Prediction of Undesired Obstruction in External Ventricular Drains.

Recruiting

• Conditions: Intensive Care Unit; External Ventricular Drain; Intraventricular Hemorrhage

• Registration Number: NCT06466811
• Lead Sponsor: Nantes University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-05-14
• Study First Submitted QC: 2024-06-13
• Study First Posted: 2024-06-20
• Status Verified: 2024-07
• Study Start: 2024-07-04
• Last Update Submitted: 2024-07-11
• Last Update Posted: 2024-07-12
• Primary Completion: 2026-12-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 640

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assessment of the predictive value of IVH severity for EVD obstruction	From EVD insertion to removal up to 100 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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Nantes University Hospital; 🇫🇷 Nantes, Loire-Atlantique, France