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

Alert Frequency, Nurse, and Patient Satisfaction With a Continuous Wireless Vital Sign Monitoring Software Across Health Care Systems and Cultures

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.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Complications; Acute Medical Conditions; User Experience

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Katja K Head of Clinical, MD; Phone Number: 004528781188 004528781188; Email: katja.groenbaek@ward247.com
• Study Contact Backup: Name: Eske Kvanner Aasvang, MD; Email: Eske.Kvanner.Aasvang.01@regionh.dk

Study Locations

• Germany
  • Hamburg, Germany, 20246
    • Completed
    • Universitätsklinikum Hamburg-Eppendorf (UKE), Zentrum für Anästhesiologie und Intensivmedizin, Klinik und Poliklinik für Anästhesiologie
• Netherlands
  • Groningen, Netherlands, 9700
    • Recruiting
    • University Medical Center Groningen, Department of Anesthesiology
    • Contact: Marjolein Haveman, TP
    • Principal Investigator: Marjolein Haveman, TP
• Norway
  • Trondheim, Norway, 7006
    • Completed
    • St. Olavs Hospital HF, Klinikk for anestesi og intensivmedisin
• United Kingdom
  • Liverpool, United Kingdom, L7 8YE
    • Not yet recruiting
    • Liverpool University Hospitals NHS Foundation Trust
    • Contact: Ingeborg Welters, Dr. Med.
    • Principal Investigator: Ingeborg Welters, Dr. Med.
• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Not yet recruiting
      • The Cleveland Clinic Foundation, General Anesthesiology
      • Contact: Daniel Sessler, MD
      • Principal Investigator: Daniel Sessler, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

20 Patients in the general ward (surgical or medical) will be monitored with wCVSM and answer a questionnaire afterwards. 20 nurses will answer a questionnaire after having had the responsibility for a monitored patient for a full shift (including a shift where monitoring is initiated or a shift where the patient is discharged). Therefore, multiple nurses can be interviewed per patient. Patients will in addition have vital signs monitored as per standard practice. Participants will be recruited from wards at the study sites.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Frequency of alerts activated in the app in relation to the alerts that should be activated based on measured data	during monitoring period, on average 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical feasibility	will be assessed as data capture of vital signs as percentage of data from each of the vital sign sensors of the total monitoring period.	during monitoring period, on average 3 months
Alert relay to smartphones	will be assessed by comparing % of alerts received compared to alerts generated by the WARD24/7 App.	during monitoring period, on average 3 months
Response to alerts	will be assessed using the response buttons as % of nurses pressing attend, snooze, or refer to colleague on the WARD24/7 App.	during monitoring period, on average 3 months
Patients experiences from being monitored with wCSVM.	will be assessed by a questionnaire named "Patient experience with wireless vital sign monitorering" consisting of 8 items. Each item can be answered with: strongly agree, agree, neither agree nor disagree, disagree, and strongly disagree.	during monitoring period, on average 3 months
Relevance of alarms	by using feedback from the nurses given in the app, % of relevant alerts	during monitoring period, on average 3 months
Frequency of delivered alarms on oxygen saturation (SpO2) pr patient pr day		during monitoring period, on average 3 months
Frequency of delivered alarms on respiration rate (RR) pr patient pr day		during monitoring period, on average 3 months
Frequency of delivered alarms on heart rate (HR) pr patient pr day		during monitoring period, on average 3 months
Frequency of delivered alarms on blod pressure (BP) pr patient pr day		during monitoring period, on average 3 months
Overall score of user satisfaction from use of WARD24/7 app	assessed by the mHealth App Usability Questionnaire (MAUQ) consisting of 18 items. In this questionnaire, 1 - strongly disagree, 2 - disagree, 3 - somewhat disagree, 4 - neither agree nor disagree, 5 - somewhat agree, 6 - agree, 7 - strongly agree.To determine the usability of an app, calculate the total and determine the average of the responses to all statements. The higher the overall average, the higher the usability of the app.	during monitoring period, on average 3 months
Subscale MAUQ scores	assessed by the mHealth App Usability Questionnaire (MAUQ) consisting of 18 items. In this questionnaire, 1 - strongly disagree, 2 - disagree, 3 - somewhat disagree, 4 - neither agree nor disagree, 5 - somewhat agree, 6 - agree, 7 - strongly agree.To determine the usability of an app, calculate the total and determine the average of the responses to all statements. The higher the overall average, the higher the usability of the app. Ease of use and satisfaction (5 items, MAUQ_E), system information arrangement (7 items, MAUQ_I), and usefulness (6 items, MAUQ_U).	during monitoring period, on average 3 months
Monitoring practices prior to the wCVSM	assessed by a semi structured interview guide including information on type of monitoring (manual/intermittent, type of vital signs collected, frequency of measurements, escalation protocols etc.).	Baseline, on average 3 months

Other Outcome Measures

Outcome Measure	Time Frame
Cumulative duration of SpO2<88% and SpO2 < 85%	during monitoring period, on average 3 months
Cumulative duration of respiratory rate ≤ 5 min-1 and Respiratory rate > 24 min-1	during monitoring period, on average 3 months
Cumulative duration of Heart rate > 130 min-1 and Heart rate ≤ 30 min-1	during monitoring period, on average 3 months
Cumulative duration of Systolic blood pressure ≤ 90 mmHg and Systolic blood pressure > 220 mmHg o	during monitoring period, on average 3 months
Cumulative duration of Circulatory failure	during monitoring period, on average 3 months
Cumulative duration of Systolic blood pressure ≤ 90 mmHg AND Heart rate >110 min-1 OR heart rate < 50 bpm AND/OR SpO2 < 92% o	during monitoring period, on average 3 months
Cumulative duration of Hypoventilation: RR < 11 AND SpO2 < 88%	during monitoring period, on average 3 months

Collaborators and Investigators

• Sponsor: Christian S. Meyhoff
• Collaborators: Rigshospitalet, Denmark
• Investigators: Principal Investigator: Christian S Meyhoff, MD, PhD, Copenhagen University Hospital - Bispebjerg and Frederiksberg, Copenhagen, Denmark; Principal Investigator: Eske K Aasvang, MD, DMSci, Rigshospitalet, Copenhagen University, Copenhagen, Denmark

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: January 22, 2024
• First Submitted That Met QC Criteria: March 1, 2024
• First Posted (Actual): March 4, 2024

Study Record Updates

• Last Update Posted (Actual): August 12, 2025
• Last Update Submitted That Met QC Criteria: August 11, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Postoperative Complications; User Experience; continuous wireless vital sign monitoring; vital sign deviation; healthcare system and culture; Acute Medical Conditions
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications
• Other Study ID Numbers: WARD-CSS international 1251

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No