Prediction of Undesired Obstruction in External Ventricular Drains.

NCT ID: NCT06466811

Last Updated: 2024-07-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

640 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-07-04

Study Completion Date

2026-12-01

Brief Summary

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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

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Conditions

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Intensive Care Unit Intraventricular Hemorrhage External Ventricular Drain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Patients of intensive care unit

Patients of intensive care unit having an EVD

Intervention Type OTHER

Patients of surgical intensive care unit

Patients of surgical intensive care unit having an EVD.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nantes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Nantes University Hospital

Nantes, Loire-Atlantique, France

Site Status RECRUITING

Countries

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France

Central Contacts

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Karim LAKHAL, PH

Role: CONTACT

33 2 53 48 27 85

Facility Contacts

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Karim LAKHAL, PH

Role: primary

Other Identifiers

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RC24_0074

Identifier Type: -

Identifier Source: org_study_id

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