Back to resultsContinuous Wireless Monitoring of Vital Signs and Automated Alerts of Patient Deterioration in Patients Admitted With COVID-19 Infection (WARD COVID-19)
Primary Purpose
Clinical Deterioration
Status
Terminated
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
WARD CSS
Sponsored by
About this trial
This is an interventional prevention trial for Clinical Deterioration
Eligibility Criteria
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.
Sites / Locations
- Bispebjerg and Frederiksberg Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Monitoring arm
standard Early Warning Score arm
Arm Description
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
Patients in this arm will be monitored with standard Early Warning Score
Outcomes
Primary Outcome Measures
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
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
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
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
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
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
Secondary Outcome Measures
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
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)
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
Events with ScO2 < 60% for ≥ 1 min
The frequency of events with ScO2 < 60% for ≥ 1 min and the simultaneous measured SpO2 values
Full Information
NCT ID
NCT04724681
First Posted
October 21, 2020
Last Updated
May 29, 2023
Sponsor
University Hospital Bispebjerg and Frederiksberg
Collaborators
Rigshospitalet, Denmark
1. Study Identification
Unique Protocol Identification Number
NCT04724681
Brief Title
Continuous Wireless Monitoring of Vital Signs and Automated Alerts of Patient Deterioration in Patients Admitted With COVID-19 Infection
Acronym
WARD COVID-19
Official Title
Continuous Wireless Monitoring of Vital Signs and Automated Alerts of Patient Deterioration in Patients Admitted With COVID-19 Infection
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Terminated
Why Stopped
lack of funding
Study Start Date
November 3, 2020 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Bispebjerg and Frederiksberg
Collaborators
Rigshospitalet, Denmark
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clinical Deterioration
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A prospective controlled cohort study
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
97 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Monitoring arm
Arm Type
Active Comparator
Arm Description
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
Arm Title
standard Early Warning Score arm
Arm Type
No Intervention
Arm Description
Patients in this arm will be monitored with standard Early Warning Score
Intervention Type
Device
Intervention Name(s)
WARD CSS
Intervention Description
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
Primary Outcome Measure Information:
Title
Cumulative duration of deviating vital signs: SpO2 < 85% min-1
Description
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
Title
Cumulative duration of deviating vital signs, respiratory rate ≤ 5 min-1
Description
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
Title
Cumulative duration of deviating vital signs, respiratory rate > 24 min-1
Description
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
Title
Cumulative duration of deviating vital signs, heart rate > 130 min-1
Description
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
Title
Cumulative duration of deviating vital signs, heart rate ≤ 30 min-1
Description
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
Title
Cumulative duration of deviating vital signs, ScO2
Description
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
Secondary Outcome Measure Information:
Title
Frequency of predefined microevents (deviating vital signs)
Description
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
Title
Change in vital parameters
Description
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
Title
The frequency of events with desaturation as defined below and the simultaneous values of ScO2
Description
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
Title
Events with ScO2 < 60% for ≥ 1 min
Description
The frequency of events with ScO2 < 60% for ≥ 1 min and the simultaneous measured SpO2 values
Time Frame
up to 16 days
Other Pre-specified Outcome Measures:
Title
Duration of vital sign deviation
Description
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)
Time Frame
up to 16 days
Title
ECG pattern after alarm
Description
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
Time Frame
up to 16 days
Title
Adverse clinical ooutcomes
Description
Any adverse clinical outcomes as defined in the protocol
Time Frame
6 months
Title
Response to an alarm
Description
Staff response time to an alarm (stratified according to time of day)
Time Frame
up to 16 days
Title
Contact to the attending doctor on call
Description
number of times that the attending doctor on call is contacted during admission
Time Frame
up to 16 days
Title
Contact to intensive care physician on call
Description
number of times that the intensive care physician on call is contacted during admission
Time Frame
up to 16 days
Title
Activation of Emergency Response Team
Description
number of times that the Emergency Response Teams is activated during admission
Time Frame
up to 16 days
Title
Invasive ventilation
Description
The frequency of invasive ventilation during admission
Time Frame
up to 16 days
Title
ICU admissions
Description
The frequency of ICU admissions during admission
Time Frame
up to 16 days
Title
Length of stay
Description
Length of stay (LOS) in days
Time Frame
up to 16 days
Title
Cumulative duration of ScO2 <60 % during admission
Description
Cumulative duration of ScO2 < 60 % related to the total time of NIRS monitoring
Time Frame
up to 16 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katja Grønbæk, MD, PhD-student
Organizational Affiliation
Bispebjerg Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bispebjerg and Frederiksberg Hospital
City
Copenhagen
ZIP/Postal Code
2400
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
Continuous Wireless Monitoring of Vital Signs and Automated Alerts of Patient Deterioration in Patients Admitted With COVID-19 Infection
We'll reach out to this number within 24 hrs