Continuous wireless monitoring of vital signs at home and in hospitals
WARD Prospective Study - Continuous Wireless Monitoring of Vital Signs and Automated Alerts in Participants at Home and During Hospitalization
This study is testing a new wireless system that continuously tracks vital signs to see if it helps high-risk patients, like those recovering from major surgeries or dealing with chronic lung issues, get better care at home and in hospitals.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 3095 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital Bispebjerg and Frederiksberg Academic / other |
| Locations | 1 site (Copenhagen, Copenhagen) |
| Trial ID | NCT05378139 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of continuous wireless monitoring of vital signs using the WARD-Clinical Support System (WARD-CSS) in high-risk patients. It combines real-time data collection from multiple physiological modalities with machine learning algorithms to predict and alert clinical staff about potential deterioration. The study will assess the quality of data and user satisfaction over time, comparing initial and later phases of monitoring. The focus is on patients with acute conditions, both at home and during hospitalization, particularly those undergoing major surgeries or with chronic pulmonary diseases.
Who should consider this trial
Good fit: Ideal candidates include adults with acute conditions at risk of clinical deterioration, either at home or in the hospital, particularly those undergoing major surgeries.
Not a fit: Patients who are unable to cooperate with study procedures or have specific medical devices like pacemakers or ICDs may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance patient safety by enabling earlier detection of critical health changes.
How similar studies have performed: Previous pilot studies have shown promising results in similar monitoring approaches, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Copenhagen, Copenhagen
- Rigshospitalet — Copenhagen, Copenhagen, Denmark (Recruiting)
Study contacts
- Study coordinator: Eske Aasvang, MD
- Email: eske.kvanner.aasvang@regionh.dk
- Phone: 26232076
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.