跳至主要内容
临床试验/NCT04503876
NCT04503876Unknown不适用

Pulmonary and Ventilatory Effects of End-expiratory Positive Pressure Optimization in Intubated ICU Patients With Healthy Lungs or Acute Respiratory Distress Syndrome. A Randomized Controlled Trial

University Hospital, Clermont-Ferrand1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2019年9月12日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
45
试验地点
1
主要终点
Recruited lung volume at each PEEP level between the 2 strategies (incremental or decremental).

研究概览

简要总结

PEEP titration is a recommended during invasive mechanical ventilation of ICU patients. However, little is known about the right way to conduct this titration. PEEP titration can be conducted by a stepwise increase in PEEP level, or following an ARM and a consecutive stepwise decrease in PEEP level. Those 2 methods will be explored in intubated ICU patients either with healthy lung or ARDS lungs. Physiological exploration will include end-expiratory lung volume measurements, driving pressure, compliance and electro-impedance tomography at each PEEP level.

详细描述

Management of ICU patients may require the use of ventilatory support requiring tracheal intubation and invasive mechanical ventilation.

Any mechanically ventilated patient is exposed to the formation of atelectasis (collapsed pulmonary alveoli), which occurs systematically after endotracheal tube insertion, after any de-recruiting action (tracheal suction, disconnection) or simply if protective ventilation is used, combining small tidal volumes (6 to 8 mL/kg of theoretical ideal body weight - IBW) and an end-expiratory positive pressure (PEEP) that is sometimes insufficient. It is thus proposed to perform alveolar recruitment maneuvers (ARMs), which remove atelectasis by temporarily increasing intrathoracic pressure. To avoid alveolar re-collapse, it is necessary to apply a sufficient level of PEEP.

The opening pressure (P) necessary for the re-expansion of a collapsed alveolus is inversely proportional to its radius (r), following Laplace law P = 2.γ/r where γ is the surface tension. The pressure necessary to the re-expansion of a collapsed cell depends on its radius. Amato's team has showed in 2006 that within the same lung, several levels of alveolar aeration and thus several opening pressures coexist. The distribution of pressures was bimodal, with a peak around 30 cmH2O and a second around 40 cmH2O. Consequently, to allow complete re-expansion of atelectasis within a lung, it is necessary to apply a pressure at least equal to 30 cmH2O. The application of insufficient pressures cannot be expected to result in complete re-expansion of the lung, but rather in an increase in aeration of already aerated alveoli (whose radius is larger and whose opening pressure is much lower), what, in turn, can lead to over-distension. This is probably what can happen if the PEEP is increased without any previous ARM.

The application of an ARM can also lead to an overdistension phenomenon during a reduced period of time (20 to 30 seconds), contrary to the direct application of a high PEEP which could led to an overdistension lasting a much longer period of time (possibly several hours) and aggravated with each administration of a tidal volume (and thus several times per minute). Chronic lung exposure to overdistension phenomena can induce a disintegration of alveolar collagen fibers (volotrauma), leading to local inflammation (biotrauma) and systemic inflammation by releasing pro-inflammatory molecules (cytokines...) into the bloodstream and led to apoptosis in distant organs (kidney, digestive tract for example).

The optimization of mechanical ventilation requires the search for the optimal PEEP: insufficient, it cannot prevent atelectasis formation; too high, it would lead to alveolar overdistension. In current practice, the PEEP is determined arbitrary or following a stepwise titration, either by incremental or decremental steps. To date, scientific literature is not unequivocal concerning the use of ARMs and their safety. Thus, some teams prefer not to use ARMs and usually apply an upward PEEP level.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Participant)

盲法说明

Statistical analysis will be conducted by an independant statistician not involved in data collection

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

  • Patient over 18 years of age
  • ICU patients with healthy lungs or lungs with Acute Respiratory Distress Syndrome (according to Berlin criteria) under mechanically invasive controlled ventilation (intubation or tracheotomy) in the early phase of admission (< 12h)
  • Patient deeply sedated (BIS between 30 and 50) and possibly under neuromuscular blocking agents (TOF < 2/4 at the orbicular) in case of inspiratory efforts
  • Patient hemodynamically stable with an optimized volemia using a monitoring system (see protocol).
  • Consent to participate
  • Patient benefiting from a Social Security Insurance

排除标准

  • Refusal to participate to the proposed study
  • Obese patient with BMI ≥ 35 kg.cm-2
  • Significant hemodynamic instability defined as > 20% increase in catecholamine doses during the last hour, despite optimization of blood volume according to a pre-established protocol
  • Contraindication to the use of the electro-impedance tomography technique
  • Thoracic lesions
  • Chest bandages
  • Pace-maker/Implantable defibrillator
  • Contraindication to the performance of an alveolar recruitment maneuver
  • Major Emphysema

结局指标

主要结局

Recruited lung volume at each PEEP level between the 2 strategies (incremental or decremental).

时间窗: The last minute of each Peep Step

: The main endpoint is the difference between the recruited lung volume measured by nitrogen washin-washout method at the end of each PEEP level (5th minute) with the basal value measured at the beginning of the protocol, between decremental and incremental stepwise PEEP titration

次要结局

  • Regional impedance variation(Measurement during the last minute of each PEEP step)
  • Atelectrauma(Measurement during the last minute of each PEEP step)
  • Alveolar strain(Measurement during the last minute of each PEEP step)
  • Ventilatory dead space(Measurement during the last minute of each PEEP step)
  • Mechanical power delivered Mechanical power delivered(Measurement during the last minute of each PEEP step)
  • Lung volume variations(Measurement during the last minute of each PEEP step)
  • Recruited lung volume(Measurement during the last minute of each PEEP step)
  • Homogeneity of pulmonary aeration(The last minute of each Peep Step)
  • Ventilatory parameters(Measurement during the last minute of each PEEP step)

研究者

发起方
University Hospital, Clermont-Ferrand
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验