NCT04194788已完成不适用
Prospective Observational Pilot Study on Olfaction Alterations That Occur in Spine Patients After Surgery
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2021年4月29日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Changes in olfaction threshold
研究概览
简要总结
This observational prospective study evaluates perioperative olfaction alterations, comprising changes in threshold value, discrimination and identification, which occur in spine patients. The single group is subjected to a preoperative and a postoperative assessment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males or females
- •Caucasian race
- •Between 50 and 85 years of age
- •Candidates to spine surgery
- •Acceptance and signing of informed consent
排除标准
- •Past or present cancer
- •Heart failure
- •Kidney failure (III-IV)
- •Past or present neuropsychiatric disorders
- •Heavy smokers (over/equal 3 cigarettes per day)
- •Smell disorders
- •Allergies to the respiratory system
结局指标
主要结局
Changes in olfaction threshold
时间窗: Day before surgery and first day after surgery
Changes in the olfaction threshold evaluated with a series of solutions having different concentrations of aromas
次要结局
未报告次要终点
研究者
研究点 (1)
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