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临床试验/NCT04524091
NCT04524091招募中不适用

Prediction of Inspiratory Effort Response to High PEEP in Patients Recovering From ARDS

Sanatorio Anchorena San Martin2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年8月1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
30
试验地点
2
主要终点
Inspiratory ratio

研究概览

简要总结

Spontaneous breathing during the transition from controlled to assisted ventilation in ARDS may be harmful, as high respiratory drive can generate large transpulmonary pressure swings and worsen lung injury. Higher PEEP may mitigate this by reducing inspiratory effort and lung stress, but patient response is variable and difficult to predict. While improved lung compliance appears to mediate the protective effects of PEEP, its bedside assessment is complex. Preclinical data suggest that changes in compliance are inversely reflected by changes in respiratory rate, but this relationship and its clinical utility in ARDS patients remain unclear.

详细描述

Spontaneous Breathing (SB) can be potentially harmful in patient with Acute Respiratory Distress Syndrome (ARDS) during the transition phase of passive ventilation to partial ventilatory support. A high respiratory drive and consequently, a strong inspiratory effort, may produce large transpulmonary pressure (TP) swings mainly in dependent lung regions closer to the diaphragm and cause alveolar rupture and inflammatory mediators release.

The application of high Positive End Expiratory Pressure (PEEP) during SB has shown to ameliorate the progression of lung injury by decreasing the TP and esophageal pressure (EP) swings and the stress / strain applied to the lung. However, it is uncertain which patient will respond adequately to the application of high PEEP and consequently will reduce the inspiratory effort.

Recent evidence suggests that high PEEP may confer protective effects when lung compliance improves. However, assessing lung compliance at the bedside is challenging, as it requires esophageal pressure monitoring. Simpler tools to identify lung compliance response to PEEP are neccesary.

Preclinical data suggest that the changes in compliance are followed by opposite changes in respiratory rate (RR) - i.e., if compliance improves, RR decreases and vicerversa. However, if this behaviour is also observed in ARDS patients ventilated at different PEEP levels is unkown. Additionally, whether changes in RR can be useful to identify changes in lung compliance when increasing PEEP has never been tested.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Need of invasive mechanical ventilation
  • Patients who had fulfill ARDS criteria based on Berlin definition during any time of invasive mechanical ventilation.
  • Patient ventilated in pressure support ventilation.
  • Time of invasive ventilation expected to be longer than 24 hs after the day of enrollment.

排除标准

  • Neuromuscular diseases (e.g., amyotrophic lateral sclerosis, Duchenne Erb)
  • previous diagnosis of chronic obstructed pulmonary disease
  • not resolved pneumothorax
  • bronchopleural fistula
  • suspicion of central respiratory drive alteration (e.g., benzodiazepines intoxication).

结局指标

主要结局

Inspiratory ratio

时间窗: 10 minutes

Inspiratory ratio will be calculated using the formula (IPSexp - IPSinsp )/IPSexp x 100, being IPSexp = negative deflection in airway pressure during an end expiratory pause; IPSinsp = negative deflection in airway pressure during an end inspiratory pause.

Lung compliance response

时间窗: 10 minutes

changes in lung compliance from one PEEP level to the subsequent higher level, expressed in percentage of change

次要结局

  • Esophageal pressure swing(10 minutes)
  • Dynamic transpulmonary pressure swing(10 minutes)
  • Respiratory rate response(10 minutes)

研究者

发起方
Sanatorio Anchorena San Martin
申办方类型
Other
责任方
Principal Investigator
主要研究者

Matias Accoce

Head of physica therapy department

Sanatorio Anchorena San Martin

研究点 (2)

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