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Patient-Ventilator Asynchrony: Occurence and Clinical Impact in Usual Care (PVA-detection)

2026年8月11日 更新者：Annemijn Jonkman、Erasmus Medical Center

Unraveling the Clinical Impact of Patient-Ventilator Asynchrony in Usual Care

The goal of this observational study is to unravel the occurence, impact and relations of Patient-Ventilator Aynchrony (PVA) in mechanically ventilated patients. The main questions it aims to answer are:

  • How often does PVA occur?
  • What are relations between clinical characteristics and PVA occurence?
  • What are relations between PVA occurence and patient outcomes?

All questions will be assessed using data collected during the whole course of mechanical ventilation. Mechanically ventilated patients' medical data will be re-used. PVAs will be automatically classified on ventilator waveform data, using validated Deep Breath software.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

Many ventilated patients show excessive breathing efforts and abnormal, irregular breathing. This patient-ventilator asynchrony (PVA) is associated with serious discomfort, lung injury, sleep disruption and higher mortality. PVA exists in many forms and is reported in 10-90% of patients, but identifying and resolving it is challenging, even for expert clinicians. Hence, PVA prevalence and impact is likely highly underestimated, and the direct causal link with worse outcomes is inconclusive. PVAs should be better dettected, understood and resovled to optimize the individual patient's treatment.

In a previous study, the investigators validated an AI-based algorithm capable of reliable PVA detection (Deep Breath software). In this study, the investigators will apply this algorithm to the collected ventilator waveform data (offline processing), in order to reliably assess PVA occurrence, and its relation with clinical outcomes and patient characteristics in current clinical care. Data of minimally 110 patients collected over the whole course of mechanical ventilation will be assessed. Patients will be included in three ICUs to promote generalizability.

The primary outcome will be the asynchrony index (in total and per PVA type) over time. Secondary outcomes will include, but are not limited to: clinical characteristics (e.g. respiratory and hemodynamic parameters, sedation), (ICU) mortality, ventilator free days at day 28 and 90, duration of ventilation, weaning success and reintubation rate.

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

学习地点

  • 荷兰
    • North Brabant
      • Eindhoven、North Brabant、荷兰、5623EJ
        • 招聘中
        • Catharina Ziekenhuis Eindhoven (CZE)
        • 接触：
        • 首席研究员：
          • Ashley de Bie, PhD
        • 副研究员：
          • Thijs Rietveld, MSc
    • South Holland
      • Leiden、South Holland、荷兰、2333ZA
        • 尚未招聘
        • Leiden University Medical Center (LUMC)
        • 副研究员：
          • Thijs Rietveld, MSc
        • 接触：
        • 首席研究员：
          • Bram Schoe, PhD
      • Rotterdam、South Holland、荷兰、3015GD
        • 招聘中
        • Erasmus Medical Center (EMC)
        • 接触：
        • 首席研究员：
          • Annemijn Jonkman, PhD
        • 副研究员：
          • Thijs P Rietveld, MSc

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

Adult patients admitted to the ICU that receive invasive mechanical ventilation.

描述

Inclusion Criteria:

  • Age > 18 years old.
  • Recordings available of ventilator waveforms synchronized with the patient's electronic health record during invasive mechanical ventilation.
  • Duration of mechanical ventilation of at least 24 hours.

Exclusion Criteria:

  • (Previous) registered objection of patient and/or relatives to re-use clinical data for research purposes
  • No consent for re-use of data for research

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
Adult patients admitted to the ICU that receive invasive mechanical ventilation
Patients need to be >18 years old, receive mechanical ventilation for at least 24 hours and have recordings available of ventilator waveforms, synchronized with the patient's electronic health record, during invasive mechanical ventilation.
其他：PVA classification software
Patients will receive standard care, without an intervention. Data will be captured as part of standard care and analyzed for PVAs retrospectively, using dedicated offline software.

