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

Condition(s) studied

Investigational drug(s) / intervention(s)

Wireless monitoring: Patients included in the study will be continuous monitored by CPC12S is 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. The system calculates the heart rate by analysing R-peaks of QRS-complexes in the raw ECG data. Respiratory rate is recorded using impedance pneumography. SpO2 is determined by analysing the photoplethysmogram (PPG) wave. Blood pressure is derived by calculating the pulse transit time (PTT) using R-peaks from the QRS complexes, peaks in the photoplethysmogram (PPG) pulse waves, and timing of the second heart-tone corresponding to the dicrotic notch, measured by a stethoscope in the device. Temperature is measured by a thermistor placed in the axilla. Vital signs are updated every 20 seconds and measurements are transmitted via Bluetooth to an Android cell phone that is uploading the data via WIFI to a secured server.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Assessment of acceptability of the concept of wCVSM among orthopedic surgical ward nurses. — At 1, 6 and 12 months after post-implementation
  USE questionnaires will be distributed to the nurses taking care of patients undergoing ASD surgery.

Trial sites (1)

More Copenhagen University Hospital, Rigshospitalet trials in Denmark

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