Complication,PostoperativeWARD-RCT-SXNCT04640415
Continuous Wireless Monitoring of Vital Signs and Automated Alerts of Postsurgical Patient Deterioration.
A study testing Active Alarms in people with Complication,Postoperative, run by Copenhagen University Hospital, Rigshospitalet at 2 sites in Denmark.
Trial summary
The primary aim of the current study is to assess the effect of continuous wireless vital sign 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 after major… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Complication,Postoperative
- What is being tested?
- Active Alarms
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 2 sitesDenmark
- Study dates
- 11 Jan 2021to 30 May 2023
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Admission for acute or elective major abdominal (laparotomy/laparoscopy), major orthopedic, major urologic, or arterial vascular surgery.
- Estimated duration of surgery ≥2 hours and at least two expected overnight stays.
- Randomization and commencement of continuous wireless monitoring possible within 24 hours postoperatively
Who cannot join
- Patient expected not to cooperate with study procedures.
- Allergy to plaster or silicone.
- Impaired cognitive function (in uncertain cases assessed by a Mini Mental State Examination] score < 24)
- 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 medical WARD RCT.
- Patients with a pacemaker or Implantable Cardioverter Defibrillator (ICD) device.
- Inability to give informed consent.
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Rigshospitalet
Copenhagen, 2100
Bispebjerg Hospital
Copenhagen NV, Copenhagen, 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 After Major Surgery. A Randomized Controlled Trial.
The primary aim of the current study is to assess the effect of continuous wireless vital sign 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 after major surgery.
We hypothesize that continuous vital signs monitoring, and real-time alerts will reduce the cumulative duration of severely deviating vital signs.
- Conditions
- Complication,Postoperative
- Being tested
- Active Alarms
- Keywords
- Wireless Monitoring, Vital signs, Physiologic deterioration
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active AlarmsDevice
Intervention consists of actively alerting staff personnel if physiologic vital signs, deviates from certain thresholds for more than a set duration. Continuous vital sign data will also be available to clinical staff.
| Study group | Role | What they receive |
|---|---|---|
| No alarms | No intervention | Patients will be connected to monitoring equipment, registering vital sign data, but data will be blinded to clinical staff. |
| Active alarms | Active comparator | Patients will be connected to monitoring equipment, registering data, and data will be available to clinical staff, including alarms for vital sign deterioration. Receives: Device: Active Alarms |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative duration
Cumulative duration of one or more deviations in vital signs. List of vital signs, and normal limits detailed in protocol.
Measured: During monitoring, for a maximum of up to 5 postoperative days or until discharge.
Secondary outcomes (3)
Frequency of sustained deviation alerts
Frequency of each of the sustained deviations in vital signs. List of vital signs, and normal limits detailed in the protocol.
Measured: During monitoring, for a maximum of up to 5 postoperative days or until discharge.
Any adverse event
Any adverse event. Criteria for each defined in protocol. Results will be compared between the case and control arm, on when it a diagnosis is made.
Based on information in patient electronic medical file.
Measured: 7 days and 30 days after start of monitoring
Any serious adverse event
Any serious adverse event. Criteria for each defined in protocol. Serious Adverse Events will be determined using the criteria as defined in ICH-GCP terms.
Results will be compared between the case and control arm, on when it a diagnosis is made.
Based on information in patient electronic medical file.
Measured: 7 days and 30 days after start of monitoring
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2020
- Study start11 Jan 2021
- Primary completion30 Oct 2022
- Study completion30 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Complication,PostoperativeStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital, Odense University Hospital, Bispebjerg Hospital, Technical University of Denmark
- Responsible party
- Principal investigator, Jesper Mølgaard, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Jesper Mølgaard, MD, Principal investigator, Copenhagen University Hospital, RigshospitaletEske K Aasvang, MD, DMSc, Study chair, Copenhagen University Hospital, RigshospitaletChristian S Meyhoff, MD, PhD, Study chair, Bispebjerg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04640415
- Sponsor's protocol ID
- H-20034555
- Acronym
- WARD-RCT-SX
- Status last verified
- Jun 2023
- First submitted
- 12 Nov 2020
- Last updated
- 18 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Larsen AT, Sopina L, Molgaard J, Aasvang EK, Meyhoff CS, Kjellberg J, Kristensen SR. Impact of postoperative in-hospital continuous vital sign monitoring on healthcare costs, resource utilization and labor market outcomes. Eur J Health Econ. 2026 Apr 6. doi: 10.1007/s10198-026-01919-2. Online ahead of print.
