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
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
97
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
Bispebjerg and Frederiksberg Hospital
Copenhagen, Denmark
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: up to 16 days
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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: up to 16 days
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