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临床试验/NCT04174014
NCT04174014Unknown不适用

Estimation of Optimal PEEP by Transpulmonary Pressure Measurement Following Recruitment Manoeuvre Under Computer Tomography and Electric Impedance Tomography Control

Kiskunhalas Semmelweis Hospital the Teaching Hospital of the University of Szeged1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2019年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
10
试验地点
1
主要终点
Highest level of transpulmonary pressure to open up the lung

研究概览

简要总结

Diagnosis and treatment of the hypoxic respiratory failure induced by severe atelectasis with the background of acute lung injury is challenging for the intensive care physicians. Mechanical ventilation commenced with grave hypoxemia is one of the most common organ support therapies applied in the critically ill. However, respiratory therapy can improve gas exchange until the elimination of the damaging pathomechanism and the regeneration of the lung tissue, mechanical ventilation is a double edge sword. Mechanical ventilation induced volu- and barotrauma with the cyclic shearing forces can evoke further lung injury on its own.

Computer tomography (CT) of the chest is still the gold standard in the diagnostic protocols of the hypoxemic respiratory failure. However, CT can reveal scans not just about the whole bilateral lung parenchyma but also about the mediastinal organs, it requires the transportation of the critically ill and exposes the patient to extra radiation. At the same time the reproducibility of the CT is poor and it offers just a snapshot about the ongoing progression of the disease. On the contrary electric impedance tomography (EIT) provides a real time, dynamic and easily reproducible information about one lung segment at the bed side. At the same time these picture imaging techniques are supplemented by the pressure parameters and lung mechanical properties assigned and displayed by the ventilator. The latter can be ameliorated by the measurement of the intrapleural pressure. Through with this extra information transpulmonary pressure can be estimated what directly effects the alveoli.

Unfortunately, parameters measured by the respirator provide only a global status about the state of the lungs. On the contrary acute lung injury is characterized by focal injuries of the lung parenchyma where undamaged alveoli take part in the gas exchange next to the impaired ones. EIT can aim the identification of these lesions by the assessment of the focal mechanical properties when parameters measured by the ventilator are also involved. The latter one can not just take a role in the diagnosis but with the support of it the effectivity of the alveolar recruitment can be estimated and optimal ventilator parameters can be determined preventing further damage caused by the mechanical stress.

详细描述

Following PEEP increment and decrement alveolar recruitment manoeuvre optimal PEEP would be assessed by transpulmonary pressure measurement to keep open up the lung. Physicians are lack of data at which pressure the most alveoli are recruited and if 40 cmH2O of pressure is really required for complete recruitment. By CT scan of chest and continuous EIT measurement rate of recruitment would be assessed.

研究设计

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

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Orotracheally intubated patients ventilated in volume control mode with moderate and severe hypoxic respiratory failure according to the ARDS Berlin definition.
  • •100 Hgmm ≤ PaO2/FiO2 ≤ 200 Hgmm, PEEP ≥ 5 cmH2O (moderate) or PaO2/FiO2 ≤ 100 Hgmm, PEEP ≥ 5 cmH2O (sever)

排除标准

  • •age under 18
  • •pregnancy
  • •pulmonectomy, lung resection in the past medical history
  • •clinically end stage COPD
  • •sever hemodynamic instability (vasopressor refractory shock)
  • •sever bullous emphysema and/or spontaneous pneumothorax in the past medical history
  • •chest drainage in situ due to pneumothorax and/or bronchopleural fistula
  • •contraindication of the application of oesophageal balloon catheter (oesophageal ulcer, oesophageal perforation, oesophageal diverticulosis, oesophageal cancer, oesophageal varices, recent operation on oesophagus and/or stomach, sever coagulopathy)

研究组 & 干预措施

Recruitment manoeuvre

Experimental
  1. Volume control (VC) ventilation mode with a tidal volume of 6 mL/kg of ideal body weight
  2. P/V tool assessment
  3. Baseline measurements
  4. CT scan of chest without EIT belt
  5. Re-establishment of EIT belt, continuous EIT and transpulmonary pressure measurement during the recruitment and de-recruitment manoeuvre.

increment phase:

  • constant volume settings
  • increasing PEEP with 4 cmH2O following each 10 consecutive controlled breath until reaching a peak pressure of 40 cmH2O

decrement phase:

  • constant volume settings
  • decreasing PEEP with 4 cmH2O following each 10 consecutive controlled breath not lower than 2 cmH20 from target PEEP
  • target PEEP level is defined where the end-expiratory transpulmonary pressure is 0-1 cmH2O
  1. P/V recruitment with target end-PEEP level
  2. Removal of EIT belt, CT scan of chest
  3. Continuous EIT and transpulmonary pressure measurement with the initial FiO2 and the new PEEP settings

干预措施: Recruitment manoeuvre (Procedure)

结局指标

主要结局

Highest level of transpulmonary pressure to open up the lung

时间窗: 1 minute

Estimation of the highest level of transpulmonary pressure (cmH2O) during the increment PEEP phase when the end-expiratory lung volume (ml) can not be increased further

Changes between the two PEEP level (titrated by transpulmonary pressure measurement vs. optimal PEEP by EIT) estimated in cmH2O control

时间窗: 15 minutes

PEEP settings by keeping the transpulmonary pressure around 1 cmH2O at an end-expiratory hold manoeuvre really represents the most optimal circumstances by electric impedance tomography as well. Optimal circumstances by EIT would be represented by at the crossover point of hyperdistension/collapse % curves plotted versus PEEP. Difference between the two PEEP level (titrated by transpulmonary pressure measurement vs. optimal PEEP by EIT described previously) would be estimated (cmH2O).

次要结局

  • Antero-to-posterior ventilation ratio(30 minutes)
  • Center of ventilation(30 minutes)
  • Gas exchange(30 minutes)
  • Plateau pressure(30 minutes)
  • Estimation in recruitability(30 minutes)
  • Transpulmonary pressure(30 minutes)
  • Global inhomogeneity index(30 minutes)

研究者

发起方
Kiskunhalas Semmelweis Hospital the Teaching Hospital of the University of Szeged
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

András Lovas

MD, PhD, EDIC, EDAIC, head of department

Kiskunhalas Semmelweis Hospital the Teaching Hospital of the University of Szeged

研究点 (1)

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