nctId: NCT06289699 id: WARD-CSS international 1251 briefTitle: Alert Frequency, Nurse, and Patient Satisfaction With a wCVSM Software Across Health Care Systems and Cultures overallStatus: RECRUITING date: 2024-02-26 date: 2024-08-01 date: 2024-12-31 date: 2024-03-04 date: 2024-03-04 name: Christian S. Meyhoff class: OTHER name: Rigshospitalet, Denmark briefSummary: 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. conditions: User Experience conditions: Postoperative Complications conditions: Acute Medical Conditions studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 100 type: ESTIMATED measure: Frequency of alerts activated in the app in relation to the alerts that should be activated based on measured data measure: Technical feasibility measure: Alert relay to smartphones measure: Response to alerts measure: Patients experiences from being monitored with wCSVM. measure: Relevance of alarms measure: Frequency of delivered alarms on oxygen saturation (SpO2) pr patient pr day measure: Frequency of delivered alarms on respiration rate (RR) pr patient pr day measure: Frequency of delivered alarms on heart rate (HR) pr patient pr day measure: Frequency of delivered alarms on blod pressure (BP) pr patient pr day measure: Overall score of user satisfaction from use of WARD24/7 app measure: Subscale MAUQ scores measure: Monitoring practices prior to the wCVSM measure: Cumulative duration of SpO2<88% and SpO2 < 85% measure: Cumulative duration of respiratory rate ≤ 5 min-1 and Respiratory rate > 24 min-1 measure: Cumulative duration of Heart rate > 130 min-1 and Heart rate ≤ 30 min-1 measure: Cumulative duration of Systolic blood pressure ≤ 90 mmHg and Systolic blood pressure > 220 mmHg o measure: Cumulative duration of Circulatory failure measure: Cumulative duration of Systolic blood pressure ≤ 90 mmHg AND Heart rate >110 min-1 OR heart rate < 50 bpm AND/OR SpO2 < 92% o measure: Cumulative duration of Hypoventilation: RR < 11 AND SpO2 < 88% sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Cleveland Clinic Foundation, General Anesthesiology status: NOT_YET_RECRUITING city: Cleveland state: Ohio zip: 44195 country: United States name: Daniel Sessler, MD role: CONTACT name: Daniel Sessler, MD role: PRINCIPAL_INVESTIGATOR lat: 41.4995 lon: -81.69541 facility: Universitätsklinikum Hamburg-Eppendorf (UKE), Zentrum für Anästhesiologie und Intensivmedizin, Klinik und Poliklinik für Anästhesiologie status: NOT_YET_RECRUITING city: Hamburg zip: 20246 country: Germany name: Bernd C Saugel, MD, Dr. Med. role: CONTACT name: Bernd C Saugel, MD, Dr. Med. role: PRINCIPAL_INVESTIGATOR lat: 53.57532 lon: 10.01534 facility: University Medical Center Groningen, Department of Anesthesiology status: NOT_YET_RECRUITING city: Groningen zip: 9700 country: Netherlands name: Marjolein Haveman, TP role: CONTACT name: Marjolein Haveman, TP role: PRINCIPAL_INVESTIGATOR lat: 53.21917 lon: 6.56667 facility: St. Olavs Hospital HF, Klinikk for anestesi og intensivmedisin status: RECRUITING city: Trondheim zip: 7006 country: Norway name: Erlend Skraastad, MD, PhD role: CONTACT name: Erlend Skraastad, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 63.43049 lon: 10.39506 facility: Liverpool University Hospitals NHS Foundation Trust status: NOT_YET_RECRUITING city: Liverpool zip: L7 8YE country: United Kingdom name: Ingeborg Welters, Dr. Med. role: CONTACT name: Ingeborg Welters, Dr. Med. role: PRINCIPAL_INVESTIGATOR lat: 53.41058 lon: -2.97794 hasResults: False