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

NCT07105189 | Recruiting

• 1 other identifier: WCVSM-ASD
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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. 1.The feasibility in terms of acceptability of the concept of wCVSM among orthopedic surgical ward nurses.
2. 2.The feasibility in terms of acceptability of the concept of wCVSM in patients undergoing ASD surgery.
3. 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. 4.The frequency of vital sign deviations in patients after ASD surgery using wCVSM compared to NEWS2.
5. 5.Clinical outcomes of patients undergoing ASD surgery including surgical complications, reinterventions, ICU admissions, unplanned ward transfer, and admissions to another department.

Conditions

Acceptability; ASD Surgery; Remote Monitoring; Feasibility Studies; Adult Spinal Deformity; Wireless Continuous Vital Signs Monitoring; Wireless Vital Signs Monitoring System

Outcome Measures

Primary Outcomes (1)

• Assessment of acceptability of the concept of wCVSM among orthopedic surgical ward nurses.

  USE questionnaires will be distributed to the nurses taking care of patients undergoing ASD surgery.

  At 1, 6 and 12 months after post-implementation

Secondary Outcomes (4)

• Assessment of acceptability of the concept of wCVSM in patients undergoing ASD surgery.

  up to 7 days

• Tecnical fidelity of the functioning of the continuous monitoring system

  Up to 7 days

• Frequency of deviations in vital signs in patients after ASD surgery using wCVSM compared to NEWS2

  Up to 7 days

• Assessment of clinical outcomes after ASD surgery

  Up to 30 days

Study Arms (1)

Wireless continuous vital sign monitoring in patients undergoing adult spinal deformity surgery

EXPERIMENTAL

Participants in this arm will receive a wearable wireless continuous vital sign monitoring system (CPC12S), applied after spinal deformity surgery and worn during the initial postoperative period (typically 3-5 days). The device transmits data wirelessly to a mobile application accessed by nursing staff.

Device: Wireless monitoring

Interventions

Wireless monitoring DEVICE

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.

Wireless continuous vital sign monitoring in patients undergoing adult spinal deformity surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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:

• Patients who are not proficient in the Danish language will be excluded.

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Department of Bone and Joint surgery, University hospital, Rigshospitalet, Copenhagen

Copenhagen, 2100, Denmark

RECRUITING

Central Study Contacts

Camilla Hedegaard Larsen

CONTACT

+4553651065; camilla.hedegaard.larsen@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical nurse specialist and Ph.d-student

Study Record Dates

• First Submitted: January 10, 2025
• First Posted: August 5, 2025
• Study Start: December 10, 2025
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: January 8, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Following publication of the manuscript and for five years afterwards
• Access Criteria: Following publication of the manuscript, deidentified individual participant data will be available upon reasonable request. The project team will review each request on a case-by-case basis for a period of five years.

Locations

DK (1)