Prediction of Undesired Obstruction in External Ventricular Drains.
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorNantes University Hospital
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial population
Adult patients hospitalized in an intensive care unit and having an EVD.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Patients of intensive care unit
Other interventionPatients of intensive care unit having an EVD
Patients of surgical intensive care unit
Other interventionPatients of surgical intensive care unit having an EVD.
Treatment groups
No treatment groups listed
Trial outcomes
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.
Time frame
From EVD insertion to removal up to 100 days.Secondary outcomes
1
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.
Time frame
From EVD insertion to removal up to 100 days.2
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.
Time frame
From EVD insertion to removal up to 100 days.3
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.
Time frame
From EVD insertion to day 7.4
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.
Time frame
From EVD insertion to hospital discharge up to 12 months.Sponsors and contacts
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Source ClinicalTrials.gov