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

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 Overview

• Status: Terminated
• Conditions: Clinical Deterioration
• Intervention / Treatment: Device: WARD CSS

• Study Type: Interventional
• Enrollment (Actual): 97
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2400
    • Bispebjerg and Frederiksberg Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Monitoring arm; 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; 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
No Intervention: standard Early Warning Score arm; Patients in this arm will be monitored with standard Early Warning Score

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of vital sign deviation	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)	up to 16 days
ECG pattern after alarm	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	up to 16 days
Adverse clinical ooutcomes	Any adverse clinical outcomes as defined in the protocol	6 months
Response to an alarm	Staff response time to an alarm (stratified according to time of day)	up to 16 days
Contact to the attending doctor on call	number of times that the attending doctor on call is contacted during admission	up to 16 days
Contact to intensive care physician on call	number of times that the intensive care physician on call is contacted during admission	up to 16 days
Activation of Emergency Response Team	number of times that the Emergency Response Teams is activated during admission	up to 16 days
Invasive ventilation	The frequency of invasive ventilation during admission	up to 16 days
ICU admissions	The frequency of ICU admissions during admission	up to 16 days
Length of stay	Length of stay (LOS) in days	up to 16 days
Cumulative duration of ScO2 <60 % during admission	Cumulative duration of ScO2 < 60 % related to the total time of NIRS monitoring	up to 16 days

Collaborators and Investigators

• Sponsor: University Hospital Bispebjerg and Frederiksberg
• Collaborators: Rigshospitalet, Denmark
• Investigators: Principal Investigator: Katja Grønbæk, MD, PhD-student, Bispebjerg Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 3, 2020
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: October 21, 2020
• First Submitted That Met QC Criteria: January 24, 2021
• First Posted (Actual): January 26, 2021

Study Record Updates

• Last Update Posted (Actual): June 1, 2023
• Last Update Submitted That Met QC Criteria: May 29, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Disease Progression; Clinical Deterioration
• Other Study ID Numbers: H-20025357

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No