Regional Diaphragmatic Synchrony Index for Predicting Weaning Outcomes During Pressure Support Ventilation Spontaneous Breathing Trials: A Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 110
- 主要终点
- Rate of first-attempt weaning failure
研究概览
简要总结
The primary aim of this study is to evaluate the predictive value of the inspiratory regional diaphragmatic synchrony index (RDSI-insp) during PSV-SBT for first-attempt weaning failure. Secondary objectives include: (1) assessing the correlation between RDSI-insp and conventional respiratory mechanics and diaphragmatic ultrasound parameters such as RSBI, MIP/NIF, VC, CPF, P0.1, DE, and DTF; (2) comparing differences in RDSI and DPSI between successful and failed weaning groups during inspiration, end-inspiration, and expiration; (3) exploring the association of anterior diaphragmatic dyssynchrony index, posterior/crural dyssynchrony index, and regional time-to-peak dispersion with weaning outcomes; and (4) evaluating the feasibility, analyzable image rate, and repeatability of diaphragmatic speckle-tracking and RDSI calculation in patients undergoing PSV-SBT.
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: Age ≥ 18 years.
- •Mechanical Ventilation Duration: Receiving invasive mechanical ventilation for ≥ 24 hours.
- •Weaning Readiness: The attending physician has determined that the patient meets the criteria for weaning assessment and plans to conduct a Spontaneous Breathing Trial (SBT) under Pressure Support Ventilation (PSV) mode.
- •Hemodynamic Stability: Hemodynamically stable prior to the SBT, defined as a mean arterial pressure (MAP) ≥ 65 mmHg, or requiring only low-dose vasopressor support.
- •Oxygenation Criteria: Oxygenation status permits an SBT, typically defined as FiO2 ≤ 0.60 and PEEP ≤ 10 cmH2O, or meeting the standard weaning assessment criteria of the participating institution.
排除标准
- •Known or highly suspected phrenic nerve injury, or unilateral/bilateral diaphragmatic paralysis.
- •Neuromuscular diseases causing severely restricted spontaneous breathing capacity, as judged by the investigator to be unsuitable for RDSI analysis.
- •Recent chest or upper abdominal surgery, open trauma, skin infection, or extensive dressing coverage that prevents obtaining a reliable diaphragm ultrasound window.
- •Significant agitation or severe patient-ventilator asynchrony that prevents the acquisition of continuous and stable respiratory cycles.
- •Undrained pneumothorax, or conditions deemed unsuitable for ultrasound examination as judged by the attending physician.
- •Pregnant patients.
- •The patient or their legally authorized representative refuses to participate in the study.
结局指标
主要结局
Rate of first-attempt weaning failure
时间窗: Up to 48 hours post-extubation (or duration of the first PSV-SBT if failed)
First-attempt weaning failure, defined as failure of the first PSV-SBT, or extubation following a successful SBT but requiring reintubation within 48 hours due to respiratory failure or failure of airway protection.
次要结局
- Rescue NIV/HFNC within 48 or 72 hours post-extubation(- Up to 72 hours post-extubation)
- - Rescue NIV/HFNC within 48 or 72 hours post-extubation(- Up to 48 hours or 72 hours post-extubation)
- - Ventilator-free days at 28 days (D28)(- Up to 28 days post-enrollment)
- - Length of stay in the ICU and hospital(From the date of randomization until the date of ICU discharge or hospital discharge, whichever came first, assessed up to 12 months.)
- - ICU mortality and in-hospital mortality(From the date of randomization until the date of ICU discharge or death, whichever came first, assessed up to 12 months.)
- - Correlation between RDSI and conventional respiratory mechanics/diaphragm ultrasound parameters(At the end of the first PSV-SBT (approximately 30 to 120 minutes post-initiation))
- - Feasibility and reliability of RDSI image acquisition and speckle tracking(At the end of the first PSV-SBT, up to 120 minutes post-initiation (upon image completion))
研究者
Huiqing Ge
Director of Respiratory Medicine
Sir Run Run Shaw Hospital