Continuous Monitoring With Real-time Transmission of Vital Signs to Healthcare Professionals From Patients at Home
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 83
- 试验地点
- 1
- 主要终点
- (Re)admission
研究概览
简要总结
The study aims to investigate the use of wireless, continuous monitoring in patients at home including the frequency of alarms triggered by abnormal vital parameters and their significance for (re)hospitalisation/Serious Adverse Events(SAE) and/or death within 30 days.
详细描述
Acute hospital admissions challenge the capacity of the healthcare system. Readmission is common among patients with chronic medical diseases, and many patients admitted for acute conditions are often subsequently observed at the hospital for hours and often with one overnight stay for observation purposes alone. Recent medico technical research has allowed continuous and wireless monitoring of patients' vital signs in-hospital, but the practice at home remains uninvestigated. However, the technology has the potential to relieve hospital overcrowding by offering continuous and real time analytics of vital signs in high-risk patients at home.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (≥18 years) admitted (with at least one night stay) with an acute medical disease and scheduled for discharge to their own homes
- •Adult patients (≥18 years) who have contacted the EMS and, after assessment by paramedic personnel, not deemed sick enough for immediate hospital admission.
排除标准
- •Patients placed on palliative treatment.
- •Acceptable chronically abnormal vital parameters of SpO2<88%, MAP<70, RR>24, or HR>
- •Allergy to plaster, plastic, or silicone.
- •A pacemaker or Implantable Cardioverter Defibrillator (ICD) device.
- •If the patient was deemed not able to open the front door when visited by the investigator.
- •Inability to give informed consent.
结局指标
主要结局
(Re)admission
时间窗: within 30 days
Defined as acute admission to hospital for at least 12 hours with relation to prior discharge or EMS contact
Serious Adverse Events
时间窗: within 30 days
Any adverse event, including acute admissions during the observational period. Criteria defined in protocol. Adverse events will be manually categorised as a 'severe adverse event' (SAE), or simple 'adverse event' (AE).
Mortality
时间窗: within 30 days
次要结局
- (Re)admission(within 7 days after discharge/assessment by paramedic personnel)
- Inquiries to the Emergency Medical Service(within 30 days)
- Mortality and types of SAEs(within 30 days)
研究者
Emilie Sigvardt
Principal investigator
Bispebjerg Hospital