Clinical trial NCT05386303: Quantitative Pupillometry
Official title: Quantitative Pupillometry During External Ventricular Drain Weaning - An Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hydrocephalus
Critical Care
Keywords: Pupillometry
External ventricular drain
Weaning
Brain injury
Pupillary reactivity
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2022-05-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult ICU patients with an EVD included at the beginning of the weaning process

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.

Eligibility criteria: Inclusion Criteria :

* Patient older than 18 years old
* Admitted to the ICU
* With an external ventricular drain
* Consenting to participate (or consent from his/her next of kin, if unable to consent).

Exclusion Criteria :

* Patient with pre-existing bilateral pupillary pathology
* Pregnant or breast-feeding patient
* Moribund patient or patient with decision of withholding or withdrawing life-sustaining treatment
* Patient with no health insurance
* Patient under guardianship

Primary outcomes:
measure: NPi (Neurological Pupil index) and EVD (external ventricular drain)occlusion test
timeFrame: 5 days
Secondary outcomes:
measure: Diagnostic evaluation
timeFrame: 5 days
measure: Pupillometry and EVD occlusion test
timeFrame: 5 days
measure: Dilatation velocity
timeFrame: 5 days
measure: Maximum constriction velocity
timeFrame: 5 days
measure: Latency of contraction
timeFrame: 5 days
measure: Pupil size variation
timeFrame: 5 days
measure: Pupillometry and clinical scores
timeFrame: 5 days
measure: The association between pupillometry parameters and ventricular volume will be studied.
timeFrame: 5 days
Other outcomes:
Locations:
city: Nant
country: France
facility: Nantes University Hospital
state: Loire-Atlantique
city: Nantes
country: France
facility: CHU de Nantes
Study officials:
affiliation: Nantes University Hospital
name: Jérôme DAUVERGNE
role: PRINCIPAL_INVESTIGATOR
References: