Continuous Wireless Monitoring of Vital Signs and Automated Alerts of Patient Deterioration in Patients Admitted With COVID-19 Infection

Study Overview
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Brief Summary
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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

Official Title
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Continuous Wireless Monitoring of Vital Signs and Automated Alerts of Patient Deterioration in Patients Admitted With COVID-19 Infection

Conditions
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Clinical Deterioration

Intervention / Treatment
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* Device: WARD CSS


Participation Criteria
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Eligibility Criteria
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Inclusion criteria 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 Exclusion criteria 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A prospective controlled cohort study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Monitoring arm<br>Patients in this arm will have their vital signs monitored with continuous wireless devices and patients in this arm will be monitored with standard Early Warning Score | Device: WARD CSS<br>* Wireless devices monitor vital signs continuously and transmit real-time data to an app that notifies clinical personnel when relevant deviations in vital signs occur This group will be monitored with standard Early Warning Score as well<br>|
| No Intervention: standard Early Warning Score arm<br>Patients in this arm will be monitored with standard Early Warning Score | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative duration of deviating vital signs: SpO2 < 85% min-1 | Cumulative duration in minutes of the following deviations in vital signs during the monitoring period: ● SpO2 < 85% min-1 | up to 16 days | 
| Cumulative duration of deviating vital signs, respiratory rate ≤ 5 min-1 | Cumulative duration in minutes of the following deviations in vital signs during the monitoring period: ● Respiratory rate ≤ 5 min-1 | up to 16 days | 
| Cumulative duration of deviating vital signs, respiratory rate > 24 min-1 | Cumulative duration in minutes of the following deviations in vital signs during the monitoring period: ● Respiratory rate > 24 min-1 | up to 16 days | 
| Cumulative duration of deviating vital signs, heart rate > 130 min-1 | Cumulative duration in minutes of the following deviations in vital signs during the monitoring period: ● Heart rate > 130 min-1 | up to 16 days | 
| Cumulative duration of deviating vital signs, heart rate ≤ 30 min-1 | Cumulative duration in minutes of the following deviations in vital signs during the monitoring period: ● Heart rate ≤ 30 min-1 | up to 16 days | 
| Cumulative duration of deviating vital signs, ScO2 | Cumulative duration in minutes of the following deviations in vital signs during the monitoring period: ● Lowest ScO2 (mean for ≥ 5 mins) min-1 | up to 16 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of predefined microevents (deviating vital signs) | The frequency of micro events (deviating vital signs), measured by continuous vital sign monitoring and as measured by EWS in the control group The microevents are defined as follows, and the the outcome are frequency of these RR ≤5 bpm AND HR >20 bpm RR ≥24 bpm RR <11 bpm AND SpO2 <88 % SpO2 <80% SpO2 <85% SpO2 <88% SpO2 <92% HR >130 bpm HR ≥111 bpm HR <30 bpm HR = 30-40 bpm Atrialflutter | up to 16 days | 
| Change in vital parameters | Change in vital parameters one hour following an alarm as defined below Desaturation • Change in SpO2 60 minutes after an alarm has been triggered. (SpO2 < 85 % for more than 5 minutes, SpO2 < 80 % for more than 1 minutes, SpO2 < 88 % for more than 10 minutes ) Tachypnea • Change in RR 60 minutes after an alarm has been triggered. (RR >24 bpm for more than 5 minutes) Bradypnea/apnea • Change in RR and HR 60 minutes after an alarm has been triggered (RR ≤5 bpm AND HR >20 bpm for more than one minute) Hypoventilation • Change in RR and SpO2 60 minutes after an alarm has been triggered. (RR <11 bpm AND SpO2 <88% for more than 5 minutes ) Tachycardia • Change in HR 60 minutes after an alarm has been triggered. (HR >130 for more than 30 minutes, HR >111 for more than 60 minutes) Bradycardia • Change in HR 60 minutes after an alarm has been triggered. (HR <30 bpm for more than 1 minutes, HR 30-40 bpm for more than 5 minutes) | up to 16 days | 
| The frequency of events with desaturation as defined below and the simultaneous values of ScO2 | The frequency of events with desaturation as defined below and the simultaneous values of ScO2 SpO2 <80% >1 min SpO2 <85% > 5 min SpO2 <88% > 10 min SpO2 <92% > 60 min | up to 16 days | 
| Events with ScO2 < 60% for ≥ 1 min | The frequency of events with ScO2 < 60% for ≥ 1 min and the simultaneous measured SpO2 values | up to 16 days |