CancerWARD-OTNCT06361862
Does Continuous Vital Sign Monitoring Increase Investigations and Interventions in Complication-free Patients?
A study testing Active alarms from WARD software in people with Cancer and Chronic Obstructive Pulmonary Disease, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
This aim of this study is to investigate whether active alerts during CVSM result in an increased number of diagnostic tests and treatments in complication free patients, hypothesizing that more interventions are performed in the CVSM-group than standard of care (EWS) group. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer, Chronic Obstructive Pulmonary Disease, Surgery-Complications
- What is being tested?
- Active alarms from WARD software
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jan 2024to 2 Apr 2025
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- • Patients from WARD - RCT.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Continuous Vital Sign Monitoring Increase Investigations and Interventions in Complication-free Patients? - a Sub-study of Randomized Clinical Trials
This aim of this study is to investigate whether active alerts during CVSM result in an increased number of diagnostic tests and treatments in complication free patients, hypothesizing that more interventions are performed in the CVSM-group than standard of care (EWS) group.
- Being tested
- Active alarms from WARD software
- Medical subject headings
- Neoplasms, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active alarms from WARD softwareDevice
Wireless continuous vital sign monitoring with real time staff alerts
| Study group | Role | What they receive |
|---|---|---|
| inactive alarms | No intervention | Patients with continuous monitoring without active alerts from WARD. |
| active alarms | Experimental | Patients with continuous monitoring with active alerts from WARD. Receives: Device: Active alarms from WARD software |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of patients having at least one of the following tests/treatments:
- CT-scans
- MRi-Scans
- PET-Scans
- X-ray (ordered by attending doctor, besides standard procedural investigations)
- ultrasounds
- Antibiotics (ordered by attending doctor, besides standard procedural treatment)
- Arterial puncture
- Gastro- colonoscopy
- Dialysis
- Central venous line (incl. dialysis catheter)
Measured: 72 hours
Secondary outcomes (1)
The frequency of individual treatments and diagnostics:
Treatments:
- Antibiotics (ordered by attending doctor, besides standard procedural treatment)
- CPAP
- blood-transfusion
- IV-fluids
- Dialysis
- Naso-gastric tube (ordered by attending doctor, besides standard procedural treatment)
- Central venous line (incl. dialysis catheter)
Diagnostics:
- Imaging CT, X-ray, MRI, PET, and ultrasound.
- Blood tests: arterial blood gases, cultures, and other blood sample tests.
- ECG
- cultures from urine, sputum, swabs, and feces.
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2024
- Study start1 Jan 2024
- Primary completion2 Apr 2025
- Study completion2 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 700 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Bispebjerg Hospital
- Responsible party
- Principal investigator, Eske Kvanner Aasvang, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06361862
- Sponsor's protocol ID
- WARD - Overtreatment
- Acronym
- WARD-OT
- Status last verified
- Apr 2025
- First submitted
- 22 Jan 2024
- Last updated
- 6 Apr 2025
- 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 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Continuous Vital Sign Monitoring Increase Investigations and Interventions in Complication-free Patients? - a Sub-study of Randomized Clinical Trials
- ClinicalTrials.gov ID
- NCT06361862
- Acronym / sponsor ID
- WARD-OT / WARD - Overtreatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 700 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Bispebjerg Hospital
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 2 Apr 2025 (actual)
- Study completion
- 2 Apr 2025 (actual)
- First posted
- 12 Apr 2024 (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.
This aim of this study is to investigate whether active alerts during CVSM result in an increased number of diagnostic tests and treatments in complication free patients, hypothesizing that more interventions are performed in the CVSM-group than standard of care (EWS) group.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| inactive alarms | No intervention | –Patients with continuous monitoring without active alerts from WARD. |
| active alarms | Experimental | Device: Active alarms from WARD softwarePatients with continuous monitoring with active alerts from WARD. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- • Patients from WARD - RCT.
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Active alarms from WARD softwareWireless continuous vital sign monitoring with real time staff alerts | Device | active alarms |
Primary outcome
Frequency of patients having at least one of the following tests/treatments:
Time frame: 72 hours
* CT-scans * MRi-Scans * PET-Scans * X-ray (ordered by attending doctor, besides standard procedural investigations) * ultrasounds * Antibiotics (ordered by attending doctor, besides standard procedural treatment) * Arterial puncture * Gastro- colonoscopy * Dialysis * Central venous line (incl. dialysis catheter)
1 secondary outcome
The frequency of individual treatments and diagnostics:
Time frame: 72 hours
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 6 Apr 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active alarms from WARD software in people with Cancer and Chronic Obstructive Pulmonary Disease, run by Copenhagen University Hospital, Rigshospitalet 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 1 inclusion and 1 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 6 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?
Frequency of patients having at least one of the following tests/treatments: (time frame: 72 hours). 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 6 Apr 2025.