Consciousness Prognosis Evaluation Using Olfactory Stimulations in Comatose Patients)
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An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Olfactory stimulation.
- Who it may be relevant to
- Registry conditions: Disorders of Consciousness Due to Severe Brain Injury. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Consciousness Prognosis Evaluation Using Olfactory Stimulations in Comatose Patients
Overview
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
Interventions
- Diagnostic test Olfactory stimulation
Olfactory stimulation ("sniff" test) combined with auditory and somatosensory stimulations during bedside neurophysiological assessments to evaluate neurological prognosis in ICU patients.
Primary outcome measures
- Glasgow Outcome Scale-Extended (GOS-E) score at 3 months [Time frame: 3 months after inclusion]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
France · 1 center
- GHU Psychiatrie et Neurosciences — Paris
Identifiers
NCT: NCT07127224 · D21-P017