Wireless continuous vital sign monitoring for adults after spinal deformity surgery
Official title: Feasibility of Wireless Continuous Vital Sign Monitoring and Impact on Patients Undergoing Adult Spinal Surgery in a General Ward
Run by Copenhagen University Hospital, Rigshospitalet · NCT07105189 · Data updated 2026-11-12
This project will test whether wearing a small wireless chest sensor that continuously measures heart rate, breathing rate, oxygen levels, blood pressure, and temperature helps nurses spot problems in adults recovering from spinal deformity surgery.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | Copenhagen University Hospital, Rigshospitalet Academic / other |
| Locations | 1 site (Copenhagen) |
| Status | Recruiting |
| Started | December 10, 2025 |
| Main results expected | December 31, 2026 |
| Study ends | January 31, 2027 |
| Registry record updated | July 9, 2026 |
| Trial ID | NCT07105189 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18 years) scheduled for posterior instrumented fusion of at least five spinal levels including fixation to the pelvis for spinal deformity with an expected postoperative stay >3 days and able to wear the chest sensor and communicate in Danish.
✕Probably not a fit
Patients with implanted pacemakers, adhesive allergies that prevent wearing a chest sensor, or those not proficient in Danish are excluded and unlikely to benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This single-center feasibility project enrolls adults undergoing extensive posterior spinal fusion for deformity and monitors them postoperatively with a chest-worn wearable sensor (CPC12S) alongside routine intermittent National Early Warning Score (NEWS2) checks. The wearable captures single-lead ECG, heart rate, respiratory rate, SpO2, blood pressure and temperature continuously while patients are on the general orthopaedic ward. The study measures feasibility and nurse acceptability using the USE questionnaire over 12 months and tracks clinical parameters and safety signals. Data will be used to determine whether wireless continuous vital sign monitoring is practical in daily orthopaedic care and to inform larger studies.
Why it matters
Potential benefit: If successful, continuous wireless monitoring could allow earlier detection of clinical deterioration, faster intervention, and potentially reduce complications or readmissions.
How similar studies have gone: Wireless continuous vital sign monitoring has shown promising feasibility and earlier detection in other hospital wards, but its use specifically for adult spinal deformity surgery is relatively novel and evidence is limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Included are adult patients (\>=18 years) scheduled for ASD surgery with estimated a \>3 day expected post-operative stay. ASD-surgery is defined as a posterior instrumented fusion of at least five spinal levels including instrumentation to the pelvis, caused by a degenerative condition of the spine. * Registered nurses and nurses' assistants employed at the orthopedic ward during the study period will be included if they have experience working with wCVSM during the study period. The study includes both sexes, variation of level of education and years of work experience. Included nurses and nurses' assistants should be proficient in the Danish language. Exclusion Criteria: * Exclusion criteria are patients who are unable to wear continuous monitoring due to a pacemaker or allergy. * Patients who are not proficient in the Danish language will be excluded.
Where it's running
-
Department of Bone and Joint surgery, University hospital, Rigshospitalet, Copenhagen
Copenhagen, Denmark Recruiting
Study contacts
- Study coordinator: Camilla Hedegaard Larsen
- Email: camilla.hedegaard.larsen@regionh.dk
- Phone: +4553651065
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.