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
Asynchrony index over time (aggregated and per PVA type)
大体时间：28 days
Measure of how much asynchrony occurs and at what time. This measure will be calculated for all PVA types together, as well as per PVA type. The investigators calculate this over time, to see when asynchrony occurs, as well as in total, to get a global PVA prevalence measure (over the whole duration of ventilation).
28 days

次要结果测量

结果测量
措施说明
大体时间
第 28 天的死亡率
大体时间：28天
第 28 天的死亡率
28天
Use of sedatives (cumulative dose and type)
大体时间：28 days
28 days
Mechanical ventilation settings
大体时间：28 days
28 days
Respiratory parameters
大体时间：28 days
28 days
Hemodynamic parameters
大体时间：28 days
28 days
Relevant medication
大体时间：28 days
e.g. vasoactive agents, delirium related medication, analgesics
28 days
Use of assist devices
大体时间：28 days
e.g. dialysis, pacemaker, ventricular assist device, ECMO
28 days
Gas exchange parameters
大体时间：28 days
e.g. P/F ratio, PaO2, PaCO2, pH, bicarbonate
28 days
Blood inflammatory biomarkers
大体时间：28 days
upon availability in the patient's electronic chart, e.g. CRP, lactate
28 days
Sedation depth
大体时间：28 days
Richmond Agitation-Sedation Scale (RASS-score). This score ranges from -5 to +4, where a more positive score indicates more agitation.
28 days
Reported delirium
大体时间：28 days
Reported delirium, observed via the Delirium Observation Screening (DOS), or the Intensive Care Delirium Screening Checklist (ICDSC), depending on the standard of care of the participating center. The DOS ranges from 0-13, with a score ≥3 indicating delirium. The ICDSC ranges from 0-8, with 0-3 indicating absence of delirium and a score of ≥4 inidicating delirium.
28 days
Illness severity score (SOFA-score)
大体时间：28 days
SOFA-score. This score ranges from 0-24, with increasing scores reflecting more abnormal physiology and biochemistry or an increasing degree of intervention.
28 days
ICU mortality
大体时间：90 days
Mortality during ICU stay
90 days
Mortality at day 90
大体时间：90 days
Mortality at day 90
90 days
Duration of ventilation
大体时间：28 days
Duration of ventilation in hours or days
28 days
Ventilator free days (at day 28)
大体时间：28 days
Number of ventilator free days at day 28
28 days
Ventilator free days (at day 90)
大体时间：90 days
Number of ventilator free days at day 90
90 days
Reintubation rate
大体时间：28 days
Number of times reintubation occured, reported as % of patients needing reintubation.
28 days
Weaning success
大体时间：28 days
Weaning success rate (%), defined as seven consecutive days without ventilator support
28 days
ICU length of stay
大体时间：28 days
Length of ICU stay, measured in days
28 days
Complications
大体时间：28 days
Complications (e.g. ventilator associated pneumonia and ICU acquired weakness) as reported in the patient file.
28 days

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。

赞助

Erasmus Medical Center

合作者

Catharina Ziekenhuis Eindhoven
Leiden University Medical Center
Deep Breath

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。

有用的网址

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 (实际的)

2026年7月21日

初级完成 (估计的)

2026年11月1日

研究完成 (估计的)

2027年2月1日

研究注册日期

首次提交

2026年5月13日

首先提交符合 QC 标准的

2026年5月29日

首次发布 (实际的)

2026年6月3日

研究记录更新

最后更新发布 (实际的)

2026年8月13日

上次提交的符合 QC 标准的更新

2026年8月11日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • MEC-2025-0353
  • EMCLSH24018 (其他赠款/资助编号：Health~Holland)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

The final dataset will be available on reasonable request, with removed/anonymized timestamps for pseudonimization. The request will be reviewed by the PI, depending on the topic/quality of the proposal and including a plan for publication/authorship, and ensuring that the request meets legal and organizational requirements. Sharing of data for reuse by third parties will always only involve de-identified datasets and via a data transfer agreement.

IPD 共享时间框架

IPD will be available after publication of the Clinical Study Report. IPD will be available for 10 years, in compliance with Dutch laws.

IPD 共享支持信息类型

  • 研究方案
  • 分析代码
  • 企业社会责任

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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.

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