Prediction of Undesired Obstruction in External Ventricular Drains. (EVD-OBS)

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Intraventricular Hemorrhage; Intensive Care Unit; External Ventricular Drain
• Intervention / Treatment: Other: Patients of intensive care unit; Other: Patients of surgical intensive care unit

• Study Type: Observational
• Enrollment (Estimated): 640

Contacts and Locations

• Study Contact: Name: Karim LAKHAL, PH; Phone Number: 33 2 53 48 27 85; Email: karim.lakhal@chu-nantes.fr

Study Locations

• France
  • Loire-Atlantique
    • Nantes, Loire-Atlantique, France, 44093
      • Recruiting
      • Nantes University Hospital
      • Contact: Karim LAKHAL, PH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients hospitalized in an intensive care unit and having an EVD.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.
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.
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.
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
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.
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.
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.

Collaborators and Investigators

• Sponsor: Nantes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 4, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: May 14, 2024
• First Submitted That Met QC Criteria: June 13, 2024
• First Posted (Actual): June 20, 2024

Study Record Updates

• Last Update Posted (Actual): July 12, 2024
• Last Update Submitted That Met QC Criteria: July 11, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Intensive care unit; Obstruction; Functional outcome; Intraventricular hemorrhage; External ventricular drain; Neuromeningeal infection
• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage
• Other Study ID Numbers: RC24_0074

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No