Alert Fatigue, Health PersonnelWARDNCT04661748
Automated Alerts of Patient Deterioration vs. Routine Monitoring of High-risk Patients Admitted to Medical Wards
A study testing real time alarm of deviating vital signs in people with Alert Fatigue, Health Personnel and Deterioration, Clinical, run by University Hospital Bispebjerg and Frederiksberg at 1 site in Denmark.
Trial summary
The primary aim of the current study is to assess the effect of continuous wireless vital signs monitoring with generation of real-time alerts compared to blinded monitoring without alerts on the cumulative duration of any severely deviating vital signs in patients admitted to general hospital wards with acute medical… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alert Fatigue, Health Personnel, Deterioration, Clinical
- What is being tested?
- real time alarm of deviating vital signs
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteDenmark
- Study dates
- 7 Jan 2022to 31 Dec 2024
- 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
- Inclusion and randomization possible within 12 hours of fulfilling all other inclusion criteria below.
- Adult patients (≥18 years).
- At least one (additional) expected overnight stay.
- High-risk medical admission, defines as EITHER:
- one or more of the following symptoms or tentative diagnoses: Pneumonia, dyspnea, acute coronary syndrome, new onset heart failure or sepsis WITH two or more of the following deviations in vital signs recorded at one time point within 48 hours of admission:
- Respiratory rate ≥ 21 min-1 or ≤ 7 min-1
Show all 14Show fewer
- Oxygen saturation of arterial hemoglobin ≤ 93 %
- Pulse rate ≥ 111 min-1 or ≤ 40 min-1
- Systolic blood pressure ≤ 100 mmHg or > 200 mmHg
- Temperature > 39 °C or ≤ 35,9 °C
- Any alteration in mental status
- Any oxygen supplementation
- OR
- ○ Discharged from ICU-stay lasting ≥ 24 hours regardless of cause of ICU-admission.
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).
- Planned admission to unit using continuous vital sign monitoring (i.e. an intermediary care/telemetry unit).
- Patients previously enrolled in the studies WARD-COPD (H-18026653) or WARD-Surgery (H-17033535).
- Patients previously enrolled in the surgical ward RCT
- A pacemaker or Implantable Cardioverter Defibrillator (ICD) device.
- Inability to give informed consent.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Bispebjerg and Frederiksberg Hospital
København NV, Region H, 2400
About this study
Official title: Continuous Wireless Monitoring of Vital Signs and Automated Alerts of Patient Deterioration vs. Routine Monitoring of High-risk Patients Admitted to Medical Wards
The primary aim of the current study is to assess the effect of continuous wireless vital signs monitoring with generation of real-time alerts compared to blinded monitoring without alerts on the cumulative duration of any severely deviating vital signs in patients admitted to general hospital wards with acute medical conditions. Patients admitted with medical conditions represents a large and heterogenous group occupying a substantial part of the total in-patient capacity in the Danish hospitals today. The hypothesize is that continuous vital signs monitoring, and real-time alerts will reduce the cumulative duration of severely deviating vital signs.
Read the detailed description
Deterioration of patients on general hospital wards often goes unnoticed for prolonged periods of time. This delay can potentially result in severe adverse outcomes such as cardiopulmonary arrest and need for admission to the intensive care unit (ICU). These complications occur despite the fact that, in most cases, measurable changes in physiological vital signs, could identify patients at risk. Moreover, occurrence of complications increase treatment costs considerably underpinning the rationale of early detection of patient deterioration in both human and economic terms.
Monitoring of vital signs outside of ICU or telemetry units usually relies on intermittent manual assessments performed by clinical staff at intervals of up to 12 hours with the "Early Warning Score (EWS)", "Tidlig Opsporing af Kritisk Sygdom (TOKS)" or similar systems. However, significant deterioration may occur in-between these intervals, which may explain the EWS/TOKS score's proven lack of impact on morbidity and mortality in Danish hospitals.
