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Continuous Vital Sign Monitoring in a Surgical Ward

8. Juli 2026 aktualisiert von: Gørill Birkeli, University Hospital, Akershus

Continuous Vital Sign Monitoring in a Norwegian Hospital Surgical Ward: A Multi-Method Study of Patient Outcomes, Patient Safety Culture, and Nursing Staff Experiences

Unsafe patient care remains a major contributor to global morbidity and mortality. In surgical wards, postoperative patients are typically monitored intermittently using the National Early Warning Score (NEWS-2), leaving periods during which clinical deterioration may go undetected. Continuous vital sign monitoring (CVSM) using wearable sensors offers the potential for earlier identification of deterioration compared with intermittent assessments.

CVSM was introduced in a hospital ward as part of a hospital-initiated pilot implementation and is used alongside standard monitoring with NEWS-2. The purpose of the study is to evaluate this implementation.

This observational study uses a pragmatic, quasi-experimental, multi-method, longitudinal design. The overall aims of the study are to evaluate the impact of CVSM implementation on patient outcomes, to explore healthcare professionals' perceptions of patient safety culture, turnover intention and pleasure of work, and to describe their experiences with implementation.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

Unsafe care is a major contributor to global morbidity and mortality. In surgical wards, postoperative patients are typically monitored intermittently using the National Early Warning Score (NEWS-2), which may leave periods during which changes in vital signs go undetected, potentially increasing the risk of clinical deterioration. Continuous vital sign monitoring (CVSM) using wearable sensors may enable earlier detection of deterioration compared with intermittent monitoring.

This study evaluates the implementation of CVSM using 16 wearable sensors in a 29-bed gastro-surgical ward beginning in September 2025. CVSM is based on wearable sensors that continuously monitor patients' respiratory rate, heart rate, and oxygen saturation. The system transfers data to the electronic health record, and alerts are generated when predefined thresholds are exceeded and delivered to nursing staff via smartphones and workstation monitors. CVSM is implemented in addition to usual care, including intermittent NEWS-2 monitoring, in accordance with hospital protocol.

The intervention was implemented as part of a hospital-initiated pilot programme that was supported by hospital management and aimed to evaluate the feasibility and potential effects of broader CVSM adoption. The intervention ward was selected by the hospital for pragmatic reasons, based on managers' agreement to implement CVSM. Implementation was overseen by a hospital-appointed project manager. Members of the research team participated in implementation meetings and provided input on potential implementation strategies. However, responsibility for implementation decisions remained with hospital management and the clinical departments, and implementation was primarily guided by clinical priorities and operational constraints within the hospital. The primary role of the research team was to support and conduct the empirical evaluation of the intervention and its implementation.

It is hypothesised that CVSM may enable earlier detection of patient deterioration compared with intermittent monitoring alone and thereby influence patient outcomes. It is also hypothesised that CVSM may influence healthcare professionals' perceptions of patient safety culture, turnover intention, and work-related well-being. The study will further generate knowledge about healthcare professionals' experiences with the implementation.

While data collection for the studies on patient safety culture and nurses' experiences with implementation has started, the patient outcome study is currently awaiting a decision from the Norwegian Directorate of Health. Data collection for this study has not yet commenced. The studies on patient safety culture and nurses' experiences with implementation have been preregistered in the Open Science Framework (OSF).

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

9600

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

  • Name: Gørill H. Birkeli, PhD
  • Telefonnummer: +47 47304895
  • E-Mail: gobi@ahus.no

Studienorte

  • Norwegen
    • Akershus
      • Lørenskog, Akershus, Norwegen, 1478
        • Rekrutierung
        • Akershus University Hospital HF

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Ja

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

The study population includes adult patients admitted to a gastro-surgical ward before and after implementation of continuous vital sign monitoring (CVSM), as well as adult patients admitted to a non-equivalent comparison ward at the same Norwegian teaching hospital. The study population also includes healthcare professionals working in these wards.

Beschreibung

Inclusion Criteria:

  • Patients aged 18 years or older admitted to the gastro-surgical ward.
  • Healthcare professionals aged 18 years or older employed in the participating wards for survey participation.
  • Nursing staff with at least 6 months of work experience and experience using CVSM for participation in qualitative focus group interviews.

Exclusion Criteria:

  • Patients with delirium.
  • Patients with cognitive impairment interfering with sensor use.
  • Patients who decline participation.
  • Patients with allergy to electrode adhesives.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
Intervention / Behandlung
Intervention ward

All patients admitted to the gastro-surgical ward during the 12-month implementation of continuous vital sign monitoring (CVSM).

