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NCT Number: NCT07649642

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bispebjerg Hospital, Copenhagen, Denmark

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About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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.

Treatment and study plan

Continuous vital sign monitoring

Device

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.

Primary outcomes

  1. 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:

    • Not relevant 2 Slightly relevant 3 Moderately relevant 4 Relevant 5 Highly Relevant

Secondary outcomes

  1. 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.

    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

Other outcomes

  1. Alert rate

    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.

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

  2. Postoperative complications

    Time frame: 30 days

    Postoperative complications, defined by internationally agreed criteria

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

    Time frame: 7 days

    Collected continuously

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

    Time frame: 7 days

    Collected continuously

  5. Blood pressure (measured in mmHg)

    Time frame: 7 days

    Collected continuously

  6. Respiration Rate (measured in BrPM)

    Time frame: 7 days

    Collected continuously

  7. Pulse (measured in BPM)

    Time frame: 7 days

    Peripheral pulse - Collected continuously

  8. Temperature (measured in degrees Celcius)

    Time frame: 7 days

    Collected continuously

Study contacts

Contact information is provided by the study sponsor or research team.

Aslak B Johansen, M.D.

CONTACT

[email protected]

+4522952551

Eske K Aasvang, DMSci

CONTACT

[email protected]

+4526232076

Sponsors and collaborators

Lead sponsor

Eske Kvanner Aasvang

Other

Collaborators

  • Rigshospitalet, Denmark
  • University Hospital Bispebjerg and Frederiksberg

Registry information

Official study title

Validation of the Accuracy and Relevance of Continuous Vital Sign Monitoring Using an AI-algorithm in Hospitalized Patients

Acronym: ONWARD - AV

Important dates

Study start
2026
Primary completion
2026
Study completion
2028
First posted
Jun 16, 2026
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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