Postoperative CareONWARD - AVNCT07649642
Optimized Novel Wireless Assessment of Respiratory and Circulatory Dirstress - Alarm Validation
A study testing Continuous vital sign monitoring in people with Postoperative Care and Deterioration, Clinical, run by Eske Kvanner Aasvang at 2 sites in Denmark.
Trial summary
The ONWARD study evaluates user experiences from continuous vital sign monitoring alarms sent to the clinical staff in case of deviating vital signs at the general hospital ward. User experiences are evaluated though a 5-point likert questionnaire. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Care, Deterioration, Clinical
- What is being tested?
- Continuous vital sign monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesDenmark
- Study dates
- 28 May 2026to 31 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Patients can be included if they meet all the following criteria:
- Age ≥ 18 years
- Patients assessed by the clinical staff as having an acute condition with risk for clinical deterioration.
- Expected admission for more than 24 hours to a general ward.
Who cannot join
- Patients are excluded if they meet any of the following criteria:
- Having implanted electronic devices (such as pacemaker or Implantable Cardioverter Defibrillator (ICD) device).
- Known pregnancy or breastfeeding
- Inability to give informed consent.
- The participant expected not to cooperate with study procedures.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark2 sites
Rigshospitalet
Copenhagen, 2100
Bispebjerg Hospital
Copenhagen, 2400
About this study
Official title: Validation of the Accuracy and Relevance of Continuous Vital Sign Monitoring Using an AI-algorithm in Hospitalized Patients
The ONWARD study evaluates user experiences from continuous vital sign monitoring alarms sent to the clinical staff in case of deviating vital signs at the general hospital ward. User experiences are evaluated though a 5-point likert questionnaire.
Read the detailed description
The ONWARD study evaluates user experiences from continuous vital sign monitoring alarms sent to the clinical staff in case of deviating vital signs at the general hospital ward. User experiences are evaluated though a 5-point likert questionnaire.
The study will focus on adult, hospitalized patients who are monitored at the general hospital ward with continuous, real-time vital sign monitoring combined with the WARD-CSS (WARD clinical support system) that relays alerts to the clinical staff in case of significant deviations. The evaluation focus on the user perceived relevance and usefulness of the alerts generated by the system which includes a proprietary novel alerts logic. Specifically, investigators aim to assess how users evaluate the clinical relevance of triggered change-based alerts and the helpfulness of the accompanying alert descriptions.
During monitoring, the app will be used according to the intended use and additionally two questions will be prompted if alerts are sent.
Patients monitored will have an expected length of stay at the hospital, which supports at least one day of continuous monitoring. Readings from the WARD-CSS is not blinded for treating staff to get feedback on the use of the application. This study will include up to 100 patients.
An alerting feedback questionnaire will be constructed as simple feedback buttons/sliders, prompted after an alert is 'accepted' in the app. The feedback buttons will only be prompted for a representative proportion of the alerts. This will be done at random based on the alert frequencies determined in the retrospective analysis. This way, a close to equal amount of feedback responses will be prompted and obtained for different alert types with different occurrences. The feedback will be linked to the alert in the app, such that feedback can be submitted at any point in time, thus not disturbing the nurse while medical intervention is provided.
The feedback will be constructed with the following two interactions for the clinical staff.
- Alert relevance in relation to deterioration of the patient (5-point Likert scale).
- Relevance of the description following alerts in relation to the helpfulness in the patient assessment/care (5-point Likert scale)
- Conditions
- Postoperative Care, Deterioration, Clinical
- Being tested
- Continuous vital sign monitoring
- Keywords
- Vital sign, continuous monitoring, automated alerts
- Medical subject headings
- Clinical Deterioration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous vital sign monitoringDevice
The intervention involves continuous, real-time vital sign monitoring using sensors to measure vital signs combined with WARD-CSS and novel algorithms designed to detect clinically relevant deviations in the vital signs.
| Study group | Role | What they receive |
|---|---|---|
| Adult, hospitalized patients who are monitored for vital signs in the general wards | Experimental | Not described Receives: Device: Continuous vital sign monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relevance of alerts
The staff evaluated relevance of alerts triggered during continuous vital signs monitoring
Evaluated by 5-point Likert scale:
- Not relevant 2 Slightly relevant 3 Moderately relevant 4 Relevant 5 Highly Relevant
Measured: Start of monitoring after enrollment with informed consent. An expected minimum of 24 hours of monitoring up to 7 days after start of monitoring.
