NCT03464721已完成不适用
Usability of SMART ANGEL Medical Device to Record and Transmit Health Data From Patient's Home Following Outpatient Surgery
Centre Hospitalier Universitaire de Nīmes2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年5月14日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Number of measures recorded using tablet for blood pressure, cardiac frequency and oxygen saturation
研究概览
简要总结
This study represents the first step for testing this device in patients in real-life situations to evaluate the technological capacities and usability by the patient
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient must have given their free and informed consent and signed the consent form
- •The patient must be a member or beneficiary of a health insurance plan
- •The patient is at least 18 years old and less than 80 years old
- •The patient is undergoing orthopedic (shoulder, foot, knee), digestive (gallbladder) or gynecological (uterus-ovary) adjustment outpatient surgery
- •The patient has sufficient cognitive and intellectual ability to use the system
- •The patient must undergo a training test during consultation to use the tablet and perform the measurements
- •The patient must have access to 4G at home.
排除标准
- •The subject is participating in an interventional study, or is in a period of exclusion determined by a previous study
- •The subject refuses to sign the consent
- •It is impossible to give the subject informed information
- •The patient is under safeguard of justice or state guardianship
- •The patient is pregnant
- •The patient needs emergency surgery
- •The patient has a level 4 or 5 ASA psychological class
- •Patient cannot have outpatient surgery for medical reasons (decompensated medical pathology), or social reasons according the the SFAR (société française anesthésie réanimation) criteria. Patient alone at home and geographically far from a hospital >30km (or >45 minutes by car).
研究组 & 干预措施
Surgery Outpatients
Experimental
干预措施: issued with SMART ANGEL device (Device)
结局指标
主要结局
Number of measures recorded using tablet for blood pressure, cardiac frequency and oxygen saturation
时间窗: Day 5
Data collected and transmitted
Concordance between data collected on tablet versus paper copies
时间窗: Day 5
Percentage correct measures
次要结局
- Qualitative decision-making ability from pooled results of all data from all patients on readmittance rate(End of inclusion period: Month 18)
- Ease of use of medical device according to patient(Day 5)
- Qualitative decision-making ability from pooled results of all data from all patients(End of inclusion: Month 18)
- Readmission rate(Month 1)
研究者
研究点 (2)
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