Alert Frequency, Nurse, and Patient Satisfaction With a wCVSM Software Across Health Care Systems and Cultures

Christian S. Meyhoff

Status: Enrolling

Conditions: Postoperative Complications; Acute Medical Conditions; User Experience

Study type: Observational

Funder types: Other

Identifiers

NCT06289699

WARD-CSS international 1251

Details and patient eligibility

About

The goal of this prospective, international multi-centre pilot study is to assess the functionality and user experience of a new vital sign monitoring system in 20 patients and 20 nurses in the general ward at each centre. The patients will be monitored with a wireless, continuous vital sign monitoring systems and answer a questionnaire afterwards. They will in addition have vital signs monitored as per standard practice. The nurses will answer a questionnaire after having had the responsibility for a monitored patient for a full shift. The main aims are: To determine the frequency of alerts activated in the app in relation to the alerts that should be activated based on measured data, to explore current practices of in-hospital monitoring by semi-structured interviews to map differences across systems and to test nurse and patient satisfaction.

Full description

The participants will be monitored for 4 days postoperatively or for 4 days after acute admission and until discharge.

Monitoring devices used in this study will be validated FDA or/and CE approved devices used within their original purpose. Centers can choose to use Sotera Visimobile or Isansys Lifeguard with accompanying sensors. These devices will be used together with the CE approved WARD web and mobile application.

Study sites include: St. Olav Hospital Trondheim, Royal Liverpool University Hospital, University Medical Centre Hamburg-Eppendorf,University Medical Centre Groningen, The Netherlands and the Cleveland Clinic.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.