Secondary outcomes (1)
Relevance of the description
Relevance of the description following alerts in relation to the helpfulness in the patient assessment/care
Evaluated by 5-point Likert scale:
- Strongly Disagree
- Disagree 3- Undecided
4 Agree 5 Strongly Agree
Measured: Start of monitoring after enrollment with informed consent. An expected minimum of 24 hours of monitoring up to 7 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 posted16 Jun 2026
- Study start28 May 2026 (estimated)
- Primary completion30 Sep 2026 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative CareStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eske Kvanner Aasvang
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet, University Hospital Bispebjerg and Frederiksberg
- Responsible party
- Sponsor-investigator, Eske Kvanner Aasvang, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07649642
- Sponsor's protocol ID
- 2502107 (MREC)
- Other IDs
- 2025071987
- Acronym
- ONWARD - AV
- Status last verified
- Jun 2026
- First submitted
- 1 Jun 2026
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data access can be discussed upon request
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the Accuracy and Relevance of Continuous Vital Sign Monitoring Using an AI-algorithm in Hospitalized Patients
- ClinicalTrials.gov ID
- NCT07649642
- Acronym / sponsor ID
- ONWARD - AV / 2502107 (MREC)
- Conditions
- Postoperative Care, Deterioration, Clinical
- Keywords
- Vital sign, continuous monitoring, automated alerts
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Eske Kvanner AasvangUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet, University Hospital Bispebjerg and Frederiksberg
- Study start
- 28 May 2026 (estimated)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 16 Jun 2026 (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 ONWARD study evaluates user experiences from continuous vital sign monitoring alarms sent to the clinical staff in case of deviating vital signs at the general hospital ward. User experiences are evaluated though a 5-point likert questionnaire.
Detailed description
The ONWARD study evaluates user experiences from continuous vital sign monitoring alarms sent to the clinical staff in case of deviating vital signs at the general hospital ward. User experiences are evaluated though a 5-point likert questionnaire.
The study will focus on adult, hospitalized patients who are monitored at the general hospital ward with continuous, real-time vital sign monitoring combined with the WARD-CSS (WARD clinical support system) that relays alerts to the clinical staff in case of significant deviations. The evaluation focus on the user perceived relevance and usefulness of the alerts generated by the system which includes a proprietary novel alerts logic. Specifically, investigators aim to assess how users evaluate the clinical relevance of triggered change-based alerts and the helpfulness of the accompanying alert descriptions.
During monitoring, the app will be used according to the intended use and additionally two questions will be prompted if alerts are sent.
Patients monitored will have an expected length of stay at the hospital, which supports at least one day of continuous monitoring. Readings from the WARD-CSS is not blinded for treating staff to get feedback on the use of the application. This study will include up to 100 patients.
An alerting feedback questionnaire will be constructed as simple feedback buttons/sliders, prompted after an alert is 'accepted' in the app. The feedback buttons will only be prompted for a representative proportion of the alerts. This will be done at random based on the alert frequencies determined in the retrospective analysis. This way, a close to equal amount of feedback responses will be prompted and obtained for different alert types with different occurrences. The feedback will be linked to the alert in the app, such that feedback can be submitted at any point in time, thus not disturbing the nurse while medical intervention is provided.
The feedback will be constructed with the following two interactions for the clinical staff.
- Alert relevance in relation to deterioration of the patient (5-point Likert scale).
- Relevance of the description following alerts in relation to the helpfulness in the patient assessment/care (5-point Likert scale)
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult, hospitalized patients who are monitored for vital signs in the general wards | Experimental | Device: Continuous vital sign monitoring |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Patients assessed by the clinical staff as having an acute condition with risk for clinical deterioration.
- Expected admission for more than 24 hours to a general ward.
Key exclusion criteria (5 listed)
- Having implanted electronic devices (such as pacemaker or Implantable Cardioverter Defibrillator (ICD) device).
- Known pregnancy or breastfeeding
- Inability to give informed consent.
- The participant expected not to cooperate with study procedures.
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 |
|---|---|---|
| Continuous vital sign monitoringThe intervention involves continuous, real-time vital sign monitoring using sensors to measure vital signs combined with WARD-CSS and novel algorithms designed to detect clinically relevant deviations in the vital signs. | Device | Adult, hospitalized patients who are monitored for vital signs in the general wards |
Primary outcome
Relevance of alerts
Time frame: Start of monitoring after enrollment with informed consent. An expected minimum of 24 hours of monitoring up to 7 days after start of monitoring.
The staff evaluated relevance of alerts triggered during continuous vital signs monitoring Evaluated by 5-point Likert scale: 1. Not relevant 2 Slightly relevant 3 Moderately relevant 4 Relevant 5 Highly Relevant
1 secondary outcome
Relevance of the description
Time frame: Start of monitoring after enrollment with informed consent. An expected minimum of 24 hours of monitoring up to 7 days after start of monitoring.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Individual participant dataSharing planned: Undecided. Data access can be discussed upon request
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous vital sign monitoring in people with Postoperative Care and Deterioration, Clinical, run by Eske Kvanner Aasvang 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 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: opening soon, as of the sponsor's last update on 16 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aslak B Johansen, M.D. (+4522952551, aslak.broby.johansen@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relevance of alerts (time frame: Start of monitoring after enrollment with informed consent. An expected minimum of 24 hours of monitoring up to 7 days after start of monitoring.). 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 16 Jun 2026.