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Optimal PEEP Titration Combining Transpulmonary Pressure Measurement and Electric Impedance Tomography

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04174014
Enrollment
10
Registered
2019-11-22
Start date
2019-10-01
Completion date
2025-07-01
Last updated
2024-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ARDS, Human

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.

Interventions

PEEP increment and decrement

Sponsors

Budapest University of Technology and Economics
CollaboratorOTHER
Hochschule Furtwangen University
CollaboratorOTHER
Szeged University
CollaboratorOTHER
Kiskunhalas Semmelweis Hospital the Teaching Hospital of the University of Szeged
Lead SponsorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Highest level of transpulmonary pressure to open up the lung1 minuteEstimation 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 control15 minutesPEEP 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).

Secondary

MeasureTime frameDescription
Transpulmonary pressure30 minutesChange in transpulmonary pressure (cmH2O) following intervention
Estimation in recruitability30 minutesChange in end expiratory lung volume (ml) following intervention
Gas exchange30 minutesChange in PaO2 (mmHg) following recruitment
Center of ventilation30 minutesChange in center of ventilation (%) following intervention
Global inhomogeneity index30 minutesChange in global inhomogeneity index (%) following intervention
Antero-to-posterior ventilation ratio30 minutesChange in antero-to-posterior ventilation ratio (%) following intervention
Plateau pressure30 minutesChange in plateau pressure (cmH2O) under volume control ventilation mode

Countries

Hungary

Contacts

Primary ContactAndrás Lovas, MD, PhD
lovas.andras@med.u-szeged.hu+3662545168

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026