Clinical Deterioration
Conditions
Brief summary
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
Interventions
DEVICEWARD CSS
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
Sponsors
Rigshospitalet, Denmark
University Hospital Bispebjerg and Frederiksberg
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
A prospective controlled cohort study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative duration of deviating vital signs, heart rate > 130 min-1 | 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 | 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: SpO2 < 85% min-1 | 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, respiratory rate ≤ 5 min-1 | 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 | 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, heart rate ≤ 30 min-1 | up to 16 days | Cumulative duration in minutes of the following deviations in vital signs during the monitoring period: ● Heart rate ≤ 30 min-1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in vital parameters | up to 16 days | 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) |
| The frequency of events with desaturation as defined below and the simultaneous values of ScO2 | up to 16 days | 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 |
| Events with ScO2 < 60% for ≥ 1 min | up to 16 days | The frequency of events with ScO2 \< 60% for ≥ 1 min and the simultaneous measured SpO2 values |
| Frequency of predefined microevents (deviating vital signs) | up to 16 days | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Duration of vital sign deviation | up to 16 days | Duration of each of the following vital sign deviations * SpO2 \< 85% * Respiratory rate ≤ 5 min-1 * Respiratory rate \> 24 min-1 * Heart rate \> 130 min-1 * Heart rate ≤ 30 min-1 * Lowest ScO2 (mean for ≥ 5 mins) |
| Cumulative duration of ScO2 <60 % during admission | up to 16 days | Cumulative duration of ScO2 \< 60 % related to the total time of NIRS monitoring |
| ECG pattern after alarm | up to 16 days | ECG pattern one hour following an AFLI alarm. (analysed with paired statistics within the continuously monitored group). The ECG pattern one hour following an alarm can be classified as either normal sinusrythm or AFLI |
| Adverse clinical ooutcomes | 6 months | Any adverse clinical outcomes as defined in the protocol |
| Response to an alarm | up to 16 days | Staff response time to an alarm (stratified according to time of day) |
| Contact to the attending doctor on call | up to 16 days | number of times that the attending doctor on call is contacted during admission |
| Contact to intensive care physician on call | up to 16 days | number of times that the intensive care physician on call is contacted during admission |
| Activation of Emergency Response Team | up to 16 days | number of times that the Emergency Response Teams is activated during admission |
| Invasive ventilation | up to 16 days | The frequency of invasive ventilation during admission |
| ICU admissions | up to 16 days | The frequency of ICU admissions during admission |
| Length of stay | up to 16 days | Length of stay (LOS) in days |
Countries
Denmark
Outcome results
None listed