Continuous Wireless Monitoring of Vital Signs and Automated Alerts of Patient Deterioration in Patients Admitted With COVID-19 Infection
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 97
- 试验地点
- 2
- 主要终点
- Cumulative duration of deviating vital signs, respiratory rate ≤ 5 min-1
研究概览
简要总结
For patients admitted with COVID-19 infection, it is often difficult to predict if or when their clinical condition will deteriorate. However subtle changes in vital signs are usually present 8 to 24 hours before a life-threatening event such as respiratory failure leading to ICU admission, or unanticipated cardiac arrest. Such adverse trends in clinical observations can be missed, misinterpreted or not appreciated as urgent. New continuous and wearable 24/7 clinical vital parameter monitoring systems offer a unique possibility to identify clinical deterioration before patients condition progress beyond the point-of-no-return, where adverse events are inevitable. The primary aim of this study is to test the effect of continuous wireless vital signs monitoring with generation of real-time alerts through a purpose-built GUI, compared to standard EWS monitoring on the cumulative duration of any severely deviating vital signs
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Adult patients (≥18 years).
- •Inclusion possible within 72 hours of admission, OR within 48 hours of discharge from an ICU to a medical ward
- •At least one expected overnight stay.
- •Patient admitted with confirmed COVID-19 infection
排除标准
- •Patient expected not to cooperate with study procedures.
- •Allergy to plaster or silicone.
- •Patients admitted for palliative care only (i.e. no active treatment).
- •Patients previously enrolled in the studies WARD-COPD (H-18026653) or WARD-Surgery (H-17033535).
- •Inability to give informed consent.
结局指标
主要结局
Cumulative duration of deviating vital signs, respiratory rate ≤ 5 min-1
时间窗: up to 16 days
Cumulative duration in minutes of the following deviations in vital signs during the monitoring period: ● Respiratory rate ≤ 5 min-1
Cumulative duration of deviating vital signs, respiratory rate > 24 min-1
时间窗: up to 16 days
Cumulative duration in minutes of the following deviations in vital signs during the monitoring period: ● Respiratory rate \> 24 min-1
Cumulative duration of deviating vital signs: SpO2 < 85% min-1
时间窗: up to 16 days
Cumulative duration in minutes of the following deviations in vital signs during the monitoring period: ● SpO2 \< 85% min-1
Cumulative duration of deviating vital signs, heart rate > 130 min-1
时间窗: up to 16 days
Cumulative duration in minutes of the following deviations in vital signs during the monitoring period: ● Heart rate \> 130 min-1
Cumulative duration of deviating vital signs, ScO2
时间窗: up to 16 days
Cumulative duration in minutes of the following deviations in vital signs during the monitoring period: ● Lowest ScO2 (mean for ≥ 5 mins) min-1
Cumulative duration of deviating vital signs, heart rate ≤ 30 min-1
时间窗: up to 16 days
Cumulative duration in minutes of the following deviations in vital signs during the monitoring period: ● Heart rate ≤ 30 min-1
次要结局
- Change in vital parameters(up to 16 days)
- The frequency of events with desaturation as defined below and the simultaneous values of ScO2(up to 16 days)
- Frequency of predefined microevents (deviating vital signs)(up to 16 days)
- Events with ScO2 < 60% for ≥ 1 min(up to 16 days)
研究者
Katja Kjær Grønbæk
Principal Investigator
University Hospital Bispebjerg and Frederiksberg