Evaluation of pupillometrY for External Ventricular Drains Stop (EYES)

Placement of an external ventricular shunt is one of the most common neurosurgical procedures in neuro-resuscitation. However, the modalities of its withdrawal are not, the subject of recommendations but rather of service habits. It has been recently demonstrated that pupillary monitoring by an electronic pupillometer was more reliable than standard clinical monitoring in brain injury patients. This tool provides access to a rich pupillary semiology at the patient's bed.

So the goal is to study the evolution of the various pupillary parameters analyzed by the electronic pupillometer during the external ventricular shunt weaning tests and to highlight the predictive factors of failure.

Study Overview

Study Type

Observational

Enrollment (Actual)

110

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Marseille, France, 13005
        • Hôpital La Timone
      • Saint-Pierre, France, 97448
        • CHU de la Réunion

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Adult patients who have benefited from an external ventricular bypass, whatever the indication, and for whom the doctor in charge prescribes a clamping test.

Description

Inclusion Criteria:

  • All patients for whom the doctor orders an external ventricular bypass clamp test
  • Neuro-injured patients and non-neuro-injured patients whose state of health requires sedation and mechanical ventilation

Exclusion Criteria:

  • Ophthalmological pathology making impossible to carry out measurements by the pupillometer (chemosis, eyelid edema, enucleation, etc.).
  • Pregnant woman.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
intensive care patients
Electronic pupillometer analysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The difference in pupillary contraction speed during the photomotor reflex measured by electronic pupillometer as a function of the outcome of the External ventricular lead clamping test
Time Frame: 48 HOURS
48 HOURS

Secondary Outcome Measures

Outcome Measure
Time Frame
Comparison of the pupillometry parameters between neuro wronged's patients and not neuro wronged's patients (parameters measured by pupillometer)
Time Frame: 48 HOURS
48 HOURS

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 2, 2018

Primary Completion (Actual)

November 2, 2020

Study Completion (Actual)

November 2, 2020

Study Registration Dates

First Submitted

November 6, 2020

First Submitted That Met QC Criteria

November 19, 2020

First Posted (Actual)

November 25, 2020

Study Record Updates

Last Update Posted (Actual)

November 25, 2020

Last Update Submitted That Met QC Criteria

November 19, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • 2018/CHU/01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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