Optimized Novel Wireless Assessment of Respiratory and Circulatory Dirstress - Alarm Validation
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorEske Kvanner Aasvang
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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 design
Design model
Single group
Treatments tested in this trial
Continuous vital sign monitoring
DeviceThe 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.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Adult, hospitalized patients who are monitored for vital signs in the general wardsExperimental treatment 1 intervention
Trial outcomes
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 days3
Heart rate (measured in beats per minute (BPM))
Collected continuously
Time frame
7 days4
SpO2 (blood oxygen saturation, measured in percentage)
Collected continuously
Time frame
7 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Eske Kvanner Aasvang
Lead sponsor
Rigshospitalet, Denmark
Sponsor institution
Rigshospitalet, Denmark
Collaborator
University Hospital Bispebjerg and Frederiksberg
Collaborator
Source ClinicalTrials.gov
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