Patient MonitoringNCT07690267
Continuous Vital Sign Monitoring in a Surgical Ward
An observational study of Patient Monitoring and Wearable Devices, run by University Hospital, Akershus at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Patient Monitoring, Wearable Devices, Telemonitoring
- What is being tested?
- Continuous Vital Sign Monitoring (CVSM)
- How many people
- 9,600 participants
- Where
- 1 siteNorway
- Study dates
- 1 Sep 2025to 1 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Patients with delirium.
- Patients with cognitive impairment interfering with sensor use.
- Patients who decline participation.
- Patients with allergy to electrode adhesives.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site, 1 recruiting
- Recruiting
Akershus University Hospital HF
Lørenskog, Akershus, 1478
About this study
Official 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
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.
Read the detailed description
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).
- Conditions
- Patient Monitoring, Wearable Devices, Telemonitoring, Patient Safety, Patient Deterioration, Nurses
- Being tested
- Continuous Vital Sign Monitoring (CVSM)
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Approximately 6 months after implementation
Secondary outcomes (5)
Rapid Response Team (RRT) Activation
Number of Rapid Response Team (RRT) activation
Measured: Up to 12 months after implementation
Unplanned Transfers to Higher Level of Care
Number of unplanned transfers to a higher level of care (intensive care unit or postoperative care unit)
Measured: Up to 12 months after implementation
NEWS-2 at Time of Clinical Deterioration
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.
Measured: Up to 12 months after implementation
Hospital Length of Stay
Total hospital length of stay (hours)
Measured: Up to 12 months after implementation
Pleasure of Work and Turnover Intention
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.
Measured: Baseline, 5 months, and 12 months after implementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2026
- Study start1 Sep 2025
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient MonitoringStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 9,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Akershus
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian University of Science and Technology
- Responsible party
- Principal investigator, Gørill Birkeli, University Hospital, Akershus
- Investigators
- Gørill H. Birkeli, PhD, Principal investigator, University Hospital, Akershus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07690267
- Sponsor's protocol ID
- CVSM-2026
- Status last verified
- Jul 2026
- First submitted
- 2 Jul 2026
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07690267
- Acronym / sponsor ID
- CVSM-2026
- Conditions
- Patient Monitoring, Wearable Devices, Telemonitoring, Patient Safety, Patient Deterioration, Nurses
- Keywords
- Continuous vital sign monitoring, Patient monitoring, Wearable devices, Telemonitoring, Patient safety, Patient deterioration, Early warning scores, National Early Warning Score (NEWS-2)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 9,600 participants (estimated)
- Lead sponsor
- University Hospital, AkershusUniversity, hospital or other
- Collaborators
- Norwegian University of Science and Technology
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 8 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention ward | – | Other: Continuous Vital Sign Monitoring (CVSM)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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- Patients with delirium.
- Patients with cognitive impairment interfering with sensor use.
- Patients who decline participation.
- Patients with allergy to electrode adhesives.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Intervention ward |
Primary outcome
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.
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.
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.
5 secondary outcomes
Rapid Response Team (RRT) Activation
Time frame: Up to 12 months after implementation
Unplanned Transfers to Higher Level of Care
Time frame: Up to 12 months after implementation
NEWS-2 at Time of Clinical Deterioration
Time frame: Up to 12 months after implementation
Hospital Length of Stay
Time frame: Up to 12 months after implementation
Pleasure of Work and Turnover Intention
Time frame: Baseline, 5 months, and 12 months after implementation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Further details regarding the study design, methodology, and analysis plans are available at the Open Science Framework (OSF).Link provided by the sponsor.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gørill H. Birkeli, PhD principal investigator
University Hospital, Akershus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patient Monitoring and Wearable Devices, run by University Hospital, Akershus at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gørill H. Birkeli, PhD (+47 47304895, gobi@ahus.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NEWS-2 Associated with RRT Activation (time frame: Up to 12 months after implementation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.