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
- 否
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
研究点 (2)
Loading locations...
相似试验
已完成
不适用
The Effects of Olfactory Stimulation on Diagnosis and Prognosis of DOC PatientsMinimally Conscious StateVegetative StateNCT03732092Jing Wang20
招募中
不适用
Olfactory Cleft Obstruction and Electrophysiological Field Potentials Predict Olfactory Restoration by Dupilumab in CRSwNP Patients.NCT06892704Northwestern University30
招募中
不适用
Prognostic Potential of Olfactory Function in Glioblastoma: a Prospective Observational StudyNCT06954636Sied Kebir128
已完成
不适用
Exhaled Breath Olfactory Signature of Pulmonary Arterial HypertensionPulmonary HypertensionNCT02782026Assistance Publique - Hôpitaux de Paris273
已完成
不适用
The evaluation of the efficacy of olfactory stimulation as a means of improving cognitive function: A randomised controlled trialJPRN-UMIN000032936Keio University School of Medicine120
