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Quantitative Pupillometry

Quantitative Pupillometry During External Ventricular Drain Weaning - An Observational Study

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05386303
Acronym
HYDRO-NiP
Enrollment
60
Registered
2022-05-23
Start date
2022-05-31
Completion date
2024-09-01
Last updated
2022-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Care, Hydrocephalus

Keywords

Pupillometry, External ventricular drain, Weaning, Brain injury, Pupillary reactivity

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.

Interventions

None listed

Sponsors

Nantes University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
NPi (Neurological Pupil index) and EVD (external ventricular drain)occlusion test5 daysNPi 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

MeasureTime frameDescription
Pupillometry and EVD occlusion test5 daysConstriction velocity will be compared between two groups of patients (constituted a posteriori): success and failure of the occlusion test.
Dilatation velocity5 daysDilation velocity will be compared between two groups of patients (constituted a posteriori): success and failure of the occlusion test.
Maximum constriction velocity5 daysMaximum constriction velocity will be compared between two groups of patients (constituted a posteriori): success and failure of the occlusion test.
Diagnostic evaluation5 daysPupillometer 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.
Pupil size variation5 daysPupil size variation will be compared between two groups of patients (constituted a posteriori): success and failure of the occlusion test.
Pupillometry and clinical scores5 daysThe 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 daysA relationship between, measurements of ventricular volumes (via brain imaging examinations performed regardless of this study) and pupillometry parameters will be sought
Latency of contraction5 daysLatency of contraction will be compared between two groups of patients (constituted a posteriori): success and failure of the occlusion test.

Countries

France

Contacts

Primary ContactJérôme DAUVERGNE, IDE
jerome.dauvergne@chu-nantes.fr33 (0) 2.40.16.52.89

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026