Brain-damaged Patients Clinical Trial
Official title:
Performance Evaluation of Pupillary Reactivity in Monitoring of Brain-damaged Patients in Intensive Care
The pupillary examination is a major component of the clinical examination and monitoring of
brain-damaged patients in intensive care. The occurrence of abnormal size or pupillary
reactivity is a prognostic factor of poor neurological outcome or an indicator of the
neurological status degradation. To date, the monitoring of the pupils is clinical. The
subjectivity of this measure and, the lack of reproducibility and definition of the
abnormality remain as many obstacles to the development of a monitoring of early
neurological deterioration. The recent development in pupillometer electronics allows the
assessment of responsiveness to a calibrated light stimulus. It offers a reliable and
reproducible measure of the pupil diameter. The pupillometers were funded by the association
of " Gueules Cassées ".
This study aims to establish a relationship between an abnormal pupillary reactivity
detection by the electronic pupillometer and a deterioration in neurological status of the
patient brain-damaged in the intensive-care unit (ICU). This is considered clinically
relevant and has been defined by a lower Glasgow Coma Score of at least 2 points for 2 hours
or involving a therapeutic action. If this relationship is demonstrated, the temporal
relationship between data pupillometry and the patient's neurological status remain to be
established more precisely. This is particularly relevant in neurosurgical context and aim
to define the status of the electronic pupillometer in intensive care but also in emergency
rooms services, the neurovascular units or in the pre-hospital care.
Therefore the investigators will compare the pupillometry data in two patients groups,
defined accordingly to the appearance or absence of neurological aggravation in the first 5
days of treatment in intensive care, time-frame defined as the maximum risk period in
patients with brain damage. The primary endpoint is represented by the estimated area under
the ROC curve corresponding to the last measure of the change in pupil size before the onset
of neurological deterioration and worse for the fifth day for non-aggravated.
Thus the investigators propose to conduct a prospective trial, aiming to record the
diagnostic value of pupillary reactivity by the electronic pupillometer in the monitoring of
the neurological aggravation of brain damaged patient in ICU. The duration of the follow-up
for a subject does not exceed 5 days. The statistical analysis requires the recruitment of
90 patients, which sets the length of the inclusions to 14 months.
| Status | Active, not recruiting |
| Enrollment | 90 |
| Est. completion date | November 2014 |
| Est. primary completion date | September 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - male or feminine Subjects of 18 or more years old. - 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) - Admission in resuscitation within first 48 hours of the aggression Exclusion Criteria: - 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). - presenting Subject of the signs of irreversible coma in the admission. - minor Subject, pregnant or breast-feeding woman, subject deprived of freedom, subject not being affiliated to the national insurance scheme. |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| France | Assistance Publique Hopitaux de Marseille | Marseille |
| Lead Sponsor | Collaborator |
|---|---|
| Assistance Publique Hopitaux De Marseille |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | electronic pupillometer | pupillary reactivity | 14 months | No |
| Secondary | Glasgow Coma Score | deterioration in neurological status | 14 months | No |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT03181373 -
IRM Cognition in Patients With Head Trauma
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N/A |