Recent medico-technical advances have allowed for clinical use of small wireless wear-and-forget devices that continuously monitor various indices of cardiopulmonary status, ambulatory activity, temperature etc. Studies suggest that integration of continuous monitoring into automated patient surveillance systems more often detects cardiorespiratory instability and may decrease number of Emergency Response Team activations, ICU transfers, length of hospital stay, morbidity and mortality but further randomized controlled trials (RCTs) are needed to confirm this. Other advantages may be a decrease in the time required for vital signs measurement and recording compared to routine monitoring and overall health care cost savings with return-on-investment estimates ranging from 127%-1739%.
- Being tested
- real time alarm of deviating vital signs
- Medical subject headings
- Alert Fatigue, Health Personnel, Clinical Deterioration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
real time alarm of deviating vital signsDevice
Intervention consists of actively alerting staff personnel if physiologic vital signs, deviates from certain thresholds
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Active comparator | Active alarms Receives: Device: real time alarm of deviating vital signs |
| no intervention | No intervention | No alarms |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative duration of one or more of the following deviations in vital signs during the first five days of admission or until discharge:
● SpO2 < 85%
Measured: 5 days after inclusion or until discharge
Cumulative duration of one or more of the following deviations in vital signs during the first five days of admission or until discharge:
- Respiratory rate ≤ 5 min-1
- Respiratory rate > 24 min-1
Measured: 5 days after inclusion or until discharge
Cumulative duration of one or more of the following deviations in vital signs during the first five days of admission or until discharge:
- Heart rate > 130 min-1
- Heart rate ≤ 30 min-1
Measured: 5 days after inclusion or until discharge
Cumulative duration of one or more of the following deviations in vital signs during the first five days of admission or until discharge:
- Systolic blood pressure ≤ 90 mmHg
- Systolic blood pressure > 220 mmHg
Measured: 5 days after inclusion or until discharge
Cumulative duration of one or more of the following deviations in vital signs during the first five days of admission or until discharge:
● Atrial fibrillation
Measured: 5 days after inclusion or until discharge
Cumulative duration of one or more of the following deviations in vital signs during the first five days of admission or until discharge:
● Circulatory failure
- Systolic blood pressure < 100 mmHg AND
- Heart rate >110 min-1 (for more than 30 minutes) OR heart rate >130 min-1 (for more than 5 minutes) OR heart rate < 50 (for more than 30 minutes) AND/
Measured: 5 days after inclusion or until discharge
Secondary outcomes (1)
Frequency and duration of deviations in vital signs
Frequency of each of the deviations in vital signs. List of vital signs, and normal limits detailed in protocol
Measured: 5 days after inclusion or until discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2020
- Study start7 Jan 2022
- Primary completion23 Dec 2023
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alert Fatigue, Health PersonnelStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Bispebjerg and Frederiksberg
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet, Odense University Hospital, Aalborg University Hospital, Hvidovre University Hospital
- Responsible party
- Principal investigator, Katja Kjær Grønbæk, University Hospital Bispebjerg and Frederiksberg
- Investigators
- Katja K Grønbæk, MD, Principal investigator, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04661748
- Sponsor's protocol ID
- H-20033246
- Acronym
- WARD
- Status last verified
- May 2023
- First submitted
- 2 Dec 2020
- Last updated
- 11 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2025. 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 vs. Routine Monitoring of High-risk Patients Admitted to Medical Wards
- ClinicalTrials.gov ID
- NCT04661748
- Acronym / sponsor ID
- WARD / H-20033246
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University Hospital Bispebjerg and FrederiksbergUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet, Odense University Hospital, Aalborg University Hospital, Hvidovre University Hospital
- Study start
- 7 Jan 2022 (actual)
- Primary completion
- 23 Dec 2023 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 10 Dec 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.
The primary aim of the current study is to assess the effect of continuous wireless vital signs monitoring with generation of real-time alerts compared to blinded monitoring without alerts on the cumulative duration of any severely deviating vital signs in patients admitted to general hospital wards with acute medical conditions. Patients admitted with medical conditions represents a large and heterogenous group occupying a substantial part of the total in-patient capacity in the Danish hospitals today. The hypothesize is that continuous vital signs monitoring, and real-time alerts will reduce the cumulative duration of severely deviating vital signs.
