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

NCT06289699 | Recruiting DMC

• 1 other identifier: WARD-CSS international 1251
• Study Type: observational
• Target: 100
• Locations: 5 countries
• Sites: 5

Brief Summary

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; Postoperative Complications; Acute Medical Conditions

Keywords

continuous wireless vital sign monitoring; vital sign deviation; healthcare system and culture; User Experience; Postoperative Complications; Acute Medical Conditions

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Technical feasibility

  during monitoring period, on average 3 months

• Alert relay to smartphones

  during monitoring period, on average 3 months

• Response to alerts

  during monitoring period, on average 3 months

• Patients experiences from being monitored with wCSVM.

  during monitoring period, on average 3 months

• Relevance of alarms

  during monitoring period, on average 3 months

Other Outcomes (7)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Christian S. Meyhoff: lead
• Rigshospitalet, Denmark: collaborator

Study Sites (5)

The Cleveland Clinic Foundation, General Anesthesiology

Cleveland, Ohio, 44195, United States

NOT YET RECRUITING

Universitätsklinikum Hamburg-Eppendorf (UKE), Zentrum für Anästhesiologie und Intensivmedizin, Klinik und Poliklinik für Anästhesiologie

Hamburg, 20246, Germany

COMPLETED

University Medical Center Groningen, Department of Anesthesiology

Groningen, 9700, Netherlands

RECRUITING

St. Olavs Hospital HF, Klinikk for anestesi og intensivmedisin

Trondheim, 7006, Norway

COMPLETED

Liverpool University Hospitals NHS Foundation Trust

Liverpool, L7 8YE, United Kingdom

NOT YET RECRUITING

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katja K Head of Clinical, MD

CONTACT

004528781188; katja.groenbaek@ward247.com

Eske Kvanner Aasvang, MD

CONTACT

Eske.Kvanner.Aasvang.01@regionh.dk

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, PhD

Study Record Dates

• First Submitted: January 22, 2024
• First Posted: March 4, 2024
• Study Start: February 26, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1); DE (1); US (1); NO (1); NL (1)