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

RecruitingNAAges 18 Years - anyAllCopenhagen University Hospital, Rigshospitalet
NCT07105189 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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: Usefu

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📋 Eligibility rules (as published)
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.
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What it tests

  • Wireless monitoring
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Where

1 site
Department of Bone and Joint surgery, University hospital, Rigshospitalet, Copenhagen
Copenhagen, Denmark
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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