Quantitative Pupillometry

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Brief Title

Quantitative Pupillometry

Official Title

Quantitative Pupillometry During External Ventricular Drain Weaning - An Observational Study

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.
    


Study Type

Observational


Primary Outcome

NPi (Neurological Pupil index) and EVD (external ventricular drain)occlusion test

Secondary Outcome

 Diagnostic evaluation

Condition

Hydrocephalus



Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

60

Start Date

May 31, 2022

Completion Date

September 1, 2024

Primary Completion Date

September 1, 2024

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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Jérôme DAUVERGNE, 33 (0) 2.40.16.52.89, [email protected]

Location Countries

France

Location Countries

France

Administrative Informations


NCT ID

NCT05386303

Organization ID

RC21_0078


Responsible Party

Sponsor

Study Sponsor

Nantes University Hospital


Study Sponsor

Jérôme DAUVERGNE, Principal Investigator, CHU de Nantes


Verification Date

May 2021