NCT06466811 Prediction of Undesired Obstruction in External Ventricular Drains.
| NCT ID | NCT06466811 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Nantes University Hospital |
| Condition | Intensive Care Unit |
| Study Type | OBSERVATIONAL |
| Enrollment | 640 participants |
| Start Date | 2024-07-04 |
| Primary Completion | 2026-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 640 participants in total. It began in 2024-07-04 with a primary completion date of 2026-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06466811 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Intensive Care Unit. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06466811 currently recruiting?
Yes, NCT06466811 is actively recruiting participants. Contact the research team at karim.lakhal@chu-nantes.fr for enrollment information.
Where is the NCT06466811 trial being conducted?
This trial is being conducted at Nantes, France.
Who is sponsoring the NCT06466811 clinical trial?
NCT06466811 is sponsored by Nantes University Hospital. The trial plans to enroll 640 participants.