Informations générales (source: ClinicalTrials.gov)
Evaluation of the Clinical and Electrophysiological Responses of the Brainstem in Patients With Alteration of Consciousness in Relation or Not With Sedation: Prognostic Study of Brain Reflexes (PRORETRO)
Interventional
N/A
Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)
juillet 2015
mai 2019
29 juin 2024
Severe diseases in intensive care unit (ICU) patients are associated with a high
mortality rate which nevertheless remains difficult to predict. Recently, the abolition
of some brainstem reflexes at clinical examination of ICU patients within the first 24
hours after has been shown of prognostic value in ICU patients requiring sedation. Early
abolition of the cough reflex was associated with an increase in mortality and that of
the oculocephalic reflex was predictive of coma or delirium after sedation has been
stopped. A dysfunction of the brainstem may account for these results and be present in
other patient subpopulations, particularly those who do not receive iv sedation or the
brain injured patients, who were eluded from the previous study. This dysfunction could
take place in the muti-organ failure characteristic of the severe ICU patient. On the
other hand, a preliminary study performed on somatosensory evoked potentials has shown
that a latency of the P14 wave greater than 16 ms between day 1 and day 3 after admission
was associated with death at 28 days. The primary goal of this project is to confirm this
hypothesis. By studying the clinical and electrophysiological responses of the brainstem
in ICU patients, with or without brain injury, with alteration of consciousness in
relation or not with sedation. The other objectives are to determine the correlations
between neurophysiological clinical neurological, or neuroradiological data with delirium
occurrence.
The main objective of this study is to determine, in ICU patients with or without brain
injury and with alteration of consciousness in relation or not with sedation, if
abolition of the cough reflex at Day 1 after admission is predictive of mortality at 28
days, independent from cause for admission and severity.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| HOPITAL NORD VILLENEUVE LA GARENNE 92 | Jean Mantz, MD PhD | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- Adult Medical or surgical, brain-injured or not, patients
- Admitted to the intensive care Unit (ICU)
- Requiring invasive mechanical ventilation for at least 48 hours
- With alteration of consciousness induced by sedatives or not
- Within the 24 hours (± 12) after admission into the ICU
- Adult Medical or surgical, brain-injured or not, patients
- Admitted to the intensive care Unit (ICU)
- Requiring invasive mechanical ventilation for at least 48 hours
- With alteration of consciousness induced by sedatives or not
- Within the 24 hours (± 12) after admission into the ICU
- Pregnancy
- Post anoxic coma
- Brain death
- Pre-existing neurologic disease disturbing the interpretation of the brainstem
reflexes (Guillain-Barre, myasthenia, gravis, brain tumor, inflammatory or
degenerating disease of the posterior fossa, acute peripheral neurologic disease)
- Declined participation