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Consciousness Prognosis Evaluation Using Olfactory Stimulations in Comatose Patients)

RecruitingNAAges 18 Years - anyAllCentre Hospitalier St Anne
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In plain words

What the trial is, and whether it could suit you

The goal of this observational study is to determine whether the clinical response to olfactory stimulation (known as the "sniff" response) can help predict 3-month neurological outcomes in ICU patients with persistent disorders of consciousness after sedation withdrawal, regardless of the reason for admission or the initial severity. The main questions this study aims to answer are: * Can the "sniff" response to olfactory stimulation predict neurological outcomes at 3 months? * Is this response a better prognostic indicator than commonly used neurophysiological tests? Researchers will compare the results obtained from olfactory stimulation with those from somatosensory and auditory stimulations to determine whether the olfactory method provides additional or superior prognostic value. Participants will receive additional olfactory stimuli as part of the neurophysiological evaluation

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Admission to neuro-intensive care unit (neuro-ICU) * Age โ‰ฅ 18 years * Patients with persistent disorders of consciousness defined by an abnormal CRS-R score (\<16) at 72 hours after sedation withdrawal and spontaneous ventilation * Consent obtained from legal representatives or activation of emergency waiver * Patient covered by or affiliated with a social security system Exclusion Criteria: * Pregnancy * Brain death * Pre-existing ENT or olfactory bulb pathologies that may affect olfactory functions * Acute or chronic peripheral neurological diseases that may alter evoked potentials * Known neurodegenerative diseases (e.g., Parkinson's disease, Alzheimer's disease) * Patients under legal guardianship or protective supervision (safeguard or protection measures)
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What it tests

  • Olfactory stimulation
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Where

1 site
GHU Psychiatrie et Neurosciences
Paris, France
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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