Clinical trial NCT05378139: Continuous Wireless Monitoring of Vital Signs and Automated Alerts in Participants at Home and During Hospitalization
Official title: WARD Prospective Study - Continuous Wireless Monitoring of Vital Signs and Automated Alerts in Participants at Home and During Hospitalization
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Surgical Complication
Pulmonary Disease
Hematologic Diseases
Oncology
Cardiac Disease
Infections
Lead sponsor: University Hospital Bispebjerg and Frederiksberg
Sponsor class: OTHER
Collaborators: name: Rigshospitalet, Denmark
First posted: 2022-05-18
Enrollment: 3095
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients assessed by the clinical staff as having an acute condition with risk for clinical deterioration and being either at home (with no apparent need for hospitalization), and/or in hospital

OR

Patients at either at home before, in-hospital and/or after hospitalization for elective major surgery, defined as surgery lasting more than one hour under general- or regional anaesthesia

Brief summary: The primary aim of this study is to test and assess the implementation and effectiveness of continuous wireless vital signs monitoring with real-time alerts on:

The frequency of patients monitored with adequate data quality as adequate clinical user satisfaction in the initial versus the last part of the trial (primary outcome).

Detailed description: Over the last years, the applicants and research team partners have developed the WARD (Wireless Assessment of Respiratory and circulatory Distress) project, using continuous wireless monitoring of vital signs and artificial intelligence algorithms for data interpretation in high-risk patient admitted to medical and surgical wards. The WARD project combines continuous measurements of 10 different physiological modalities with machine learning to develop the WARD-Clinical Support System (WARD-CSS), based on multiple intelligent algorithms, that automatically monitors, interprets, predicts and alert clinical staff. Through a mobile device with a purpose-built Graphic User Interface (GUI), the WARD-CSS stimulates human-machine interaction to improve the monitoring of high-risk hospitalized patients.

The WARD project has hitherto proven an unmet need for continuous monitoring and the potential for automatic detection and prediction of physiological deterioration events. Specifically, observational pilot studies of both patients with acute exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD) and postoperative abdominal cancer surgery patients have shown that episodes of desaturation, tachycardia, tachypnea, and bradypnea are much more frequently detected using continuous vital signs monitoring than with existing Early Warning Score (EWS) systems.

Ongoing investigations will determine the efficacy in two very selected populations of high-risk surgical patients and acutely ill medical patients with severe disease. This study will investigate the WARD-systems' implementation, and effectiveness of use and impact in a cohort of patientparticipants admitted

Eligibility criteria: Inclusion Criteria:

* Adult participants (≥18 years)
* Patients assessed by the clinical staff as having an acute condition with risk for clinical deterioration and being either at home (with no apparent need for hospitalization), and/or in hospital OR
* Patients at either at home before, in-hospital and/or after hospitalization for elective major surgery, defined as surgery lasting more than one hour under general- or regional anaesthesia

Exclusion Criteria:

* The participant expected not to cooperate with study procedures.
* Allergy to plaster or silicone.
* Having pacemaker or Implantable Cardioverter Defibrillator (ICD) device.
* Inability to give informed consent.

Primary outcomes:
measure: Data quality
timeFrame: 30 days
measure: user satisfaction
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
References: