Consciousness Prognosis Evaluation Using Olfactory Stimulations in Comatose Patients) (CEOS)

Centre Hospitalier St Anne

Status: Enrolling

Conditions: Disorders of Consciousness Due to Severe Brain Injury

Treatments: Diagnostic Test: Olfactory stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT07127224

D21-P017

Details and patient eligibility

About

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

Enrollment: 96 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 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)

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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96 participants in 1 patient group

Patients with disorders of consciousness

Experimental group

Description:

Adult ICU patients with disorders of consciousness will undergo non-invasive neurophysiological assessments including olfactory, auditory, and somatosensory stimulations. Olfactory stimuli are added for prognostic evaluation. Clinical and neurological follow-up will be done at 3 months.

Treatment:

Diagnostic Test: Olfactory stimulation