此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

Advanced Respiratory Monitoring for Safer Mechanical Ventilation in Patients Without Respiratory Failure (ADAPT)

2026年6月30日 更新者：Michele Tedeschi、Istituto Clinico Humanitas
Patients admitted to the intensive care unit (ICU) and mechanically ventilated for reasons other than acute respiratory failure, such as coma, trauma, or sepsis, are at risk of developing acute respiratory distress syndrome (ARDS), which increases the duration of mechanical ventilation, mortality, and functional dependence at discharge.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

Patients admitted to the intensive care unit (ICU) and mechanically ventilated for reasons other than acute respiratory failure, such as coma, trauma, or sepsis, are at risk of developing acute respiratory distress syndrome (ARDS), which increases the duration of mechanical ventilation, mortality, and functional dependence at discharge. Low tidal volume mechanical ventilation is recommended for these patients to prevent ARDS, but few other modifiable risk factors are known. Advanced respiratory monitoring, which includes continuous recording of airway and esophageal pressure, inspiratory and expiratory flow, and the distribution of ventilation within the lungs, has been used in patients with ARDS to personalize ventilation parameters, prevent ventilator-induced lung injury (VILI), and improve outcomes. It is unknown whether the use of these same monitoring techniques in patients without respiratory failure at the time of ICU admission can prevent the development of ARDS.

研究类型

观察性的

注册 (估计的)

40

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。

学习地点

  • 意大利
    • Lombardy
      • Milan、Lombardy、意大利、20089
        • 招聘中
        • Humanitas Research Hospital
        • 接触：
          • Giulia Lionetti GL Medical Doctor and Anesthesiologist, Medicine and Anesthesiology
          • 电话号码：0282243789
          • 邮箱：giulia.lionetti@humanitas.it
        • 接触：
          • Alessandro Santini AS Medical Doctor and Anesthesiologist, Medicine and Anesthesiology
          • 电话号码：0282243789
          • 邮箱：alessandri.santini@humanitas.it

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

非概率样本

研究人群

The study population consists of adult patients admitted to the Intensive Care Unit (ICU) who require invasive mechanical ventilation for reasons entirely distinct from acute respiratory failure, such as coma, trauma, or sepsis. Eligible individuals must be enrolled and have monitoring initiated within the first 24 hours of oro-tracheal intubation. The cohort excludes patients with specific barotrauma complications, pregnant individuals, and those with absolute clinical contraindications to the required monitoring procedures.

描述

Study Population Eligibility Ages Eligible for Study: 18 Years and older (Adult, Older Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: No

Inclusion Criteria:

Adult patients +18 years. Undergoing invasive mechanical ventilation for reasons other than acute respiratory failure (such as coma, trauma, or sepsis).

Initiation of monitoring within 24 hours of oro-tracheal intubation.

Exclusion Criteria:

Evidence of pneumothorax, pneumomediastinum, or subcutaneous emphysema. Pregnancy. Absolute contraindications to nasogastric tube placement. Absolute contraindications to electrical impedance tomography (EIT) monitoring.

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 without acute respiratory failure undergoing mechanical ventilation.
诊断测试：Advanced Non-Invasive Respiratory Monitoring
Continuous measurement and recording of airway pressure, esophageal pressure, inspiratory and expiratory flow, and electrical impedance tomography (EIT) data during the first 24 hours of mechanical ventilation. A nasogastric tube equipped with an esophageal balloon is placed alongside an EIT electrode belt. Monitoring is performed continuously off-line without altering standard clinical management. Residual respiratory function is also evaluated via spirometry and EIT prior to Intensive Care Unit (ICU) discharge.

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
Incidence of Acute Respiratory Distress Syndrome (ARDS)
大体时间：Within the first 7 days of Intensive Care Unit (ICU) admission.

Association between ARDS development and advanced respiratory monitoring parameters derived from:

Airway pressure/flow analysis: tidal volume/kg of ideal body weight, respiratory rate, plateau pressure, driving pressure, respiratory system compliance, and stress index.

Esophageal pressure analysis: lung compliance, transpulmonary plateau pressure, transpulmonary driving pressure, and chest wall compliance.

Electrical impedance tomography (EIT): regional compliance and tidal volume distribution homogeneity.
Within the first 7 days of Intensive Care Unit (ICU) admission.

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

Istituto Clinico Humanitas

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6月30日

初级完成 (估计的)

2026年12月30日

研究完成 (估计的)

2026年12月30日

研究注册日期

首次提交

2026年6月30日

首先提交符合 QC 标准的

2026年6月30日

首次发布 (实际的)

2026年7月7日

研究记录更新

最后更新发布 (实际的)

2026年7月7日

上次提交的符合 QC 标准的更新

2026年6月30日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • ADAPT

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

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.

订阅