Quantitative Pupillometry

NCT ID: NCT05386303

Last Updated: 2022-05-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-31

Study Completion Date

2024-09-01

Brief Summary

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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

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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.

Conditions

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Hydrocephalus Critical Care

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nantes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jérôme DAUVERGNE

Role: PRINCIPAL_INVESTIGATOR

Nantes University Hospital

Locations

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Nantes University Hospital

Nant, Loire-Atlantique, France

Site Status

CHU de Nantes

Nantes, , France

Site Status

Countries

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France

Central Contacts

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Jérôme DAUVERGNE, IDE

Role: CONTACT

33 (0) 2.40.16.52.89

Facility Contacts

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Jérôme DAUVERGNE, IDE

Role: primary

33 (0) 2.40.16.52.89

Jérôme Dauvergne

Role: primary

Other Identifiers

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RC21_0078

Identifier Type: -

Identifier Source: org_study_id

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