Alert frequency and nurse/patient satisfaction with a wireless continuous vital-sign monitoring app

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• University Medical Center Groningen, Department of Anesthesiology
  Groningen, Netherlands Recruiting
• 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
• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.