RecruitingNot Applicable

Continuous Vital Sign Monitoring in a Surgical Ward

Norway9,600 participantsStarted 2025-09-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

NEWS-2 Associated with RRT Activation

Timeframe: Up to 12 months after implementation

Patient Safety Culture (N-HSOPSC 2.0)

Timeframe: Baseline, 5 months, and 12 months after implementation

Nursing Staff Experiences with CVSM

Timeframe: Approximately 6 months after implementation

Trial details

NCT IDNCT07690267

SponsorUniversity Hospital, Akershus

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-10-01

Contact for this trial

Gørill H. Birkeli, PhD

+47 47304895 gobi@ahus.no

View on ClinicalTrials.gov More Patient Monitoring trials