Continuous Wireless Vital Parameter MonitoringWARDNCT04305262
Continuous Monitoring of Vital Parameters for Early Detection of Clinical Deterioration in Hospitalized Patients
An observational study of Continuous Wireless Vital Parameter Monitoring, run by University Hospital Bispebjerg and Frederiksberg.
Trial summary
For patients admitted to the medical ward, it is often difficult to predict if 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Continuous Wireless Vital Parameter Monitoring
- What is being tested?
- Wireless continuous vital parameter monitoring
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 25 Mar 2020to 31 Dec 2020
- Phase
- Observational
- 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
Study population: Hospitalized patients at general medical wards, that are in high-risk of deterioration
Who may be able to join
- Adults >18 years
- Acute hospitalization or discharge from Intensive Care Unit (ICU) after an admission of at least 24 hours.
- Early Warning Score (EWS) ≥4 at least once from admission and until inclusion
- One of the following tentative diagnoses as the primary reason for admission: Pneumonia, Dyspnea, Acute myocardial infarction, heartfailure or sepsis
- Inclusion conversation possible within 12 hours of admission or discharge from ICU
Who cannot join
- Patients that cannot cooperate
- Patients that cannot give informed consent
- Patients with EWS≥4 that is not of presumed physical origin
- Patients with allergies to plaster or silicone
- Patients with pacemaker or ICD
- Patients with treatment limitations (no resuscitation or no admission to ICU)
- Patients with expected discharge within 24 hours
- Patients that have been included in the WARD-COPD study (H-18026653)
About this study
Official title: Continuous Monitoring of Vital Parameters for Early Detection of Clinical Deterioration in Hospitalized Patients - a Part of the Wireless Assessment of Respiratory and Circulatory Distress (WARD) Project
For patients admitted to the medical ward, it is often difficult to predict if 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 WARD project aims to determine the correlation between cardiopulmonary micro events and clinical adverse events during the first four days after hospital admission.
- Being tested
- Wireless continuous vital parameter monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wireless continuous vital parameter monitoringDevice
The patients included in this study will have continuous, wireless monitoring of vital parameters during the first four days of acute admission
What is being measured
The primary outcome is the main question the study is designed to answer.
Serious desaturation
SpO2 <85% in 10 consecutive minutes
Measured: more than 10 minutes, within the first four days of acute admission
Secondary outcomes (7)
desaturation
SpO2 <92% in 60 consecutive minutes
Measured: more than 60 minutes, within the first four days of acute admission
tachycardia
Heartrate >130/min
Measured: one minute within the first four days of admission
bradycardia
heartrate >41/min
Measured: one minute within the first four days of admission
tachypnea
Respiration rate >24/min
Measured: one minute within the first four days of admission
bradypnea
Respiration rate <9/min
Measured: one minute within the first four days of admission
hypotension
Systolic blood pressure <90 mmHg
Measured: one measurement within the first four days of admission
hypertension
systolic blood pressure >219 mmHg
Measured: one measurement wihtin the first four days of admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2020
- Study start25 Mar 2020 (estimated)
- Primary completion1 Aug 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Why it stopped: due to COVID-19 is was not possible to complete the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Continuous Wireless Vital Parameter MonitoringStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Bispebjerg and Frederiksberg
- Sponsor type
- University, hospital or other
- Collaborators
- Technical University of Denmark, Bispebjerg Hospital, Copenhagen University Hospital, Rigshospitalet
- Responsible party
- Principal investigator, Katja Kjær Grønbæk, University Hospital Bispebjerg and Frederiksberg
- Investigators
- Christian Meyhoff, MD, PhD, Study chair, Bispebjerg HospitalKatja Grønbæk, MD, Principal investigator, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04305262
- Sponsor's protocol ID
- H-19086056
- Acronym
- WARD
- Status last verified
- Jan 2022
- First submitted
- 9 Mar 2020
- Last updated
- 21 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Monitoring of Vital Parameters for Early Detection of Clinical Deterioration in Hospitalized Patients - a Part of the Wireless Assessment of Respiratory and Circulatory Distress (WARD) Project
- ClinicalTrials.gov ID
- NCT04305262
- Acronym / sponsor ID
- WARD / H-19086056
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: due to COVID-19 is was not possible to complete the study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital Bispebjerg and FrederiksbergUniversity, hospital or other
- Collaborators
- Technical University of Denmark, Bispebjerg Hospital, Copenhagen University Hospital, Rigshospitalet
- Study start
- 25 Mar 2020 (estimated)
- Primary completion
- 1 Aug 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 12 Mar 2020 (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 to the medical ward, it is often difficult to predict if 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 WARD project aims to determine the correlation between cardiopulmonary micro events and clinical adverse events during the first four days after hospital admission.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospitalized patients at general medical wards, that are in high-risk of deterioration
Key inclusion criteria (5 listed)
- Adults >18 years
- Acute hospitalization or discharge from Intensive Care Unit (ICU) after an admission of at least 24 hours.
- Early Warning Score (EWS) ≥4 at least once from admission and until inclusion
- One of the following tentative diagnoses as the primary reason for admission: Pneumonia, Dyspnea, Acute myocardial infarction, heartfailure or sepsis
- Inclusion conversation possible within 12 hours of admission or discharge from ICU
Key exclusion criteria (8 listed)
- Patients that cannot cooperate
- Patients that cannot give informed consent
- Patients with EWS≥4 that is not of presumed physical origin
- Patients with allergies to plaster or silicone
- Patients with pacemaker or ICD
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 |
|---|---|---|
| Wireless continuous vital parameter monitoringThe patients included in this study will have continuous, wireless monitoring of vital parameters during the first four days of acute admission | Device | – |
Primary outcome
Serious desaturation
Time frame: more than 10 minutes, within the first four days of acute admission
SpO2 <85% in 10 consecutive minutes
7 secondary outcomes
desaturation
Time frame: more than 60 minutes, within the first four days of acute admission
tachycardia
Time frame: one minute within the first four days of admission
bradycardia
Time frame: one minute within the first four days of admission
tachypnea
Time frame: one minute within the first four days of admission
bradypnea
Time frame: one minute within the first four days of admission
hypotension
Time frame: one measurement within the first four days of admission
hypertension
Time frame: one measurement wihtin the first four days of admission
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2022.
- Individual participant dataSharing planned: No
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.
Christian Meyhoff, MD, PhD study chair
Bispebjerg Hospital
Katja Grønbæk, MD principal investigator
Bispebjerg Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Continuous Wireless Vital Parameter Monitoring, run by University Hospital Bispebjerg and Frederiksberg.
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 5 inclusion and 8 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: withdrawn, as of the sponsor's last update on 21 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
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 withdrawn before enrolling participants, so there are no results.
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?
Serious desaturation (time frame: more than 10 minutes, within the first four days of acute admission). 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 21 Jan 2022.