Optimal PEEP Titration Combining Transpulmonary Pressure Measurement and Electric Impedance Tomography

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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ARDS, Human

Intervention / Treatment
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* Procedure: Recruitment manoeuvre


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Recruitment manoeuvre<br>Volume control (VC) ventilation mode with a tidal volume of 6 mL/kg of ideal body weight P/V tool assessment Baseline measurements CT scan of chest without EIT belt 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 P/V recruitment with target end-PEEP level Removal of EIT belt, CT scan of chest Continuous EIT and transpulmonary pressure measurement with the initial FiO2 and the new PEEP settings | Procedure: Recruitment manoeuvre<br>* PEEP increment and decrement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Highest level of transpulmonary pressure to open up the lung | 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 | 1 minute | 
| Changes between the two PEEP level (titrated by transpulmonary pressure measurement vs. optimal PEEP by EIT) estimated in cmH2O control | 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). | 15 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gas exchange | Change in PaO2 (mmHg) following recruitment | 30 minutes | 
| Plateau pressure | Change in plateau pressure (cmH2O) under volume control ventilation mode | 30 minutes | 
| Transpulmonary pressure | Change in transpulmonary pressure (cmH2O) following intervention | 30 minutes | 
| Estimation in recruitability | Change in end expiratory lung volume (ml) following intervention | 30 minutes | 
| Antero-to-posterior ventilation ratio | Change in antero-to-posterior ventilation ratio (%) following intervention | 30 minutes | 
| Center of ventilation | Change in center of ventilation (%) following intervention | 30 minutes | 
| Global inhomogeneity index | Change in global inhomogeneity index (%) following intervention | 30 minutes |