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Computed Inspiratory Muscle Pressure to Monitor Inspiratory Effort During Pressure Support Ventilation

2026年11月6日 更新者:Jian-Xin Zhou

Validation of Computed Inspiratory Muscle Pressure to Monitor Inspiratory Effort During Pressure Support Ventilation: A Prospective Physiological Study

The goal of this study is to validate computed inspiratory muscle pressure (cPmus) for monitoring inspiratory effort in adults receiving pressure support ventilation. Researchers will compare cPmus with reference inspiratory muscle pressure calculated using an esophageal balloon catheter, a thin pressure-measuring tube placed in the esophagus. The study will look at how closely the two methods are related and whether they give similar results. Participants will undergo simultaneous monitoring with cPmus and an esophageal balloon catheter. Researchers will adjust pressure support across six levels, recording measurements from both methods at each level.

研究概览

详细说明

This is a prospective validation study with repeated measurements. It aims to validate computed inspiratory muscle pressure (cPmus), a noninvasive estimate of inspiratory muscle pressure provided by the study ventilator (Prunus Padus 9, Shenzhen, China). The reference method is esophageal pressure-derived inspiratory muscle pressure (Pmus). The study will enroll adults receiving invasive pressure support ventilation (PSV).

After obtaining informed consent, participants will undergo simultaneous monitoring with the cPmus algorithm and an esophageal balloon catheter. Pressure support will be adjusted in six levels. Positive end-expiratory pressure (PEEP) will remain unchanged. Each pressure support level will be maintained for 10 minutes. Brief end-expiratory and end-inspiratory occlusion maneuvers will also be performed at each level to obtain additional indices of respiratory drive and inspiratory effort. Esophageal balloon will be removed after completing the last pressure support step.

At each pressure support level, paired values of cPmus and reference Pmus were measured. The corresponding inspiratory pressure-time products, cPTPmus and PTPmus, will also be calculated.

All procedures will follow the study protocol and standardized measurement procedures. Study data will be recorded in case report forms and an electronic database, with checks for completeness, accuracy, and waveform quality.

研究类型

介入性

注册 (估计的)

30

阶段

  • 不适用

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

研究联系人备份

学习地点

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

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. Age 18 years or older.
  2. Receiving pressure support ventilation.
  3. Written informed consent provided by the participant or a legally authorized representative.

Exclusion Criteria:

  1. Contraindication to esophageal catheter placement, including uncontrolled coagulopathy, skull base fracture, upper gastrointestinal bleeding, tumor or surgery, neck surgery, or esophagogastric varices.
  2. Chest trauma, a postoperative state following lung surgery, an active pulmonary air leak (pneumothorax, pneumomediastinum, or bronchopleural fistula), or an indwelling chest drain.
  3. Neuromuscular disease, diaphragmatic dysfunction, or diaphragmatic surgery.
  4. Impaired central respiratory drive due to intracranial hypertension or brainstem injury.
  5. Hemodynamic instability, defined as mean arterial pressure <60 mmHg, systolic blood pressure >180 mmHg, heart rate <40 or >150 beats/min, or norepinephrine dose >1 mcg/kg/min.
  6. Pregnancy or breastfeeding.
  7. A decision to withdraw life-sustaining treatment or provide palliative care.

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

  • 主要用途:诊断
  • 分配:随机化
  • 介入模型:交叉作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Pressure support 15

Pressure support of 15 cm H2O will be applied for 10 minutes.

Pressure support of 15 cm H2O will be applied for 10 minutes.

实验性的:Pressure support 13

Pressure support of 13 cm H2O will be applied for 10 minutes.

Pressure support of 13 cm H2O will be applied for 10 minutes.

实验性的:Pressure support 11

Pressure support of 11 cm H2O will be applied for 10 minutes.

Pressure support of 11 cm H2O will be applied for 10 minutes.

实验性的:Pressure support 9

Pressure support of 9 cm H2O will be applied for 10 minutes.

Pressure support of 9 cm H2O will be applied for 10 minutes.

实验性的:Pressure support 7

Pressure support of 7 cm H2O will be applied for 10 minutes.

Pressure support of 7 cm H2O will be applied for 10 minutes.

实验性的:Pressure support 5

Pressure support of 5 cm H2O will be applied for 10 minutes.

Pressure support of 5 cm H2O will be applied for 10 minutes.

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
Computed inspiratory muscle pressure (cPmus)
大体时间:2 hours

Computed inspiratory muscle pressure (cPmus) will be measured.

2 hours
Inspiratory muscle pressure (Pmus)
大体时间:2 hours

Inspiratory muscle pressure (Pmus) will be measured.

2 hours
Computed inspiratory muscle pressure-time product (cPTPmus)
大体时间:2 hours

Computed inspiratory muscle pressure-time product (cPTPmus) will be measured.

2 hours
Inspiratory muscle pressure-time product (PTPmus)
大体时间:2 hours

Inspiratory muscle pressure-time product (PTPmus) will be measured.

2 hours

次要结果测量

结果测量
措施说明
大体时间
Occluded airway pressure at 100ms (P0.1)
大体时间:2 hours

Occluded airway pressure at 100ms (P0.1) will be measured.

2 hours
Maximal decrease of airway pressure during end-expiratory occlusion (∆Pocc)
大体时间:2 hours

Maximal decrease of airway pressure during end-expiratory occlusion (∆Pocc) will be measured.

2 hours
Pressure muscle index (PMI)
大体时间:2 hours

Pressure muscle index (PMI) will be measured.

2 hours

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

调查人员

  • 首席研究员:Jian-Xin Zhou、Capital Medical University

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10月22日

初级完成 (估计的)

2027年4月30日

研究完成 (估计的)

2027年4月30日

研究注册日期

首次提交

2026年10月15日

首先提交符合 QC 标准的

2026年10月15日

首次发布 (实际的)

2026年10月21日

研究记录更新

最后更新发布 (实际的)

2026年11月9日

上次提交的符合 QC 标准的更新

2026年11月6日

最后验证

2026年11月1日

更多信息

与本研究相关的术语

其他研究编号

  • IIT2026-032-002

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.

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