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OpenTrials
Completed

NCT Number: NCT04643717

Evaluation of pupillometrY for External Ventricular Drains Stop

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.

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Key information

Conditions

All Indication for External Ventricular Drain Clamping

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital La Timone, Marseille, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Electronic pupillometer analysis

Other

Electronic pupillometer analysis

Primary outcomes

  1. 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

Secondary outcomes

  1. Comparison of the pupillometry parameters between neuro wronged's patients and not neuro wronged's patients (parameters measured by pupillometer)

    Time frame: 48 HOURS

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de la Réunion

Other

Registry information

Acronym: EYES

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Nov 25, 2020
Registry last updated
Nov 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.