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Not yet recruitingNCT07649642ONWARD - AVUpdated Jun 16, 2026

Optimized Novel Wireless Assessment of Respiratory and Circulatory Dirstress - Alarm Validation

An interventional study of Continuous vital sign monitoring in Postoperative Care and Deterioration, Clinical, sponsored by Eske Kvanner Aasvang. Not yet recruiting at 2 sites in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-16.

Sponsored by Eske Kvanner Aasvang · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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 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)
02

Conditions studied

  • Postoperative Care
  • Deterioration, Clinical

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Keywords

  • Vital sign
  • continuous monitoring
  • automated alerts
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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.

Exclusion criteria

Exclusion criteria:

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.
04

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Adult, hospitalized patients who are monitored for vital signs in the general wards

    Device: Continuous vital sign monitoring

Interventions

  • DeviceContinuous vital sign monitoring

    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.

05

What researchers measure

Primary outcomes

  1. Relevance of alerts

    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

    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.

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: 1. Strongly Disagree 2. Disagree 3- Undecided 4 Agree 5 Strongly Agree

    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.

Other outcomes

  1. Alert rate

    Total alert rate, including false alert rate, of the WARD-CSS.

    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.

  2. Postoperative complications

    Postoperative complications, defined by internationally agreed criteria

    Time frame: 30 days

  3. Heart rate (measured in beats per minute (BPM))

    Collected continuously

    Time frame: 7 days

  4. SpO2 (blood oxygen saturation, measured in percentage)

    Collected continuously

    Time frame: 7 days

  5. Blood pressure (measured in mmHg)

    Collected continuously

    Time frame: 7 days

  6. Respiration Rate (measured in BrPM)

    Collected continuously

    Time frame: 7 days

  7. Pulse (measured in BPM)

    Peripheral pulse - Collected continuously

    Time frame: 7 days

  8. Temperature (measured in degrees Celcius)

    Collected continuously

    Time frame: 7 days

06

Study locations

2 sites
  • Rigshospitalet
    Copenhagen, 2100, Denmark
  • Bispebjerg Hospital
    Copenhagen, 2400, Denmark
07

References and documents

Individual participant data

Plan to share: Undecided — Data access can be discussed upon request

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07649642
Lead sponsor
Eske Kvanner Aasvang
Collaborators
Rigshospitalet, Denmark, University Hospital Bispebjerg and Frederiksberg
Responsible party
Eske Kvanner Aasvang (Professor, M.D., DMSCi, Rigshospitalet, Denmark) — Sponsor-investigator
First posted
Jun 16, 2026
Start date
May 28, 2026 (estimated)
Primary completion
Sep 30, 2026 (estimated)
Completion
Mar 31, 2028 (estimated)
Last update
Jun 16, 2026

Study contacts

Aslak B Johansen, M.D.
Contact
aslak.broby.johansen@regionh.dk
+4522952551
Eske K Aasvang, DMSci
Contact
Eske.Kvanner.Aasvang.01@regionh.dk
+4526232076

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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