Optimized Novel Wireless Assessment of Respiratory and Circulatory Dirstress - Alarm Validation (ONWARD - AV)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Postoperative Care; Deterioration, Clinical
• Intervention / Treatment: Device: Continuous vital sign monitoring

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 Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eske K Aasvang, DMSci; Phone Number: +4526232076; Email: Eske.Kvanner.Aasvang.01@regionh.dk
• Study Contact Backup: Name: Aslak B Johansen, M.D.; Phone Number: +4522952551; Email: aslak.broby.johansen@regionh.dk

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • Rigshospitalet
  • Copenhagen, Denmark, 2400
    • Bispebjerg Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Adult, hospitalized patients who are monitored for vital signs in the general wards	Device: Continuous 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Alert rate	Total alert rate, including false alert rate, of the WARD-CSS.	Start of monitoring after enrollment with informed consent. An expected minimum of 24 hours of monitoring up to 7 days after start of monitoring.
Postoperative complications	Postoperative complications, defined by internationally agreed criteria	30 days
Heart rate (measured in beats per minute (BPM))	Collected continuously	7 days
SpO2 (blood oxygen saturation, measured in percentage)	Collected continuously	7 days
Blood pressure (measured in mmHg)	Collected continuously	7 days
Respiration Rate (measured in BrPM)	Collected continuously	7 days
Pulse (measured in BPM)	Peripheral pulse - Collected continuously	7 days
Temperature (measured in degrees Celcius)	Collected continuously	7 days

Collaborators and Investigators

• Sponsor: Eske Kvanner Aasvang
• Collaborators: Rigshospitalet, Denmark; University Hospital Bispebjerg and Frederiksberg

Study record dates

Study Major Dates

• Study Start (Estimated): May 28, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): March 31, 2028

Study Registration Dates

• First Submitted: June 1, 2026
• First Submitted That Met QC Criteria: June 10, 2026
• First Posted (Actual): June 16, 2026

Study Record Updates

• Last Update Posted (Actual): June 16, 2026
• Last Update Submitted That Met QC Criteria: June 10, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: continuous monitoring; Vital sign; automated alerts
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Disease Progression; Pathological Conditions, Signs and Symptoms; Clinical Deterioration
• Other Study ID Numbers: 2502107 (MREC); 2025071987 (Other Identifier: DMA)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Data access can be discussed upon request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No