End-Expiratory Diaphragmatic Residual Contraction Index for Identifying Intrinsic PEEP and Assisting PEEP Titration: A Prospective Physiological Study
研究概览
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名：Huiqing Ge, MD
- 电话号码：+8613588706787
- 邮箱：gehq@zju.edu.cn
研究联系人备份
- 姓名：YIqing Xu, Master
- 电话号码：+86 13634115344
- 邮箱：xuyiqing@srrsh.com
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
取样方法
研究人群
The study population will consist of adult patients ($\ge$ 18 years) admitted to the Intensive Care Unit (ICU) who are receiving invasive mechanical ventilation in Pressure Support Ventilation (PSV) mode. Participants will be recruited from the ICU at [Insert Name of Hospital/Institution].
The population is characterized by patients who are clinically assessed as having a risk of dynamic intrinsic PEEP (PEEPi,dyn) or are undergoing a spontaneous breathing trial (SBT) as part of the weaning process. All enrolled patients will have an indwelling esophageal balloon catheter placed for the measurement of esophageal pressure (Pes), which serves as the reference standard for respiratory mechanics.
Patients will be screened for eligibility based on hemodynamic stability and the ability to tolerate the study procedures. Specific exclusion criteria include pregnancy, severe esophageal pathology, severe hypoxemia, and conditions precluding diaphragmatic ultrasound imaging (e.g., chest wall tra
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
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.
|
This intervention involves a standardized, short-term PEEP step trial combined with a novel physiological assessment.
During the trial, external PEEP is systematically adjusted in 2 cmH2O increments (Baseline, -2, +2, +4, +6 cmH2O) while maintaining stable Pressure Support Ventilation (PSV) settings.
Simultaneously, the End-Expiratory Diaphragmatic Residual Contraction (EDRC) index is evaluated using diaphragm ultrasound speckle tracking.
This distinguishes the intervention by providing a non-invasive, real-time quantification of residual diaphragmatic tension at end-expiration, which serves as a surrogate marker for dynamic intrinsic PEEP (PEEPi) and trigger load, distinguishing it from traditional static measurements or esophageal manometry alone.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Diagnostic Efficacy of EDRC-AUC for Identifying Clinically Significant Dynamic Intrinsic PEEP
大体时间：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.
|
During the short-term PEEP step trial (each PEEP level is maintained for 5-10 minutes)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Correlation between EDRC-AUC and Respiratory Drive/Load Indices
大体时间：During the short-term PEEP step trial (each PEEP level maintained for 5-10 minutes) and within 30 minutes post-trial
|
To evaluate the correlation (using Pearson or Spearman correlation coefficients) between the End-Expiratory Diaphragmatic Residual Contraction Area Under the Curve (EDRC-AUC)
|
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
大体时间：During the short-term PEEP step trial (each PEEP level maintained for 5-10 minutes) and within 30 minutes post-trial.
|
To record and compare the total incidence and distribution of patient-ventilator asynchrony events across different PEEP levels.
Specific events include:Ineffective triggering;Double triggering;Auto-triggering;Short or long cycling.
|
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
大体时间：During the short-term PEEP step trial (each PEEP level maintained for 5-10 minutes) and within 30 minutes post-trial.
|
To compare the optimal PEEP level determined by the EDRC minimization principle with the optimal PEEP level determined by esophageal manometry (minimizing driving pressure or PTP).
Bland-Altman analysis will be used to evaluate the mean bias and limits of agreement between the two methods.
|
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
大体时间：During the short-term PEEP step trial (each PEEP level maintained for 5-10 minutes) and within 30 minutes post-trial.
|
To observe and describe the dynamic trends of diaphragm thickening fraction (DTF) and the EDRC index across all phases of the PEEP step trial (Baseline, -2, +2, +4, +6 cmH2O), assessing the bidirectional effects of extrinsic PEEP on diaphragmatic load.
|
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
大体时间：During the short-term PEEP step trial (each PEEP level maintained for 5-10 minutes) and within 30 minutes post-trial.
|
Feasibility: The proportion of patients from whom analyzable ultrasound images were successfully obtained; Reproducibility: The intra-class correlation coefficient (ICC) for EDRC-AUC measurements between different operators (inter-observer) and by the same operator at different time points (intra-observer).
|
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
大体时间：During the short-term PEEP step trial (each PEEP level maintained for 5-10 minutes) and within 30 minutes post-trial.
|
To document any clinical adverse events occurring during the PEEP titration process, including: Hemodynamic instability (e.g., systolic blood pressure decrease >20% or increased requirement for vasoactive drugs); Severe hypoxemia (SpO2 < 88% lasting >1 minute); Severe arrhythmias; Significant respiratory distress or intolerance requiring premature termination of the trial. |
During the short-term PEEP step trial (each PEEP level maintained for 5-10 minutes) and within 30 minutes post-trial.
|
合作者和调查者
出版物和有用的链接
一般刊物
- Umbrello M, Formenti P, Longhi D, Galimberti A, Piva I, Pezzi A, Mistraletti G, Marini JJ, Iapichino G. Diaphragm ultrasound as indicator of respiratory effort in critically ill patients undergoing assisted mechanical ventilation: a pilot clinical study. Crit Care. 2015 Apr 13;19(1):161. doi: 10.1186/s13054-015-0894-9.
- Haudebourg AF, Maraffi T, Tuffet S, Perier F, de Prost N, Razazi K, Mekontso Dessap A, Carteaux G. Refractory ineffective triggering during pressure support ventilation: effect of proportional assist ventilation with load-adjustable gain factors. Ann Intensive Care. 2021 Oct 20;11(1):147. doi: 10.1186/s13613-021-00935-0.
- Chao DC, Scheinhorn DJ, Stearn-Hassenpflug M. Patient-ventilator trigger asynchrony in prolonged mechanical ventilation. Chest. 1997 Dec;112(6):1592-9. doi: 10.1378/chest.112.6.1592.
- MacIntyre NR, Cheng KC, McConnell R. Applied PEEP during pressure support reduces the inspiratory threshold load of intrinsic PEEP. Chest. 1997 Jan;111(1):188-93. doi: 10.1378/chest.111.1.188.
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 20260627
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.