Prediction of Undesired Obstruction in External Ventricular Drains.

NCT06466811 | Recruiting

• 1 other identifier: RC24_0074
• Study Type: observational
• Target: 640
• Locations: 1 country
• Sites: 1

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.

Conditions

Intensive Care Unit; Intraventricular Hemorrhage; External Ventricular Drain

Keywords

Intensive care unit; External ventricular drain; Neuromeningeal infection; Obstruction; Intraventricular hemorrhage; Functional outcome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• 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.

• 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.

• 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.

• 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.

• 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.

Interventions

Patients of intensive care unit OTHER

Patients of intensive care unit having an EVD

Patients of surgical intensive care unit OTHER

Patients of surgical intensive care unit having an EVD.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

Nantes University Hospital

Nantes, Loire-Atlantique, 44093, France

RECRUITING

MeSH Terms

Conditions

Bites and Stings

Condition Hierarchy (Ancestors)

Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Central Study Contacts

Karim LAKHAL, PH

CONTACT

33 2 53 48 27 85; karim.lakhal@chu-nantes.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2024
• First Posted: June 20, 2024
• Study Start: July 4, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 12, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)