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临床试验/NCT07127224
NCT07127224招募中不适用

Consciousness Prognosis Evaluation Using Olfactory Stimulations in Comatose Patients

Centre Hospitalier St Anne2 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2024年2月5日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
96
试验地点
2
主要终点
Glasgow Outcome Scale-Extended (GOS-E) score at 3 months

研究概览

简要总结

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

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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)

结局指标

主要结局

Glasgow Outcome Scale-Extended (GOS-E) score at 3 months

时间窗: 3 months after inclusion

次要结局

未报告次要终点

研究者

发起方
Centre Hospitalier St Anne
申办方类型
Other
责任方
Sponsor

研究点 (2)

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