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

NCT07649642 | Not Yet Recruiting DMC

• 2 other identifiers: 2502107 (MREC)2025071987
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Postoperative Care; Deterioration, Clinical

Keywords

Vital sign; continuous monitoring; automated alerts

Outcome Measures

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

  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

  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 (8)

• Alert rate

  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

  30 days

• Heart rate (measured in beats per minute (BPM))

  7 days

Study Arms (1)

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

EXPERIMENTAL

Device: Continuous vital sign monitoring

Interventions

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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eske Kvanner Aasvang: lead
• Rigshospitalet, Denmark: collaborator
• University Hospital Bispebjerg and Frederiksberg: collaborator

Study Sites (2)

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Bispebjerg Hospital

Copenhagen, 2400, Denmark

Location

MeSH Terms

Conditions

Clinical Deterioration

Condition Hierarchy (Ancestors)

Disease Progression; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Aslak B Johansen, M.D.

CONTACT

+4522952551; aslak.broby.johansen@regionh.dk

Eske K Aasvang, DMSci

CONTACT

+4526232076; Eske.Kvanner.Aasvang.01@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, M.D., DMSCi

Study Record Dates

• First Submitted: June 1, 2026
• First Posted: June 16, 2026
• Study Start: May 28, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): March 31, 2028
• Last Updated: June 16, 2026

Record last verified: 2026-06

Locations

DK (2)