Detailed description
Deterioration of patients on general hospital wards often goes unnoticed for prolonged periods of time. This delay can potentially result in severe adverse outcomes such as cardiopulmonary arrest and need for admission to the intensive care unit (ICU). These complications occur despite the fact that, in most cases, measurable changes in physiological vital signs, could identify patients at risk. Moreover, occurrence of complications increase treatment costs considerably underpinning the rationale of early detection of patient deterioration in both human and economic terms.
Monitoring of vital signs outside of ICU or telemetry units usually relies on intermittent manual assessments performed by clinical staff at intervals of up to 12 hours with the "Early Warning Score (EWS)", "Tidlig Opsporing af Kritisk Sygdom (TOKS)" or similar systems. However, significant deterioration may occur in-between these intervals, which may explain the EWS/TOKS score's proven lack of impact on morbidity and mortality in Danish hospitals.
Recent medico-technical advances have allowed for clinical use of small wireless wear-and-forget devices that continuously monitor various indices of cardiopulmonary status, ambulatory activity, temperature etc. Studies suggest that integration of continuous monitoring into automated patient surveillance systems more often detects cardiorespiratory instability and may decrease number of Emergency Response Team activations, ICU transfers, length of hospital stay, morbidity and mortality but further randomized controlled trials (RCTs) are needed to confirm this. Other advantages may be a decrease in the time required for vital signs measurement and recording compared to routine monitoring and overall health care cost savings with return-on-investment estimates ranging from 127%-1739%.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Active comparator | Device: real time alarm of deviating vital signsActive alarms |
| no intervention | No intervention | –No alarms |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Inclusion and randomization possible within 12 hours of fulfilling all other inclusion criteria below.
- Adult patients (≥18 years).
- At least one (additional) expected overnight stay.
- High-risk medical admission, defines as EITHER:
- OR
Key exclusion criteria (8 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).
- Planned admission to unit using continuous vital sign monitoring (i.e. an intermediary care/telemetry unit).
- Patients previously enrolled in the studies WARD-COPD (H-18026653) or WARD-Surgery (H-17033535).
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 |
|---|---|---|
| real time alarm of deviating vital signsIntervention consists of actively alerting staff personnel if physiologic vital signs, deviates from certain thresholds | Device | Intervention arm |
Primary outcome
Cumulative duration of one or more of the following deviations in vital signs during the first five days of admission or until discharge:
Time frame: 5 days after inclusion or until discharge
● SpO2 < 85%
Cumulative duration of one or more of the following deviations in vital signs during the first five days of admission or until discharge:
Time frame: 5 days after inclusion or until discharge
* Respiratory rate ≤ 5 min-1 * Respiratory rate > 24 min-1
Cumulative duration of one or more of the following deviations in vital signs during the first five days of admission or until discharge:
Time frame: 5 days after inclusion or until discharge
* Heart rate > 130 min-1 * Heart rate ≤ 30 min-1
Cumulative duration of one or more of the following deviations in vital signs during the first five days of admission or until discharge:
Time frame: 5 days after inclusion or until discharge
* Systolic blood pressure ≤ 90 mmHg * Systolic blood pressure > 220 mmHg
Cumulative duration of one or more of the following deviations in vital signs during the first five days of admission or until discharge:
Time frame: 5 days after inclusion or until discharge
● Atrial fibrillation
Cumulative duration of one or more of the following deviations in vital signs during the first five days of admission or until discharge:
Time frame: 5 days after inclusion or until discharge
● Circulatory failure * Systolic blood pressure < 100 mmHg AND * Heart rate >110 min-1 (for more than 30 minutes) OR heart rate >130 min-1 (for more than 5 minutes) OR heart rate < 50 (for more than 30 minutes) AND/
1 secondary outcome
Frequency and duration of deviations in vital signs
Time frame: 5 days after inclusion or until discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2025.
- Individual participant dataSharing planned: Undecided
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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 K Grønbæk, MD 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 real time alarm of deviating vital signs in people with Alert Fatigue, Health Personnel and Deterioration, Clinical, 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 14 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: finished, as of the sponsor's last update on 11 Apr 2025. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 one or more of the following deviations in vital signs during the first five days of admission or until discharge: (time frame: 5 days after inclusion or until discharge). 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 11 Apr 2025.