Quantitative Pupillometry
- Conditions
- HydrocephalusCritical Care
- Registration Number
- NCT05386303
- Lead Sponsor
- Nantes University Hospital
- Brief Summary
The aim of this study is to assess the diagnostic ability of quantitative pupillometry for the early detection of hydrocephalus during the weaning process of the external ventricular drain.
- Detailed Description
Acute hydrocephalus is an emergency often requiring the insertion of an external ventricular drain (EVD). In the aftermath, the patient is transferred to an intensive care unit (ICU) for close monitoring. Ensuring optimal cerebral perfusion through efficient drainage of cerebrospinal fluid while minimizing drainage duration are the objectives of care.
Assessing pupillary light reflex is a key test for the detection of neurological deterioration. For long, this assessment has been grossly performed via a qualitative approach (present/absence of pupillary light reflex). For a more precise assessment, quantitative pupillometry has been proposed. Pupil size and constriction speed in response to a standard light are recorded by an automatic portable and user-friendly device. This device is increasingly used in the ICU, mostly for prognostication after acute brain injury. We hypothesized that quantitative pupillometry parameters may vary when hydrocephalus occurs.
The aim of this study is to assess whether quantitative pupillometry parameters vary when hydrocephalus occurs. The investigators focused on the early detection of hydrocephalus during the EVD weaning process.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 60
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method NPi (Neurological Pupil index) and EVD (external ventricular drain)occlusion test 5 days NPi will be compared between two groups of patients (constituted a posteriori): success and failure of the EVD occlusion test.
Independently of this study, the EDV occlusion test starts as soon as prescribed by the physician as a prerequisite before its withdrawal.
Failing an occlusion test is defined by the need for reopening the EVD.
- Secondary Outcome Measures
Name Time Method Dilatation velocity 5 days Dilation velocity will be compared between two groups of patients (constituted a posteriori): success and failure of the occlusion test.
Latency of contraction 5 days Latency of contraction will be compared between two groups of patients (constituted a posteriori): success and failure of the occlusion test.
Maximum constriction velocity 5 days Maximum constriction velocity will be compared between two groups of patients (constituted a posteriori): success and failure of the occlusion test.
Pupil size variation 5 days Pupil size variation will be compared between two groups of patients (constituted a posteriori): success and failure of the occlusion test.
Diagnostic evaluation 5 days Pupillometer ability to detect an EDV occlusion test failure will be studied. The area under the ROC curve (AUCROC) will be determined. We define, a priori, that the detection performance will be, respectively, honorable, good or excellent if the AUCROC is higher than 0.70, 0.80 and 0.90.
Pupillometry and EVD occlusion test 5 days Constriction velocity will be compared between two groups of patients (constituted a posteriori): success and failure of the occlusion test.
Pupillometry and clinical scores 5 days The association between pupillometry parameters and clinical scores (Glasgow Coma Scale, FOUR score, RASS and CAM-ICU) will be studied
The association between pupillometry parameters and ventricular volume will be studied. 5 days A relationship between, measurements of ventricular volumes (via brain imaging examinations performed regardless of this study) and pupillometry parameters will be sought
Trial Locations
- Locations (2)
Nantes University Hospital
🇫🇷Nant, Loire-Atlantique, France
CHU de Nantes
🇫🇷Nantes, France