Continuous Vital Sign Monitoring in a Surgical Ward

NCT07690267 | Recruiting

• 1 other identifier: CVSM-2026
• Study Type: observational
• Target: 9,600
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Telemonitoring; Patient Safety; Nurses; Implementation; Patient Monitoring; Wearable Devices; Healthcare Professionals; Patient Deterioration; Work-related Outcomes; Implementation Research

Keywords

Continuous vital sign monitoring; Patient monitoring; Wearable devices; Telemonitoring; Patient safety; Patient deterioration; Early warning scores; National Early Warning Score (NEWS-2); Nurses; Healthcare professionals; Patient safety culture; Hospital Survey on Patient Safety Culture (HSOPSC 2.0); Employee motivation; Work-related outcomes; Implementation; Technology implementation; Quasi-experimental design; Focus group interview; qualitative study; SEIPS; Digital health; Gastro-surgical ward; Postoperative patients

Outcome Measures

Primary Outcomes (3)

• NEWS-2 Associated with RRT Activation

  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)

  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

  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

Secondary Outcomes (5)

• Rapid Response Team (RRT) Activation

  Up to 12 months after implementation

• Unplanned Transfers to Higher Level of Care

  Up to 12 months after implementation

• NEWS-2 at Time of Clinical Deterioration

  Up to 12 months after implementation

• Hospital Length of Stay

  Up to 12 months after implementation

• Pleasure of Work and Turnover Intention

  Baseline, 5 months, and 12 months after implementation

Study Arms (3)

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.

Other: Continuous Vital Sign Monitoring (CVSM)

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.

Interventions

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.

Intervention ward

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Akershus: lead
• Norwegian University of Science and Technology: collaborator

Study Sites (1)

Akershus University Hospital HF

Lørenskog, Akershus, 1478, Norway

RECRUITING

Related Links

• Further details regarding the study design, methodology, and analysis plans are available at the Open Science Framework (OSF).

Study Officials

• Gørill H. Birkeli, PhD

  University Hospital, Akershus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gørill H. Birkeli, PhD

CONTACT

+47 47304895; gobi@ahus.no

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Advisor, Administration; Postdoctoral Researcher

Study Record Dates

• First Submitted: July 2, 2026
• First Posted: July 8, 2026
• Study Start: September 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: July 9, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)