Regional Diaphragmatic Synchrony Index for Predicting Weaning Outcomes During Pressure Support Ventilation Spontaneous Breathing Trials
2026年7月23日 更新者：Huiqing Ge、Sir Run Run Shaw Hospital
Regional Diaphragmatic Synchrony Index for Predicting Weaning Outcomes During Pressure Support Ventilation Spontaneous Breathing Trials: A Prospective Observational Study
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.
研究概览
研究类型
观察性的
注册 (估计的)
110
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
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
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
取样方法
概率样本
研究人群
The study population will consist of adult patients (aged 18 years and older) who have received invasive mechanical ventilation for at least 24 hours and are clinically ready for their first Spontaneous Breathing Trial (SBT) under Pressure Support Ventilation (PSV) mode.
Eligible participants must be hemodynamically stable (MAP ≥ 65 mmHg with or without low-dose vasopressors) and have adequate oxygenation (FiO2 ≤ 0.60 and PEEP ≤ 10 cmH2O) to safely undergo the SBT.
Patients with known diaphragm paralysis, inadequate ultrasound windows, severe agitation, or those who are pregnant will be excluded.
Written informed consent will be obtained from the patient or their legally authorized representative prior to enrollment.
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
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 |
|---|---|
|
Weaning Success
Patients who successfully pass the first PSV-SBT and remain free from reintubation or rescue non-invasive ventilation (NIV)/high-flow nasal cannula (HFNC) for at least 48 hours post-extubation due to respiratory failure or failure of airway protection.
|
Patients undergoing their first Spontaneous Breathing Trial (SBT) under Pressure Support Ventilation (PSV) will receive diaphragm ultrasound examinations.
The investigators will measure diaphragm excursion (DE) and thickening fraction (DTF) to calculate the Respiratory Diaphragm-SB Index (RDSI).
Conventional weaning parameters (RSBI, MIP, P0.1, etc.) will also be recorded simultaneously.
The results will be compared to predict weaning outcomes (successful extubation vs. failure/reintubation).
|
|
Weaning Failure
Patients who fail the first PSV-SBT, or those who pass the SBT but require reintubation or rescue NIV/HFNC within 48 hours post-extubation due to respiratory failure or failure of airway protection.
|
Patients undergoing their first Spontaneous Breathing Trial (SBT) under Pressure Support Ventilation (PSV) will receive diaphragm ultrasound examinations.
The investigators will measure diaphragm excursion (DE) and thickening fraction (DTF) to calculate the Respiratory Diaphragm-SB Index (RDSI).
Conventional weaning parameters (RSBI, MIP, P0.1, etc.) will also be recorded simultaneously.
The results will be compared to predict weaning outcomes (successful extubation vs. failure/reintubation).
|
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 |
|---|---|---|
|
Rate of first-attempt weaning failure
大体时间：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.
|
Up to 48 hours post-extubation (or duration of the first PSV-SBT if failed)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Rescue NIV/HFNC within 48 or 72 hours post-extubation
大体时间：- Up to 72 hours post-extubation
|
- Proportion of patients requiring reintubation for any reason (e.g., respiratory failure, decreased airway protection) within 72 hours after extubation.
|
- Up to 72 hours post-extubation
|
|
- Rescue NIV/HFNC within 48 or 72 hours post-extubation
大体时间：- Up to 48 hours or 72 hours post-extubation
|
- Proportion of patients requiring urgent initiation of non-invasive ventilation (NIV) or high-flow nasal cannula (HFNC) due to respiratory distress or hypoxemia within 48 or 72 hours after extubation.
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- Up to 48 hours or 72 hours post-extubation
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|
- Ventilator-free days at 28 days (D28)
大体时间：- Up to 28 days post-enrollment
|
- The number of days from the first successful weaning and extubation until day 28, during which the patient is alive and free from invasive mechanical ventilation.
If the patient dies or remains on mechanical ventilation for more than 28 days, it is recorded as 0 days.
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- Up to 28 days post-enrollment
|
|
- Length of stay in the ICU and hospital
大体时间：From the date of randomization until the date of ICU discharge or hospital discharge, whichever came first, assessed up to 12 months.
