Feasibility of Wireless Continuous Vital Sign Monitoring and Impact on Patients Undergoing Adult Spinal Surgery in a General Ward
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Assessment of acceptability of the concept of wCVSM among orthopedic surgical ward nurses.
研究概览
简要总结
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:
- 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.
详细描述
Patients undergoing adult spinal deformity surgery (ASD) is associated with high complication rate and long postoperative recovery (Bess et al., 2023). Patients undergoing ASD surgery are particularly susceptible to adverse events such as electrolyte imbalance, cardiac arrhythmia, anemia, hypotension, fever of unknown origin (Karstensen et al., 2016; Solumsmoen et al., 2021). Additionally, patients undergoing ASD surgery is also associated with severe postoperative pain, often requiring high levels of pain medication (Lamperti et al., 2017; Waelkens et al., 2021), there can lead to decreased respiration rate, sedation, and dizziness (Benyamin et al., 2008).Patients undergoing ASD surgery have a readmission percent within 30 days of 11,8 % and a 2-year all-cause mortality of 3% (Bari et al., 2020).
To ensure safety in patients undergoing ASD surgery, nurses must monitor vital signs to assess patients' health condition and act promptly when signs of clinical deterioration become evident. NEWS2 system is used to identify these early signs of clinical deterioration (Smith et al., 2019). The scoring system relies on six simple physiological parameters, including blood pressure, pulse, respiratory rate, peripheral oxygen saturation, temperature, level of consciousness and an associated algorithm (Smith et al., 2019). Since measurements with NEWS2 are intermittent, they often provide a temporary view of the patient's condition, and the system may therefore overlook changes in the patient's condition that occur between measurement (Downey et al., 2017).
Wireless continuous vital sign monitoring (wCVSM) offers an alternative to intermittent measurements. wCVSM systems can be defined as wearable technologies that enable continuous, real-time vital sign monitoring without direct contact between patients and health-care providers. These systems transmit vital sign data to an application on the nurses´ mobile phones, enabling the recognition of clinical deterioration in real time and facilitating a prompt response to patients' needs (Haahr-Raunkjaer et al., 2022; Leenen et al., 2020). To evaluate the feasibility of wCVSM, it is essential to assess its acceptability among orthopaedic surgical nurses and patients undergoing ASD surgery. Their perceptions and willingness to adopt this technology are essential for ensuring its practical integration, consistent use, and long-term sustainability in enhancing clinical outcomes and patient safety.
This study will contribute to our understanding of wCVSM's potential to enhance patient safety, its applicability in clinical practice, and provide necessary considerations when implementing new technological equipment.
In the current study patients undergoing ASD Surgery will, in addition to standard care the National Early Warning Score 2 (NEWS2) be monitored by wireless continuous vital sign monitoring (wCVSM) using the multiparameter ambulatory telemonitoring system CPC12S system and WARD-CSS application postoperatively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Wireless continuous vital sign monitoring in patients undergoing adult spinal deformity surgery
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.
干预措施: Wireless monitoring (Device)
结局指标
主要结局
Assessment of acceptability of the concept of wCVSM among orthopedic surgical ward nurses.
时间窗: At 1, 6 and 12 months after post-implementation
USE questionnaires will be distributed to the nurses taking care of patients undergoing ASD surgery.
Assessment of acceptability of the concept of wCVSM among orthopedic surgical ward nurses.
时间窗: At 1, 6 and 12 months after post-implementation
USE questionnaires will be distributed to the nurses taking care of patients undergoing ASD surgery.
次要结局
- 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)
- 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)
研究者
Camilla Hedegaard Larsen
Clinical nurse specialist and Ph.d-student
Rigshospitalet, Denmark
