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

Recruiting now · Not applicable

Conditions studied: Adult Spinal Deformity, Wireless Continuous Vital Signs Monitoring, Wireless Vital Signs Monitoring System, Acceptability, ASD Surgery, Remote Monitoring, Feasibility Studies

In brief

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.

Key facts

Study ID: NCT07105189
Run by: Rigshospitalet, Denmark
People needed: 150
Starts: 2025-12-10
Expected to finish: 2027-01-31
Last updated by the study team: 2026-07-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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 is running

Department of Bone and Joint surgery, University hospital, Rigshospitalet, Copenhagen — Copenhagen, Denmark (enrolling)

Full record on ClinicalTrials.gov

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