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临床试验/NCT05125744
NCT05125744Unknown不适用

Effect of Positive End Expiratory Pressure on Respiratory Muscles Activity Assessed Through Ultrasound in Intubated Patient Undergoing Assisted Ventilation

Azienda Ospedaliera di Perugia1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年3月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
30
试验地点
1
主要终点
Diaphragmatic thickening fraction

研究概览

简要总结

The investigators aim to assess the effects of positive end-expiratory pressure (PEEP) on diaphragmatic activity evaluated through ultrasound in patients admitted to intensive care unit (ICU) for acute respiratory failure (ARF) assisted via invasive mechanical ventilation in assisted mode.

详细描述

All adult critically ill patients admitted to intensive care unit (ICU) and undergoing invasive mechanical ventilation (IMV) for more than 24 hours with diagnosis of acute respiratory failure (ARF) will be screened.

The exclusion criteria will be : pregnancy, neuromuscular diseases, wounds or incision at the probe placement site, contraindications to diaphragmatic and abdominal wall unltrasound, contraindications to the placement of a specific nasogastric feeding tube (Electrical activity of the diaphragm catheter).

In all enrolled patients ventilated in assisted mode, diaphragmatic activity will be evaluated through ultrasound and electrical activity of the diaphragm (primary end point) at stepwise decreasing of PEEP level. Also, the activity of remaining respiratory muscles will be assessed through sonography at the same levels of PEEP (secondary end point) Across all study phases, patients will be sedated to assure a Richmond sedation Agitation Scale (RASS) score between 0 and -1.

The following data will be recorded for each positive end-expiratory pressure explored: dosage of sedative drugs, peripheral oxygen saturation (SpO2), inspired oxygen fraction (FiO2), inpiratory and expiratory tidal volume, respiratory rate, electrical activity of the diaphragm (Eadi) (optional data), lung aeration through ultrasound or electrical impedance tomography (optional), thickness of diaphragmatic, parasternal intercostal, external oblique, internal oblique and transversus abdominis, combined with the lung ultrasound score. Thickness is measured at both end-expiration and end-inspiration for each respiratory muscles, as indirect estimation of respiratory muscles effort, and calculated according to standard formula as follows: Thickening fraction (%) = (inspiratory thickness - expiratory thickness) / expiratory thickness * 100. All ultrasonographic measurements will be performed bedside with patients in semi-recument position, only on the right side , using a portable ultrasound machine equipped with a linear (7.5 - 12.0 MHz) or convex (2.0 - 4.0 MHz) probe. The same protocol will be carried out in case of non invasive ventilation application after extubation, reducing PEEP and inspiratory support

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 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age > 18 years
  • invasive mechanical ventilation > 48 hours

排除标准

  • pregnancy
  • neuromuscular disease
  • wounds or incision at the probe placement site.

结局指标

主要结局

Diaphragmatic thickening fraction

时间窗: 20 minutes

The fraction of diaphragmatic thickness variations expressed in percentage during a stepwise decrease in positive end-expiratory pressure (PEEP)

次要结局

  • Lung aeration(20 minutes)
  • Respiratory rate(20 minutes)
  • Electrical activity of the diaphragm (optional)(20 minutes)
  • Inspired oxygen fraction(20 minutes)
  • Peripheral oxygen saturation(20 minutes)
  • Expiratory Tidal volume(20 minutes)
  • Accessory respiratory muscles thickening fraction(20 minutes)

研究者

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

Prof Gianmaria Cammarota

Clinical Prophessor

Azienda Ospedaliera di Perugia

研究点 (1)

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