factor for the occurrence of the dependent variable. As an explanatory variable, we will test, in separate models, the occurrence of at least one episode of unplanned obstruction and the occurrence of at least two episodes.	From EVD insertion to month 3 (± 1 month) after IVH.
Secondary	To evaluate whether the Graeb-EVD, original Graeb, and modified Graeb scores are useful in predicting an EVD-related neuromeningeal infection.	Neuromeningeal infection is defined as the administration of antimicrobial therapy for this specific indication for at least 10 days. The predictive performance will be assessed through the area under the receiver operating characteristics curve.	From EVD insertion to ICU discharge up to 6 months.
Secondary	To evaluate the effect of unplanned EVD obstruction on the need for internalization of the ventricular shunt (ventriculoperitoneal or ventriculoatrial shunt).	A multivariate analysis involving risk factors for the need for internalization of the ventricular shunt (dependent variable) and incorporating the occurrence of at least one episode of unplanned EVD obstruction (explanatory variable) will be conducted. If the 95% confidence interval does not include the value 1, then the variable will be retained as an independent risk factor for the occurrence of the dependent variable.	From EVD insertion to ICU discharge up to 6 months.