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NCT Number: NCT07690267

Continuous Vital Sign Monitoring in a Surgical Ward

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Akershus University Hospital HF

Lørenskog, Akershus, 1478, Norway

Location status: Recruiting

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Continuous Vital Sign Monitoring (CVSM)

Other

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.

Primary outcomes

  1. NEWS-2 Associated with RRT Activation

    Time frame: 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.

  2. Patient Safety Culture (N-HSOPSC 2.0)

    Time frame: 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.

  3. Nursing Staff Experiences with CVSM

    Time frame: 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.

Secondary outcomes

  1. Rapid Response Team (RRT) Activation

    Time frame: Up to 12 months after implementation

    Number of Rapid Response Team (RRT) activation

  2. Unplanned Transfers to Higher Level of Care

    Time frame: Up to 12 months after implementation

    Number of unplanned transfers to a higher level of care (intensive care unit or postoperative care unit)

  3. NEWS-2 at Time of Clinical Deterioration

    Time frame: 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.

  4. Hospital Length of Stay

    Time frame: Up to 12 months after implementation

    Total hospital length of stay (hours)

  5. Pleasure of Work and Turnover Intention

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Gørill H. Birkeli, PhD

CONTACT

[email protected]

+47 47304895

Sponsors and collaborators

Lead sponsor

University Hospital, Akershus

Other

Collaborators

  • Norwegian University of Science and Technology

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 8, 2026
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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