Agreement Between Standard and Continuous Wireless Vital Sign Measurements Following Major Abdominal Surgery: A Clinical Comparison Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Heart rate comparisons
研究概览
简要总结
Patients undergoing major surgery are at risk of postoperative complications. Continuous wireless monitoring outside the post-anesthesia or intensive care units may enable early detection of patient deterioration, but good accuracy of measurements is required.
This validation study, which is part of the WARD-SX project, aimed to assess the agreement between vital signs recorded by standard and novel wireless devices
详细描述
Patients undergoing major surgery are at risk of postoperative complications. Complications may be preceded by abnormal vital signs. Standard monitoring at general wards is intermittent and manual, leaving the patients unobserved for extended periods.
The chance to enhance monitoring has arisen with recent technological advances in the form of small wearable and wireless devices that continuously record vital signs. Wearable devices enable continuous monitoring outside the intensive care unit and post-anesthesia care unit, thus enabling early detection of patient deterioration. However, before implementing such devices in hospital settings, good accuracy, and precision of measurements is required.
This validation study, which is part of the WARD-SX project, aimed to assess the agreement between vital signs recorded by standard and novel wireless devices
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 60 Years 至 110 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥60 years, scheduled for major abdominal cancer surgery with planned PACU admission.
- •Estimated surgical intervention duration ≥2 hours.
排除标准
- •Implanted cardioverter defibrillator or pacemaker, allergy to study devices, severe cognitive impairment assessed by Mini-Mental State Examination ≤24, or inability to cooperate in wearing the wireless monitoring equipment.
结局指标
主要结局
Heart rate comparisons
时间窗: 1.5 hours (measurement interval every 15 min)
Heart rate (beats per minute) measurements compared between Isansys Lifetouch and standard monitoring (Phillips IntelliVue). Analysed using Bland Altman (BA) analysis to measure mean diference and limits of agreement between to methods. The BA analysis is corrected for repeated measures within each subject.
SpO2 measurements comparisons wireless vs. invasive
时间窗: 1.5 hours
SpO2 (percent) measurements compared between Nonin WristOx 3150 and arterial arterial oxygen saturation. Analysed using Bland Altman (BA) analysis to measure mean difference and limits of agreement between to methods. The BA analysis is corrected for repeated measures within each subject.
Blood pressure comparisons, wireless vs. arterial BP
时间窗: 1.5 hours
Systolic and diastolic (mmHg) measurements compared between Meditech BlueBp-05 and invasive arterial blood pressure. Analysed using Bland Altman (BA) analysis to measure mean difference and limits of agreement between to methods. The BA analysis is corrected for repeated measures within each subject.
Respiratory rate comparisons
时间窗: 1.5 hours
Respiratory rate (breaths per minute) measurements compared between Isansys Lifetouch and observed counted measurements. Analysed using Bland Altman (BA) analysis to measure mean difference and limits of agreement between to methods. The BA analysis is corrected for repeated measures within each subject.
SpO2 measurements comparisons wireless vs. standard
时间窗: 1.5 hours (measurement interval every 15 min)
SpO2 (percent) measurements compared between Nonin WristOx 3150 and standard monitoring. Analysed using Bland Altman (BA) analysis to measure mean difference and limits of agreement between to methods. The BA analysis is corrected for repeated measures within each subject.
Pulse rate comparisons
时间窗: 1.5 hours
Pulse rate measurements (beats per minute) measures compared between Nonin WristOx 3150 and standard monitoring. Analysed using Bland Altman (BA) analysis to measure mean difference and limits of agreement between to methods. The BA analysis is corrected for repeated measures within each subject.
Blood pressure comparisons wireless vs. standard
时间窗: 1.5 hours, every 15 min
Blood pressure (mmHg) measurements compared between Meditech BlueBp-05 and standard monitoring. Analysed using Bland Altman (BA) analysis to measure mean difference and limits of agreement between to methods. The BA analysis is corrected for repeated measures within each subject.
次要结局
未报告次要终点
研究者
Camilla Haahr-Raunkjaer
MD.
Rigshospitalet, Denmark