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