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临床试验/NCT05990348
NCT05990348招募中不适用

Estimation of the Diaphragm Electrical Activity and Intercostal Thickening Fraction During Different Pattern of Mechanical Ventilation: PSV Versus NAVA

Fondazione Policlinico Universitario Agostino Gemelli IRCCS1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
20
试验地点
1
主要终点
intercostal thickening fraction

研究概览

简要总结

the introduction of new MV modalities has shown promising results in reducing the incidence of weaning failure, mainly due to a more physiologic approach which allows respiratory muscle preservation. Among them, the Neurally Adjust Ventilatory Assist (NAVA) seemed to be associated with lower incidence of weaning failure and subsequent duration of mechanical ventilation, compared to standard modalities like the Pressure Support Ventilation (PSV) . Moreover, NAVA allows the evaluation of the diaphragm electrical activity (EAdi), an index of diaphragmatic neural respiratory drive. However, no study has compared TFic values during PSV and NAVA modalities in patients with difficult weaning from MV admitted in ICU.

详细描述

Respiratory muscles dysfunction is one of the main causes leading to failure of weaning from mechanical ventilation (MV) in critically ill patients. Muscular activity is important during the inspiratory phase of ventilation, which is mainly due to diaphragm and external intercostal muscles. Diaphragm dysfunction is frequent among critically ill patients and ranges from 33 to 95% . Although several indexes have been investigated to help clinician in identifying its disturbance, their clinical value is controversial . External intercostal muscles dysfunction epidemiology is unknown because of lack of non-invasive tool to investigate such condition. However, the echography assessment of intercostal muscles thickening fraction (TFic) has shown promising results in this field as a non-invasive tool to assess inspiratory muscle function and predict weaning failure .

On the other hand, the introduction of new MV modalities has shown promising results in reducing the incidence of weaning failure, mainly due to a more physiologic approach which allows respiratory muscle preservation. Among them, the Neurally Adjust Ventilatory Assist (NAVA) seemed to be associated with lower incidence of weaning failure and subsequent duration of mechanical ventilation, compared to standard modalities like the Pressure Support Ventilation (PSV) [. Moreover, NAVA allows the evaluation of the diaphragm electrical activity (EAdi), an index of diaphragmatic neural respiratory drive . A recent study suggests that EAdi and derived parameters, may be helpful to predict weaning failure in chronic obstructive pulmonary disease (COPD) patients .

However, no study has compared TFic values during PSV and NAVA modalities in patients with difficult weaning from MV admitted in ICU.

the aim of this study will be the comparison of TFic values during PSV and NAVA modalities in patients with difficult weaning from MV admitted in ICU and the assessment of the inspiratory effort parameters and the occurrence of respiratory asynchrony in patients with difficult weaning from MV admitted in ICU.

研究设计

研究类型
Observational
观察模型
Case Crossover
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

  • patients who have failed at least one weaning attempt
  • mechanical ventilation for at least 24 hours

排除标准

  • Pregnancy
  • Obesity (Body Mass Index > 35 kg/m2)
  • Contraindication to the insert of a nasogastric tube
  • Neuromuscular diseases

结局指标

主要结局

intercostal thickening fraction

时间窗: From date of enrollment until the date of extubation (up to seven days)

intercostal thickening fraction values during PSV and NAVA

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

SPINAZZOLA GIORGIA

Medical Doctor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

研究点 (1)

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