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- The number of days from enrollment (day of first SBT) to ICU discharge, and from enrollment to final hospital discharge.
|
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
大体时间：From the date of randomization until the date of ICU discharge or death, whichever came first, assessed up to 12 months.
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- The proportion of patients who die during their ICU stay and during the entire hospital stay (until discharge).
|
From the date of randomization until the date of ICU discharge or death, whichever came first, assessed up to 12 months.
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- Correlation between RDSI and conventional respiratory mechanics/diaphragm ultrasound parameters
大体时间：At the end of the first PSV-SBT (approximately 30 to 120 minutes post-initiation)
|
- Assessment of the statistical correlation between the novel RDSI index and conventional weaning predictors, including Rapid Shallow Breathing Index (RSBI), Maximum Inspiratory Pressure (MIP/NIF), Vital Capacity (VC), Cough Peak Flow (CPF), Airway Occlusion Pressure (P0.1),
Diaphragmatic Excursion (DE), and Diaphragm Thickening Fraction (DTF).
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At the end of the first PSV-SBT (approximately 30 to 120 minutes post-initiation)
|
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- Feasibility and reliability of RDSI image acquisition and speckle tracking
大体时间：At the end of the first PSV-SBT, up to 120 minutes post-initiation (upon image completion)
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- Assessment of the acquisition rate of diaphragm ultrasound images, the analyzability rate (proportion of successful speckle tracking analysis), and the inter-observer and intra-observer measurement agreement (Intraclass Correlation Coefficient, ICC).
|
At the end of the first PSV-SBT, up to 120 minutes post-initiation (upon image completion)
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
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.
- Mahmoodpoor A, Fouladi S, Ramouz A, Shadvar K, Ostadi Z, Soleimanpour H. Diaphragm ultrasound to predict weaning outcome: systematic review and meta-analysis. Anaesthesiol Intensive Ther. 2022;54(2):164-174. doi: 10.5114/ait.2022.117273.
- Parada-Gereda HM, Tibaduiza AL, Rico-Mendoza A, Molano-Franco D, Nieto VH, Arias-Ortiz WA, Perez-Teran P, Masclans JR. Effectiveness of diaphragmatic ultrasound as a predictor of successful weaning from mechanical ventilation: a systematic review and meta-analysis. Crit Care. 2023 May 5;27(1):174. doi: 10.1186/s13054-023-04430-9.
- Park JE, Kim DY, Park JW, Jung YJ, Lee KS, Park JH, Sheen SS, Park KJ, Sunwoo MH, Chung WY. Development of a Machine Learning Model for Predicting Weaning Outcomes Based Solely on Continuous Ventilator Parameters during Spontaneous Breathing Trials. Bioengineering (Basel). 2023 Oct 5;10(10):1163. doi: 10.3390/bioengineering10101163.
- Thille AW, Gacouin A, Coudroy R, Ehrmann S, Quenot JP, Nay MA, Guitton C, Contou D, Labro G, Reignier J, Pradel G, Beduneau G, Dangers L, Saccheri C, Prat G, Lacave G, Sedillot N, Terzi N, La Combe B, Mira JP, Romen A, Azais MA, Rouze A, Devaquet J, Delbove A, Dres M, Bourenne J, Lautrette A, de Keizer J, Ragot S, Frat JP; REVA Research Network. Spontaneous-Breathing Trials with Pressure-Support Ventilation or a T-Piece. N Engl J Med. 2022 Nov 17;387(20):1843-1854. doi: 10.1056/NEJMoa2209041. Epub 2022 Oct 26.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年8月23日
初级完成 (估计的)
2027年8月21日
研究完成 (估计的)
2027年8月30日
研究注册日期
首次提交
2026年7月5日
首先提交符合 QC 标准的
2026年7月23日
首次发布 (实际的)
2026年7月29日
研究记录更新
最后更新发布 (实际的)
2026年7月29日
上次提交的符合 QC 标准的更新
2026年7月23日
最后验证
2026年7月1日
更多信息
与本研究相关的术语
其他研究编号
- 20260625
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