Alert frequency and nurse/patient satisfaction with a wireless continuous vital-sign monitoring app
Alert Frequency, Nurse, and Patient Satisfaction With a Continuous Wireless Vital Sign Monitoring Software Across Health Care Systems and Cultures
This pilot will test whether a wearable continuous vital-sign monitoring system and its app work well and are acceptable to adult patients and nurses on general wards after surgery or acute medical admission.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital Bispebjerg and Frederiksberg Academic / other |
| Locations | 5 sites (Cleveland, Ohio and 4 other locations) |
| Trial ID | NCT06289699 on ClinicalTrials.gov |
What this trial studies
This is a prospective international multi-centre pilot that enrolls about 20 patients and 20 nurses per centre to use a wireless continuous vital-sign monitoring system alongside standard monitoring. Patients are monitored for four days postoperatively or for four days after acute admission and until discharge, and nurses take responsibility for monitored patients for a full shift. The study compares alerts generated in the mobile/web app with alerts that should have been triggered based on measured data, uses questionnaires to measure nurse and patient satisfaction, and conducts semi-structured interviews to map differences in monitoring practices across health-care systems and cultures. Devices used are validated FDA or CE-approved systems (e.g., Sotera Visimobile or Isansys Lifeguard) paired with the CE-approved WARD app.
Who should consider this trial
Good fit: Adults (≥18) expected to stay ≥2 days who are admitted for surgery lasting >2 hours or admitted for an acute medical condition with specified abnormal vital signs within 24 hours of admission are ideal candidates.
Not a fit: Patients with pacemakers or ICDs, those allergic to plaster or silicone, those unable to give informed consent, or those expected not to cooperate are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, this could reduce missed signs of deterioration and make monitoring less intrusive and easier to use for patients and nurses.
How similar studies have performed: Other studies of wireless continuous vital-sign monitoring have shown feasibility and improved detection in some settings, but findings on alert burden and clinical outcome benefits have been mixed.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults (≥18 years) * Expected stay in the hospital ≥2 days * Admitted for surgery with expected duration of surgery \>2 hours or admitted for acute medical condition with at least one of the following vital sign deviations within 24 hours of acute admission, recorded by the staff * RR \> 21 breaths pr minute * RR \< 11 breaths pr minute * Pulse (P) \> 91 beats pr minute * Pulse (P) \< 50 beats pr minute * SpO2 \< 94 % without oxygen supplementation * Systolic BP \< 110 mmHg * Systolic BP \> 220 mmHg Exclusion Criteria: * Participant expected not to cooperate with study procedures. * Allergy to plaster or silicone. * Pacemaker or Implantable Cardioverter Defibrillator (ICD) device. * Inability to give informed consent.
Where this trial is running
Cleveland, Ohio and 4 other locations
- The Cleveland Clinic Foundation, General Anesthesiology — Cleveland, Ohio, United States (Not_yet_recruiting)
- Universitätsklinikum Hamburg-Eppendorf (UKE), Zentrum für Anästhesiologie und Intensivmedizin, Klinik und Poliklinik für Anästhesiologie — Hamburg, Germany (Completed)
- University Medical Center Groningen, Department of Anesthesiology — Groningen, Netherlands (Recruiting)
- St. Olavs Hospital HF, Klinikk for anestesi og intensivmedisin — Trondheim, Norway (Completed)
- Liverpool University Hospitals NHS Foundation Trust — Liverpool, United Kingdom (Not_yet_recruiting)
Study contacts
- Principal investigator: Christian S Meyhoff, MD, PhD — Copenhagen University Hospital - Bispebjerg and Frederiksberg, Copenhagen, Denmark
- Study coordinator: Katja K Head of Clinical, MD
- Email: katja.groenbaek@ward247.com
- Phone: 004528781188
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.