Healthcare professionals (physicians, nursing assistants, and registered nurses) working predominantly in the intervention ward.
Sonstiges: Continuous Vital Sign Monitoring (CVSM)
The intervention consists of continuous vital sign monitoring (CVSM) using wearable sensors applied to patients. A total of 16 sensors are implemented in a 29-bed gastro-surgical ward. The system continuously records patients' vital signs and transfers data to the electronic health record. Alerts are generated when predefined thresholds are exceeded and are delivered to nursing staff via smartphones and workstation monitors. The intervention is implemented in addition to usual practice with intermittent monitoring using the National Early Warning Score (NEWS-2), according to hospital protocol. Nursing staff receive training prior to implementation, and clinical responses to alerts are managed in accordance with hospital procedures. The intervention was implemented from September 2025 and continues during the study period.
Control group
All patients admitted to the same gastro surgical ward will be its own control group 1 year before the intervention. Patients received standard care before the intervention. This means that relevant outcomes during the implementation (2026) is compared to the same outcomes before the intervention (i.e., 2024) in the same ward.
Non-equivalent comparison group

All patients admitted to a non-equivalent comparison ward for the period spanning from January 1, 2024, to January 1, 2025, and from October 1, 2025, to October 1, 2026, during which CVSM was not implemented.

Healthcare professionals (physicians, nursing assistants, and registered nurses) working predominantly in a comparable gastro-surgical ward at the same hospital during the 12-month implementation period of CVSM in the intervention ward.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
NEWS-2 Associated with RRT Activation
Zeitfenster: Up to 12 months after implementation
National Early Warning Score 2 (NEWS2) associated with rapid response team (RRT) activation. NEWS2 is a physiological deterioration score ranging from 0 to 20 points. Higher scores indicate greater physiological deterioration and worse clinical status. According to hospital protocol, RRT consultation is recommended at NEWS2 ≥7. NEWS2 at the time of RRT activation will be assessed.
Up to 12 months after implementation
Patient Safety Culture (N-HSOPSC 2.0)
Zeitfenster: Baseline, 5 months, and 12 months after implementation
Healthcare professionals' perceptions of patient safety culture measured as changes in the ten composite dimensions and two single-item measures of the Norwegian Hospital Survey on Patient Safety Culture (N-HSOPSC 2.0). Responses are recorded using 5-point Likert scales ranging from 1 to 5. Higher scores indicate more positive perceptions of patient safety culture.
Baseline, 5 months, and 12 months after implementation
Nursing Staff Experiences with CVSM
Zeitfenster: Approximately 6 months after implementation
Nursing staff experiences with the implementation and perceived usefulness of continuous vital sign monitoring (CVSM) for patient safety, explored through qualitative focus group interviews. This is a qualitative outcome measure and no numerical score will be calculated.
Approximately 6 months after implementation

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Rapid Response Team (RRT) Activation
Zeitfenster: Up to 12 months after implementation
Number of Rapid Response Team (RRT) activation
Up to 12 months after implementation
Unplanned Transfers to Higher Level of Care
Zeitfenster: Up to 12 months after implementation
Number of unplanned transfers to a higher level of care (intensive care unit or postoperative care unit)
Up to 12 months after implementation
Hospital Length of Stay
Zeitfenster: Up to 12 months after implementation
Total hospital length of stay (hours)
Up to 12 months after implementation
NEWS-2 at Time of Clinical Deterioration
Zeitfenster: Up to 12 months after implementation
National Early Warning Score 2 (NEWS2) measured at the time of unplanned transfer to a higher level of care. NEWS2 is a physiological deterioration score ranging from 0 to 20 points. Higher scores indicate greater physiological deterioration and worse clinical status.
Up to 12 months after implementation
Pleasure of Work and Turnover Intention
Zeitfenster: Baseline, 5 months, and 12 months after implementation
Healthcare professionals' perceived pleasure of work and turnover intention measured using validated composite measures. Pleasure of work is assessed on a 4-point Likert scale (1-4) and turnover intention on a 5-point Likert scale (1-5). Higher scores indicate greater pleasure of work and lower turnover intention.
Baseline, 5 months, and 12 months after implementation

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University Hospital, Akershus

Mitarbeiter

Norwegian University of Science and Technology

Ermittler

  • Hauptermittler: Gørill H. Birkeli, PhD, University Hospital, Akershus

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Nützliche Links

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

1. September 2025

Primärer Abschluss (Geschätzt)

1. Oktober 2026

Studienabschluss (Geschätzt)

1. Oktober 2026

Studienanmeldedaten

Zuerst eingereicht

2. Juli 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

2. Juli 2026

Zuerst gepostet (Tatsächlich)

8. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

9. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

8. Juli 2026

Zuletzt verifiziert

1. Juli 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Andere Studien-ID-Nummern

  • CVSM-2026

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

Individual participant data (IPD) will not be shared due to legal and ethical restrictions related to the use of sensitive patient and healthcare professional data. Study documents such as the protocol will be publicly available.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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