Continuous Wireless Monitoring of Vital Signs and Automated Alerts of Patient Deterioration in Patients Admitted With COVID-19 Infection
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Clinical Deterioration
- Sponsor
- University Hospital Bispebjerg and Frederiksberg
- Enrollment
- 97
- Locations
- 1
- Primary Endpoint
- Cumulative duration of deviating vital signs, respiratory rate ≤ 5 min-1
- Status
- Terminated
- Last Updated
- 2 years ago
Overview
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
Investigators
Katja Kjær Grønbæk
Principal Investigator
University Hospital Bispebjerg and Frederiksberg
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Cumulative duration of deviating vital signs, respiratory rate ≤ 5 min-1
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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 Outcomes
- 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)