Actively Recruiting
Feasibility of Wireless Continuous Vital Sign Monitoring and Impact on Patients Undergoing Adult Spinal Surgery in a General Ward
Led by Rigshospitalet, Denmark · Updated on 2026-01-08
150
Participants Needed
1
Research Sites
37 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Feasibility of Wireless Continuous Vital Sign Monitoring and Impact on Patients Undergoing Adult Spinal Surgery in a General Ward
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients aged 18 years or older scheduled for adult spinal deformity surgery
- Expected postoperative hospital stay longer than 3 days
- Surgery defined as posterior instrumented fusion of at least five spinal levels including pelvis instrumentation due to degenerative spine condition
- Registered nurses and nurse assistants working on the orthopedic ward during the study with experience using wireless continuous vital sign monitoring
- Nurses and nurse assistants of all genders, varying education levels, and work experience
- Proficiency in the Danish language for nurses and nurse assistants
You will not qualify if you...
- Patients unable to wear continuous monitoring due to pacemaker or allergy
- Patients not proficient in the Danish language
AI-Screening
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Trial Site Locations
Total: 1 location
1
Department of Bone and Joint surgery, University hospital, Rigshospitalet, Copenhagen
Copenhagen, Denmark, 2100
Actively Recruiting
Research Team
C
Camilla Hedegaard Larsen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
1
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