End-Expiratory Diaphragmatic Residual Contraction Index for Identifying Intrinsic PEEP and Assisting PEEP Titration: A Prospective Physiological Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- Diagnostic Efficacy of EDRC-AUC for Identifying Clinically Significant Dynamic Intrinsic PEEP
研究概览
简要总结
This study proposes the End-expiratory Diaphragmatic Residual Contraction (EDRC) index to quantify residual diaphragmatic activity at end-expiration during Pressure Support Ventilation (PSV) mode. The study aims to validate the relationship between EDRC and dynamic intrinsic PEEP (PEEPi), triggering load, patient-ventilator asynchrony, and PEEP responsiveness through a brief, standardized PEEP titration trial conducted within a clinically safe range. This will provide a basis for subsequent individualized PEEP setting guided by EDRC.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •Age ≥ 18 years. Patients receiving invasive mechanical ventilation in Pressure Support Ventilation (PSV) mode.
- •Clinically assessed as having a risk of dynamic intrinsic PEEP (PEEPi,dyn) or experiencing difficult weaning from mechanical ventilation.
- •Presence of an indwelling esophageal balloon catheter (for reference standard measurements).
- •Provision of written informed consent from the patient or legally authorized representative.
排除标准
- •Pregnancy or lactation. Known esophageal diseases (e.g., esophageal varices, strictures, recent esophageal surgery) or contraindications to esophageal catheter placement.
- •Severe hemodynamic instability (e.g., requiring high-dose vasoactive support, uncontrolled arrhythmias).
- •Severe hypoxemia (PaO2/FiO2 < 100 mmHg) or severe hypercapnia with hemodynamic compromise at baseline.
- •Conditions precluding ultrasound assessment of the diaphragm (e.g., extensive chest wall trauma, large pleural effusion, severe subcutaneous emphysema).
- •Active spontaneous breathing with severe patient-ventilator asynchrony that cannot be stabilized during the trial.
- •Anticipated extubation or withdrawal of life-sustaining treatment within the next 24 hours.
- •Participation in another interventional clinical trial within the last 30 days.
研究组 & 干预措施
Patients Undergoing PEEP Step Trial and EDRC Assessment
All enrolled patients will receive a standardized, short-term PEEP step trial while in Pressure Support Ventilation (PSV) mode. The trial consists of sequentially applying PEEP levels of Baseline, -2, +2, +4, and +6 cmH2O relative to the set PEEP. At each step, respiratory mechanics and patient-ventilator synchrony will be monitored. The primary intervention of interest is the assessment of End-Expiratory Diaphragmatic Residual Contraction (EDRC) via ultrasound to identify the presence of intrinsic PEEP (PEEPi) and to determine the optimal level of extrinsic PEEP that minimizes diaphragmatic effort and asynchrony.
干预措施: Short-term PEEP Step Trial and EDRC Ultrasound Assessment (Device)
结局指标
主要结局
Diagnostic Efficacy of EDRC-AUC for Identifying Clinically Significant Dynamic Intrinsic PEEP
时间窗: During the short-term PEEP step trial (each PEEP level is maintained for 5-10 minutes)
The primary outcome is the diagnostic efficacy of the End-Expiratory Diaphragmatic Residual Contraction Area Under the Curve (EDRC-AUC) in identifying clinically significant dynamic intrinsic PEEP (PEEPi,dyn ≥ 5 cmH2O) in patients undergoing Pressure Support Ventilation (PSV). The diagnostic performance will be evaluated using Receiver Operating Characteristic (ROC) curve analysis, reporting the Area Under the Curve (AUC), optimal cut-off value, sensitivity, specificity, positive predictive value, and negative predictive value, with esophageal manometry and flow curves as the reference standard.
次要结局
- Correlation between EDRC-AUC and Respiratory Drive/Load Indices(During the short-term PEEP step trial (each PEEP level maintained for 5-10 minutes) and within 30 minutes post-trial)
- Incidence of Patient-Ventilator Asynchrony Events(During the short-term PEEP step trial (each PEEP level maintained for 5-10 minutes) and within 30 minutes post-trial.)
- Agreement between EDRC-Guided PEEP and Esophageal Manometry-Guided PEEP(During the short-term PEEP step trial (each PEEP level maintained for 5-10 minutes) and within 30 minutes post-trial.)
- Trends in Diaphragmatic Contraction Dynamics Across PEEP Levels(During the short-term PEEP step trial (each PEEP level maintained for 5-10 minutes) and within 30 minutes post-trial.)
- Feasibility and Inter-Observer Reliability of EDRC Ultrasound Measurements(During the short-term PEEP step trial (each PEEP level maintained for 5-10 minutes) and within 30 minutes post-trial.)
- Adverse Events During the PEEP Step Trial(During the short-term PEEP step trial (each PEEP level maintained for 5-10 minutes) and within 30 minutes post-trial.)
研究者
Huiqing Ge
Director of Respiratory Medicine
Sir Run Run Shaw Hospital