Clinical trial NCT04174014: Optimal PEEP Titration Combining Transpulmonary Pressure Measurement and Electric Impedance Tomography
Official title: Estimation of Optimal PEEP by Transpulmonary Pressure Measurement Following Recruitment Manoeuvre Under Computer Tomography and Electric Impedance Tomography Control
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: ARDS, Human
Lead sponsor: Kiskunhalas Semmelweis Hospital the Teaching Hospital of the University of Szeged
Sponsor class: OTHER_GOV
Collaborators: name: Budapest University of Technology and Economics
name: Hochschule Furtwangen University
name: Szeged University
First posted: 2019-11-22
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Highest level of transpulmonary pressure to open up the lung
timeFrame: 1 minute
measure: Changes between the two PEEP level (titrated by transpulmonary pressure measurement vs. optimal PEEP by EIT) estimated in cmH2O control
timeFrame: 15 minutes
Secondary outcomes:
measure: Gas exchange
timeFrame: 30 minutes
measure: Plateau pressure
timeFrame: 30 minutes
measure: Transpulmonary pressure
timeFrame: 30 minutes
measure: Estimation in recruitability
timeFrame: 30 minutes
measure: Antero-to-posterior ventilation ratio
timeFrame: 30 minutes
measure: Center of ventilation
timeFrame: 30 minutes
measure: Global inhomogeneity index
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Szeged
country: Hungary
facility: University of Szeged, Department of Anesthesiology and Intensive Therapy
state: Csongrád
Study officials:
References:
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