Consciousness Prognosis Evaluation Using Olfactory Stimulations in Comatose Patients)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier St Anne

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Olfactory stimulation

Treatment groups

96 Participants
are divided into 1 treatment group

Sponsors and collaborators