跳至主要内容
临床试验/NCT05950893
NCT05950893招募中不适用

The Clinical Feasibility and Validity of Simple Measurement of Inspiratory Muscle Pressure Index (PMIvent) to Access Inspiratory Effort During Pressure Support Ventilation

Jian-Xin Zhou1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2023年3月25日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
25
试验地点
1
主要终点
Agreement of PMIvent and PMIref

研究概览

简要总结

It is critical to maintain a relatively normal inspiratory effort during pressure support ventilation (PSV), the support level should be adjusted to match the patient's inspiratory effort. The inspiratory muscle pressure index (PMI) can reflect the elastic work of the respiratory system at the end of inspiration and has a significant correlation with inspiratory effort, and it has the outgoing advantages of being non-invasive and easy to obtain. Previous studies on PMI were based on physiological research and experimental conditions (PMIref), which require special pressure monitoring devices and software to collect and measure airway pressure. If PMI is going to be used in clinical practice, it is necessary to find a simple measurement method of PMI to replace PMIref. Most ventilators have airway pressure monitoring and end-inspiratory holding functions, and PMI can be measured by freezing the ventilator screen (PMIvent). The overall aim of this study was to determine PMIvent's clinical feasibility and validity for accessing inspiratory effort during PSV.

详细描述

The intensity of effort the respiratory system produces after receiving respiratory center drive is referred to as inspiratory effort. It is critical to maintain a relatively normal inspiratory effort during assist mechanical ventilation. During pressure support ventilation (PSV), the support level should be adjusted to match the patient's inspiratory effort.

The inspiratory muscle pressure index (PMI) is an indicator based on airway pressure (Paw), defined as the difference between plateau pressure (Pplat) and airway peak pressure (Ppeak). PMI can reflect the elastic work of the respiratory system at the end of inspiration and has a significant correlation with end-inspiratory muscle pressure (Pmus,ei) and esophageal pressure time product per breath (PTPes). Current studies have shown that PMI is an accurate indicator of inspiratory effort, and it has the outgoing advantages of being non-invasive and easy to obtain.

Previous studies on PMI were based on physiological research and experimental conditions, which require special pressure monitoring devices and software to collect and measure airway pressure. In this investigation, the standard measurement of PMI (PMIref) was the difference between Pplat at one cardiac cycle (0.5-1.2s) following end-inspiratory occlusion (EIO) and Ppeak at EIO. This measurement method can avoid the interference of cardiac artifacts on Paw to the greatest extent. If PMI is going to be used in clinical practice, it is necessary to find a simple measurement method of PMI to replace PMIref. Most ventilators have airway pressure monitoring and end-inspiratory holding functions, and PMI can be measured by freezing the ventilator screen (PMIvent). When obtaining PMIvent, the operator could only select a relatively stationary Pplat by visual inspection, and the cardiac artifacts could not be avoided.

Several additional issues need to be addressed when PMI is going to be used in clinical practice to monitor inspiratory effort in ventilated patients. Is PMI easy to obtain? Can PMIvent replace PMIref? What is the effect of different ventilators on PMIvent measurement? What is the relationship between PMIvent and inspiratory effort? Can PMIvent detect high/low effort? Therefore, the aims of this study were to explore the clinical acquisition rate of PMI, the agreement between PMIvent and PMIref, and the predicted value of PMIvent for inspiratory effort. The overall aim was to determine PMI's clinical feasibility and validity for accessing inspiratory effort during PSV.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult acute respiratory failure patients undergoing mechanical ventilation were screened daily and enrolled 24 hours after switching to PSV mode

排除标准

  • age younger than 18 years old or older than 85 years
  • known pregnancy and parturient
  • chronic occlusive pulmonary diseases
  • gastric, esophageal injury
  • diaphragm dysfunction
  • intracranial hypertension and brain stem injury
  • consciousness level decreased (RASS less than -2 scores)
  • Anticipating withdrawal of life support and/or shift to palliation as the goal of care.

结局指标

主要结局

Agreement of PMIvent and PMIref

时间窗: 3 hours

The accuracy of PMIvent compared to PMIref was assessed by a Bland-Altman plot for each ventilator.

次要结局

  • Correlation of inspiratory effort and PMIvent(3 hours)
  • The predicted value of PMIvent for low/high effort(3 hours)

研究者

发起方
Jian-Xin Zhou
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Jian-Xin Zhou

Professor

Capital Medical University

研究点 (1)

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