RecruitingNot ApplicableNCT07127224

Consciousness Prognosis Evaluation Using Olfactory Stimulations in Comatose Patients)

Consciousness Prognosis Evaluation Using Olfactory Stimulations in Comatose Patients


Sponsor

Centre Hospitalier St Anne

Enrollment

96 participants

Start Date

Feb 5, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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 for prognostic purposes and be followed up at 3 months for clinical, neurological, and functional evaluation


Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • Admission to neuro-intensive care unit (neuro-ICU)
  • Age ≥ 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 Criteria6

  • 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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Interventions

DIAGNOSTIC_TESTOlfactory stimulation

Olfactory stimulation ("sniff" test) combined with auditory and somatosensory stimulations during bedside neurophysiological assessments to evaluate neurological prognosis in ICU patients.


Locations(1)

GHU Psychiatrie et Neurosciences

Paris, GHU Psychiatrie Et Neurosciences, France

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NCT07127224


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