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

NCT ID: NCT06289699

Last Updated: 2025-08-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-02-26

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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User Experience Postoperative Complications Acute Medical Conditions

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rigshospitalet, Denmark

OTHER

Sponsor Role collaborator

Christian S. Meyhoff

OTHER

Sponsor Role lead

Responsible Party

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Christian S. Meyhoff

Professor, PhD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Christian S Meyhoff, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Copenhagen University Hospital - Bispebjerg and Frederiksberg, Copenhagen, Denmark

Eske K Aasvang, MD, DMSci

Role: PRINCIPAL_INVESTIGATOR

Rigshospitalet, Copenhagen University, Copenhagen, Denmark

Locations

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The Cleveland Clinic Foundation, General Anesthesiology

Cleveland, Ohio, United States

Site Status NOT_YET_RECRUITING

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

Hamburg, , Germany

Site Status COMPLETED

University Medical Center Groningen, Department of Anesthesiology

Groningen, , Netherlands

Site Status RECRUITING

St. Olavs Hospital HF, Klinikk for anestesi og intensivmedisin

Trondheim, , Norway

Site Status COMPLETED

Liverpool University Hospitals NHS Foundation Trust

Liverpool, , United Kingdom

Site Status NOT_YET_RECRUITING

Countries

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United States Germany Netherlands Norway United Kingdom

Central Contacts

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Katja K Head of Clinical, MD

Role: CONTACT

[email protected]
004528781188 ext. 004528781188

Eske Kvanner Aasvang, MD

Role: CONTACT

[email protected]

Facility Contacts

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Daniel Sessler, MD

Role: primary

Marjolein Haveman, TP

Role: primary

Ingeborg Welters, Dr. Med.

Role: primary

Other Identifiers

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WARD-CSS international 1251

Identifier Type: -

Identifier Source: org_study_id

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