Clinical DeteriorationWARD COVID-19NCT04724681
Continuous Wireless Monitoring of Vital Signs and Automated Alerts of Patient Deterioration in Patients Admitted With COVID-19 Infection
A study testing WARD CSS in people with Clinical Deterioration, run by University Hospital Bispebjerg and Frederiksberg at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clinical Deterioration
- What is being tested?
- WARD CSS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteDenmark
- Study dates
- 3 Nov 2020to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Conditions
- Clinical Deterioration
- Being tested
- WARD CSS
- Medical subject headings
- Clinical Deterioration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WARD CSSDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Monitoring arm | Active comparator | 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 Receives: Device: WARD CSS |
| standard Early Warning Score arm | No intervention | Patients in this arm will be monitored with standard Early Warning Score |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: up to 16 days
Secondary outcomes (4)
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
Measured: 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)
Measured: 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
Measured: 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
Measured: up to 16 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2021
- Study start3 Nov 2020
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Why it stopped: lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical DeteriorationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- A prospective controlled cohort study
- Masking
- None (open label)
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Bispebjerg and Frederiksberg
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet
- Responsible party
- Principal investigator, Katja Kjær Grønbæk, University Hospital Bispebjerg and Frederiksberg
- Investigators
- Katja Grønbæk, MD, PhD-student, Principal investigator, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04724681
- Sponsor's protocol ID
- H-20025357
- Acronym
- WARD COVID-19
- Status last verified
- May 2023
- First submitted
- 21 Oct 2020
- Last updated
- 1 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Wireless Monitoring of Vital Signs and Automated Alerts of Patient Deterioration in Patients Admitted With COVID-19 Infection
- ClinicalTrials.gov ID
- NCT04724681
- Acronym / sponsor ID
- WARD COVID-19 / H-20025357
- Conditions
- Clinical Deterioration
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of funding
- Enrolment
- 97 participants (actual)
- Lead sponsor
- University Hospital Bispebjerg and FrederiksbergUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet
- Study start
- 3 Nov 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 26 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A prospective controlled cohort study
| Arm | Type | Receives |
|---|---|---|
| Monitoring arm | Active comparator | Device: WARD CSSPatients 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 |
| standard Early Warning Score arm | No intervention | –Patients in this arm will be monitored with standard Early Warning Score |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WARD CSSWireless 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 | Device | Monitoring arm |
Primary outcome
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, 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, 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, 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
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
4 secondary outcomes
Frequency of predefined microevents (deviating vital signs)
Time frame: up to 16 days
Change in vital parameters
Time frame: up to 16 days
The frequency of events with desaturation as defined below and the simultaneous values of ScO2
Time frame: up to 16 days
Events with ScO2 < 60% for ≥ 1 min
Time frame: up to 16 days
Results and safety
The study was stopped early (reason given: lack of funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2023.
Related trials for Clinical Deterioration
Recruiting
The Orientation Intervention to Rapid Response Teams (ORIENT-RRT) Study: A Quasi-Experimental Study
Deterioration, Clinical
Not yet recruiting
MAGICS - Multi-Agent Generative AI in Clinical Simulation for Clinical Deterioration Training
Clinical Reasoning in Nursing Education, Virtual Simulation
RecruitingObservational study
The ReTAVI Prospective Observational Registry
Structural Valve Deterioration, Structural Valve Degeneration
RecruitingObservational study
Repeated Examinations for Typing Pulmonary Embolism
Pulmonary Embolism (Diagnosis), Pulmonary Embolism Acute
Not yet recruitingObservational study
Development and Internal Validation of a Multimodal Prediction Score for Early Hemodynamic Deterioration in Adult Polytrauma Patients
Multiple Trauma, Polytrauma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katja Grønbæk, MD, PhD-student principal investigator
Bispebjerg Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WARD CSS in people with Clinical Deterioration, run by University Hospital Bispebjerg and Frederiksberg at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: lack of funding). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative duration of deviating vital signs: SpO2 < 85% min-1 (time frame: up to 16 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2023.