Wearable-based COVID-19 Markers for Prediction of Clinical Trajectories. The WAVE Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Diagnostic accuracy of smartwatch data in predicting ICU requirement in COVID-19 contracted inpatients quantified as the area under the receiver operator characteristics curve (AUC ROC > 0.85).
研究概览
简要总结
The aim is to develop a wearable-based ICU (intensive care unit) prediction algorithm for inpatients contracted with SARS-CoV-2. Inpatients with suspicion of COVID-19 or with confirmed SARS-CoV-2 infection will be included. The participants will be equipped with a smartwatch, which gathers physiological data throughout hospitalisation.
详细描述
The SARS-CoV-2 pandemic puts an unprecedented burden on the healthcare system, specifically its healthcare providers and the resource demands for intensive care units (ICUs). To support effective care despite large case numbers, hospital operations urgently need improved decision support in early identification of patients at risk of an acute COVID-19 deterioration that requires ICU.
The investigators aim at developing a wearable-based ICU algorithm for inpatients contracted with SARS-CoV-2. Inpatients on the general ward with suspicion of COVID-19 or with confirmed SARS-CoV-2 infection will be included. The participant will be equipped with a smartwatch and wear the device throughout the hospital stay until the patient (1) is discharged home, (2) is transferred to the ICU, or (3) palliative care is initiated. The smartwatch collects several physiological parameters (e.g. heart rate, heart rate variability, respiration rate, oxygen saturation). The collected data will be used to develop an ICU prediction algorithm to detect patients at risk of an acute COVID-19 deterioration that requires ICU.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent as documented by signature
- •Age >= 18 years
- •Suspicion of COVID-19 or patient tested positive for SARS-CoV-2
- •Hospitalisation on the general ward
排除标准
- •Smartwatch cannot be attached around the wrist of the patient
- •Direct transfer from the emergency department or external institution to ICU (i.e. no hospitalization on the general ward)
- •Known allergies to components of the smartwatch
- •Rejection of ICU transfer in the patient decree
结局指标
主要结局
Diagnostic accuracy of smartwatch data in predicting ICU requirement in COVID-19 contracted inpatients quantified as the area under the receiver operator characteristics curve (AUC ROC > 0.85).
时间窗: until hospital discharge, transfer to ICU or palliative care is initiated (expected to be on average after 7-30 days)
Accuracy of the WAVE-model will be assessed using physiological data recorded by the smartwatch (Garmin vivoactive 4) during hospitalization complemented by demographic and health-related patient-information and will be analysed using applied machine learning technology for ICU prediction.
次要结局
- Diagnostic accuracy of routine physiological data in predicting ICU requirement in COVID-19 contracted in-patients quantified as the area under the receiver operator characteristics curve (AUC ROC > 0.85).(until hospital discharge, transfer to ICU or palliative care is initiated (expected to be on average after 7-30 days))
- Change of blood oxygen saturation from baseline (hospitalization) to ICU admission(until hospital discharge, transfer to ICU or palliative care is initiated (expected to be on average after 7-30 days))
- Change of sleep pattern from baseline (hospitalization) to ICU admission(until hospital discharge, transfer to ICU or palliative care is initiated (expected to be on average after 7-30 days))
- Change of heart rate variability from baseline (hospitalization) to ICU admission(until hospital discharge, transfer to ICU or palliative care is initiated (expected to be on average after 7-30 days))
- Change of physical activity from baseline (hospitalization) to ICU admission(until hospital discharge, transfer to ICU or palliative care is initiated (expected to be on average after 7-30 days))
- Change of diastolic blood pressure from baseline (hospitalization) to ICU admission(until hospital discharge, transfer to ICU or palliative care is initiated (expected to be on average after 7-30 days))
- Change of base excess from baseline (hospitalization) to ICU admission(until hospital discharge, transfer to ICU or palliative care is initiated (expected to be on average after 7-30 days))
- Diagnostic accuracy of predicting hospital discharge without ICU admission in COVID-19 contracted in-patients quantified as area under the receiver operator characteristics curve(until hospital discharge, transfer to ICU or palliative care is initiated (expected to be on average after 7-30 days))
- Change of respiration rate from baseline (hospitalization) to ICU admission(until hospital discharge, transfer to ICU or palliative care is initiated (expected to be on average after 7-30 days))
- Change of steps per day from baseline (hospitalization) to ICU admission(until hospital discharge, transfer to ICU or palliative care is initiated (expected to be on average after 7-30 days))
- Change of oxygen partial pressure (pO2) from baseline (hospitalization) to ICU admission(until hospital discharge, transfer to ICU or palliative care is initiated (expected to be on average after 7-30 days))
- Change of heart rate from baseline (hospitalization) to ICU admission(until hospital discharge, transfer to ICU or palliative care is initiated (expected to be on average after 7-30 days))
- Change of stress level from baseline (hospitalization) to ICU admission(until hospital discharge, transfer to ICU or palliative care is initiated (expected to be on average after 7-30 days))
- Change of CO2 partial pressure (pCO2) from baseline (hospitalization) to ICU admission(until hospital discharge, transfer to ICU or palliative care is initiated (expected to be on average after 7-30 days))
- Change of blood pH from baseline (hospitalization) to ICU admission(until hospital discharge, transfer to ICU or palliative care is initiated (expected to be on average after 7-30 days))
- Change of skin temperature from baseline (hospitalization) to ICU admission(until hospital discharge, transfer to ICU or palliative care is initiated (expected to be on average after 7-30 days))
- Change of systolic blood pressure from baseline (hospitalization) to ICU admission(until hospital discharge, transfer to ICU or palliative care is initiated (expected to be on average after 7-30 days))
- Change of body temperature from baseline (hospitalization) to ICU admission(until hospital discharge, transfer to ICU or palliative care is initiated (expected to be on average after 7-30 days))
- Change of bicarbonate from baseline (hospitalization) to ICU admission(until hospital discharge, transfer to ICU or palliative care is initiated (expected to be on average after 7-30 days))
- Change of oxygen flow rate from baseline (hospitalization) to ICU admission(until hospital discharge, transfer to ICU or palliative care is initiated (expected to be on average after 7-30 days))