Telemonitoraggio Domiciliare Della Saturazione Arteriosa di Ossigeno in Pazienti COVID-19
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Number of patients without missing days of telemonitoring/total patients
研究概览
简要总结
The COVID-19 pandemic created an urgent need to implement digital health solutions for remote clinical management of infected patients who could be monitored at home. The Gemelli Polyclinic in Rome provided a digital health program (SATCOV) to monitor at home newly diagnosed COVID-19 patient, or after an early discharge from the COVID units.
A digital application and a wireless oximeter were provided to patients. Oxygen saturation, heart rate and body temperature were monitored. The aim is to evaluate the feasibility and safety of the oxygen saturation telemonitoring in COVID-19 patients.
Clinicians personalized their remote assistance defining specific alerts for each patient and/or required a timely hospitalization in a dedicated COVID unit if necessary.
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 (age>18)
- •confirmed diagnosis of Sars-CoV-2 infection by a positive nasopharyngeal and oropharyngeal swab (PCR or rapid test)
- •clinical condition compatible with hospital discharge (for recoving COVID group) or home management (for ongoing COVID group)
排除标准
- •non-autonomous patients
- •patients without a smartphone and home internet connection
- •patients unable to refer to emergency room in less than 2 hours or unable to observe home isolation
- •the presence of severe comorbidities that could compromise the safety of telemonitoring
结局指标
主要结局
Number of patients without missing days of telemonitoring/total patients
时间窗: 14 days
Number of patients without missing days of telemonitoring/total patients
次要结局
- Number of subject hospitalized/total patients(3 yars)
- Oxygen saturation measurements(14 days)
- Cost efficacy(14 days)
- Descriptive statistics(14 days)
- Correlation between the number of comorbidities and smoking status and SpO2 nadir(14 days)
研究者
RICHELDI LUCA
Professor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS