Multidimensional Correlation Analysis of Heart Rate Variability and Weaning Assessment Parameters in Critically Mechanically Ventilated Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- ventilator-free days(VFDs)
研究概览
简要总结
Background： Conventional weaning assessments are widely used but often affected by factors such as poor patient cooperation, neuromuscular issues, or unstable consciousness, leading to uncertainty in extubation timing. Studies have shown that HRV differs significantly between successful and failed extubation cases. However, most research features small sample sizes, focuses on single HRV indicators, and lacks integration with traditional assessments, limiting HRV's clinical application.
Effect： The study aims to develop a predictive model combining HRV and traditional weaning indicators to provide a more objective and sensitive physiological reference for ventilator weaning decisions in critical care settings.
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
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 85 years.
- •Received mechanical ventilation for more than 24 hours and clinically assessed as ready for a Spontaneous Breathing Trial (SBT).
- •Stable ECG signal quality before extubation, meeting the basic requirements for HRV analysis.
- •Obtained informed consent from the patient or their legal representative, and agreed to participate in this study and cooperate with the 72-hour follow-up after extubation.
排除标准
- •Individuals with permanent pacemakers, defibrillators, or other devices that affect monitoring data.
- •Individuals on continuous deep sedation (RAS ≤ -4) and unable to regain consciousness in the short term.
- •Individuals with severe arrhythmias or unstable cardiovascular conditions that prevent reliable HRV analysis.
- •Individuals with cognitive impairment or mental illness that prevents them from cooperating with the research process, or individuals deemed unsuitable for participation in this study by their clinicians.
结局指标
主要结局
ventilator-free days(VFDs)
时间窗: up to 3 days
Perform the extubation procedure based on clinical judgment, and record the extubation process and its success or failure in detail (successful extubation is defined as not requiring reintubation within 24 hours after extubation; and the condition should be continuously monitored for up to 72 hours after extubation). Simultaneously record the clinical outcomes after extubation, including the occurrence of VAP, ICU stay days, total hospital stay, and reintubation rate.
次要结局
未报告次要终点