Suspended

Abnormal Pupillary Reactivity Detection and Neurological Status in ICU Patients

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Study Aim

This study aims to detect abnormal pupillary reactivity using an electronic pupillometer and assess its relation to the neurological status in ICU patients.

What is being tested

pupillometry data

Other
Who is being recruted

Over 18 Years
+7 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: February 2013
See protocol details

Summary

Principal SponsorAssistance Publique Hopitaux De Marseille
Last updated: September 1, 2014
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2013

Actual date on which the first participant was enrolled.

This study focuses on the monitoring of brain-damaged patients in intensive care units (ICU). Specifically, it looks at how the pupils react to light, as this can be a sign of a patient's neurological condition getting worse. Currently, this check is done by healthcare professionals, but it can be subjective and not always reliable. The study uses a special device called an electronic pupillometer, which provides a more accurate and consistent measurement of the pupil's response to light. The goal is to see if this device can help detect early signs of a patient's condition worsening. During the study, patients in the ICU will have their pupils checked using the electronic pupillometer. The results will be compared between two groups of patients: those whose condition has worsened and those whose condition has not. This comparison will be done within the first 5 days of treatment, which is considered the highest risk period for patients with brain damage. The main goal is to understand how well the electronic pupillometer can predict a patient's neurological condition getting worse by looking at changes in the pupil's size. The study will last for 14 months and will involve 90 patients.

NCT01796886
Principal SponsorAssistance Publique Hopitaux De Marseille
Last updated: September 1, 2014
Sourced from a government-validated database.Claim as a partner

Protocol

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

90 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

4 inclusion criteria required to participate
Admission in resuscitation within first 48 hours of the aggression
Patients cérébro - hurt presenting disorders(confusions) of the consciousness (Score of Glasgow < 9) and justifying an hourly pupillary surveillance(supervision) in the middle of neurosurgical resuscitation. (Definition of the Score of Glasgow in appendix)
acute(sharp) intellectual Aggression bound(connected) to a cranial trauma, a meningeal bleeding by break of anévrysme, a cerebral vascular accident, an intra-cranial expansive process, a post-operative neurosurgical complication, an intra-cranial high blood pressure of medical origin (méningo-encephalitis, hypertensive encephalopathy)
male or feminine Subjects of 18 or more years old
3 exclusion criteria prevent from participating
Subject having a direct eye trauma, as well as any history which can affect(allocate) the relevance of the pupillary examination (anophthalmia, cataract(waterfall) opalescente, surgery irienne, blindness, reached(affected) by III prerequisite, that the character of these affections is bilateral or unilateral)
minor Subject, pregnant or breast-feeding woman, subject deprived of freedom, subject not being affiliated to the national insurance scheme
presenting Subject of the signs of irreversible coma in the admission

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Assistance Publique Hopitaux de Marseille

Marseille, FranceOpen Assistance Publique Hopitaux de Marseille in Google Maps
SuspendedOne Study Center