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
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to explore the use of wireless continuous vital sign monitoring (wCVSM) in an orthopaedic setting among nurses and patients undergoing adult spinal deformity (ASD) surgery. ASD surgery carries a high risk of complications and long recovery, with patients susceptible to issues like electrolyte imbalance, cardiac arrhythmia, and severe postoperative pain. The study evaluates the feasibility and acceptability of continuous monitoring compared to the standard intermittent National Early Warning Score 2 (NEWS2) system, focusing on its potential to improve safety and clinical outcomes. Participants will be monitored using the CPC12S device, a wearable sensor placed on the chest that measures multiple vital signs including ECG, heart rate, respiratory rate, oxygen saturation, blood pressure, and temperature. Data are updated every 20 seconds and transmitted wirelessly to a mobile application accessed by nursing staff. The device is worn during the initial postoperative period, typically 3 to 5 days. Nurses' acceptability of the system is measured over 12 months, while patient acceptability and technical fidelity are assessed during the postoperative hospital stay. Throughout the study, researchers will collect data on vital sign deviations, alerts generated by the system, nurse responses, and clinical outcomes such as surgical complications and ICU admissions. Nurses will complete questionnaires at baseline, 6 months, and 12 months to assess usefulness and satisfaction. Patients will fill usability surveys before discharge. The study includes monitoring the frequency of deviations detected by wCVSM versus NEWS2 and analyzing the impact on patient safety and clinical management over a follow-up period up to 30 days.
CONDITIONS
Brief 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...
- Adults aged 18 years or older scheduled for adult spinal deformity surgery
- Expected postoperative hospital stay longer than 3 days
- Surgery involving posterior instrumented fusion of at least five spinal levels including the pelvis
- Registered nurses and nurse assistants working on the orthopedic ward during the study who have experience with continuous vital sign monitoring
- Nurses and nurse assistants must be proficient in Danish and include both sexes with varied education and experience levels
You will not qualify if you...
- Patients unable to wear continuous monitoring due to having a pacemaker or allergy
- Patients not proficient in the Danish language
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Typically 3 to 5 days
Participants undergo adult spinal deformity surgery followed by immediate post-operative care including standard monitoring.
Hospital stay during surgery and immediate recovery
Duration - Typically 3 to 5 days post-surgery
Participants wear a wireless continuous vital sign monitoring system (CPC12S) to continuously monitor vital signs such as heart rate, respiratory rate, SpO2, blood pressure, and temperature postoperatively.
Continuous monitoring during hospital stay
Duration - Up to 30 days
Participants complete patient acceptability questionnaires before discharge, and clinical outcomes including complications, reinterventions, and readmissions are monitored up to 30 days after surgery.
1 visit before discharge and monitoring up to 30 days
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
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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