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

Not Applicable

Terminated

• Conditions: Clinical Deterioration
• Interventions: Device: WARD CSS

• Registration Number: NCT04724681
• Lead Sponsor: University Hospital Bispebjerg and Frederiksberg

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-21
• Study Start: 2020-11-03
• Study First Submitted QC: 2021-01-24
• Study First Posted: 2021-01-26
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-29
• Last Update Posted: 2023-06-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 97

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Monitoring arm	WARD CSS	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

Primary Outcome Measures

Name	Time	Method
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: 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, 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, 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 Outcome Measures

Name	Time	Method
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
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
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

Trial Locations

Locations (1)

Bispebjerg and Frederiksberg Hospital; 🇩🇰 Copenhagen, Denmark