PubMed 41941065Molgaard J, Gronbaek KK, Rasmussen SS, Eiberg JP, Jorgensen LN, Achiam MP, Rohrsted M, Singh UM, Hoang TH, Sogaard M, Meyhoff CS, Aasvang EK. Continuous Vital Sign Monitoring at the Surgical Ward for Improved Outcomes After Major Noncardiac Surgery: A Randomized Clinical Trial. Anesth Analg. 2025 Oct 1;141(4):807-817. doi: 10.1213/ANE.0000000000007606. Epub 2025 Jul 1.
PubMed 40591492
Study at a glance
From the registry record, last updated by the sponsor on 18 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 vs. Routine Monitoring of High-risk Patients After Major Surgery. A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT04640415
- Acronym / sponsor ID
- WARD-RCT-SX / H-20034555
- Conditions
- Complication,Postoperative
- Keywords
- Wireless Monitoring, Vital signs, Physiologic deterioration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Aarhus University Hospital, Odense University Hospital, Bispebjerg Hospital, Technical University of Denmark
- Study start
- 11 Jan 2021 (actual)
- Primary completion
- 30 Oct 2022 (actual)
- Study completion
- 30 May 2023 (actual)
- First posted
- 23 Nov 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 sign 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 after major surgery.
We hypothesize that continuous vital signs monitoring, and real-time alerts will reduce the cumulative duration of severely deviating vital signs.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No alarms | No intervention | –Patients will be connected to monitoring equipment, registering vital sign data, but data will be blinded to clinical staff. |
| Active alarms | Active comparator | Device: Active AlarmsPatients will be connected to monitoring equipment, registering data, and data will be available to clinical staff, including alarms for vital sign deterioration. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Admission for acute or elective major abdominal (laparotomy/laparoscopy), major orthopedic, major urologic, or arterial vascular surgery.
- Estimated duration of surgery ≥2 hours and at least two expected overnight stays.
- Randomization and commencement of continuous wireless monitoring possible within 24 hours postoperatively
Key exclusion criteria (8 listed)
- Patient expected not to cooperate with study procedures.
- Allergy to plaster or silicone.
- Impaired cognitive function (in uncertain cases assessed by a Mini Mental State Examination] score < 24)
- 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).
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 AlarmsIntervention consists of actively alerting staff personnel if physiologic vital signs, deviates from certain thresholds for more than a set duration. Continuous vital sign data will also be available to clinical staff. | Device | Active alarms |
Primary outcome
Cumulative duration
Time frame: During monitoring, for a maximum of up to 5 postoperative days or until discharge.
Cumulative duration of one or more deviations in vital signs. List of vital signs, and normal limits detailed in protocol.
3 secondary outcomes
Frequency of sustained deviation alerts
Time frame: During monitoring, for a maximum of up to 5 postoperative days or until discharge.
Any adverse event
Time frame: 7 days and 30 days after start of monitoring
Any serious adverse event
Time frame: 7 days and 30 days after start of monitoring
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 18 Jun 2023.
- Derived from this study: PubMed 41941065Larsen AT, Sopina L, Molgaard J, Aasvang EK, Meyhoff CS, Kjellberg J, Kristensen SR. Impact of postoperative in-hospital continuous vital sign monitoring on healthcare costs, resource utilization and labor market outcomes. Eur J Health Econ. 2026 Apr 6. doi: 10.1007/s10198-026-01919-2. Online ahead of print.
- Derived from this study: PubMed 40591492Molgaard J, Gronbaek KK, Rasmussen SS, Eiberg JP, Jorgensen LN, Achiam MP, Rohrsted M, Singh UM, Hoang TH, Sogaard M, Meyhoff CS, Aasvang EK. Continuous Vital Sign Monitoring at the Surgical Ward for Improved Outcomes After Major Noncardiac Surgery: A Randomized Clinical Trial. Anesth Analg. 2025 Oct 1;141(4):807-817. doi: 10.1213/ANE.0000000000007606. Epub 2025 Jul 1.
- Related InfoLink provided by the sponsor.
- 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.
Jesper Mølgaard, MD principal investigator
Copenhagen University Hospital, Rigshospitalet
Eske K Aasvang, MD, DMSc study chair
Copenhagen University Hospital, Rigshospitalet
Christian S Meyhoff, MD, PhD study chair
Bispebjerg
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Alarms in people with Complication,Postoperative, run by Copenhagen University Hospital, Rigshospitalet at 2 sites 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 3 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 18 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 2 sites 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 (time frame: During monitoring, for a maximum of up to 5 postoperative days or until discharge.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04640415, which also lists 2 linked publications.
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 18 Jun 2023.