Study on Wireless Continuous Vital Sign Monitoring in Adults Undergoing Spinal Deformity Surgery and Its Effects in a Hospital Ward

What this Trial Is About

This research investigates the use of wireless continuous vital sign monitoring in an orthopedic setting, focusing on orthopedic nurses and patients undergoing adult spinal deformity ASD surgery. The study aims to assess the feasibility and acceptability of this technology compared to the standard National Early Warning Score 2 NEWS2 system, which currently uses intermittent vital sign measurements. ASD surgery patients face high complication rates and complex postoperative recovery, making timely detection of clinical deterioration vital for patient safety. Participants in this single-arm feasibility study will use the CPC12S, a wearable sensor placed on the chest that continuously records vital signs such as single-lead electrocardiography ECG, heart rate, respiratory rate, oxygen saturation SpO2, blood pressure, and temperature. Data are updated every 20 seconds and transmitted wirelessly to nurses mobile devices via the WARD-CSS application, which helps detect patient deterioration in real time. Patients will wear the device during the initial postoperative period, typically 3 to 5 days. Nurses and nurses assistants on the orthopedic ward will also participate by assessing the acceptability of this monitoring approach over a 12-month period. During the study, patients will receive continuous monitoring alongside standard care, while nurses will complete questionnaires at baseline, 6 months, and 12 months to evaluate the systems usefulness, ease of use, and satisfaction. Researchers will analyze technical data for system performance, alert frequency, and nurse responses. They will also compare vital sign deviations detected by the wireless system versus NEWS2 and assess clinical outcomes such as surgical complications, reinterventions, and ICU admissions up to 30 days after surgery. Participation will extend up to one year for nurse assessments and up to 30 days for patient clinical outcomes.

Feasibility of Wireless Continuous Vital Sign Monitoring and Impact on Patients Undergoing Adult Spinal Surgery in a General Ward