NCT07105189 Feasibility of Wireless Continuous Vital Sign Monitoring and Impact on Patients Undergoing Adult Spinal Surgery in a General Ward
| NCT ID | NCT07105189 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Rigshospitalet, Denmark |
| Condition | Adult Spinal Deformity |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2025-12-10 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 150 participants in total. It began in 2025-12-10 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this feasibility study is to explore the use of wireless continuous vital sign monitoring in an orthopaedic setting among orthopaedic nurses and patients undergoing adult spinal deformity surgery. In addition to the standard care National Early Warning Score the participants in this study will be monitored by CPC12S a wearable sensor that is worn on the chest using electrodes measuring electrocardiography single lead (ECG), Heart rate, respiratory rate, SpO2, blood pressure and temperature. Main hypotheses: The use of wireless continuous vital sign monitoring in daily clinical practice for patients undergoing ASD surgery is feasible in terms of increased acceptability among orthopeadic surgical nurses measured over 12 months with a response rate of at least 80% with an average score of ≥5 at the last measurement in each of the four dimensions of the USE questionnaire: Usefulness, ease of use, ease of learning and satisfaction. The following parameters will be evaluated: Primary outcome: 1. The feasibility in terms of acceptability of the concept of wCVSM among orthopedic surgical ward nurses. Secondary outcomes: 2. The feasibility in terms of acceptability of the concept of wCVSM in patients undergoing ASD surgery. 3. The technical fidelity of wCVSM, assessed by data collected of vital signs, display of alerts to staff nurses and response to the alerts. 4. The frequency of vital sign deviations in patients after ASD surgery using wCVSM compared to NEWS2. 5. Clinical outcomes of patients undergoing ASD surgery including surgical complications, reinterventions, ICU admissions, unplanned ward transfer, and admissions to another department.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07105189 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Adult Spinal Deformity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07105189 currently recruiting?
Yes, NCT07105189 is actively recruiting participants. Contact the research team at camilla.hedegaard.larsen@regionh.dk for enrollment information.
Where is the NCT07105189 trial being conducted?
This trial is being conducted at Copenhagen, Denmark.
Who is sponsoring the NCT07105189 clinical trial?
NCT07105189 is sponsored by Rigshospitalet, Denmark. The trial plans to enroll 150 participants.