- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04174014
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
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.
Study Overview
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: András Lovas, MD, PhD
- Phone Number: +3662545168
- Email: lovas.andras@med.u-szeged.hu
Study Locations
-
-
Csongrád
-
Szeged, Csongrád, Hungary, 6725
- Recruiting
- University of Szeged, Department of Anesthesiology and Intensive Therapy
-
Contact:
- András Lovas, M.D., Ph.D.
- Phone Number: +3662545168
- Email: lovas.andras@med.u-szeged.hu
-
Contact:
- Petra Dallmann
- Phone Number: +3662545168
- Email: office.aiti@med.u-szeged.hu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Recruitment manoeuvre
|
PEEP increment and decrement
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Highest level of transpulmonary pressure to open up the lung
Time Frame: 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
|
1 minute
|
Changes between the two PEEP level (titrated by transpulmonary pressure measurement vs. optimal PEEP by EIT) estimated in cmH2O control
Time Frame: 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).
|
15 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Gas exchange
Time Frame: 30 minutes
|
Change in PaO2 (mmHg) following recruitment
|
30 minutes
|
Plateau pressure
Time Frame: 30 minutes
|
Change in plateau pressure (cmH2O) under volume control ventilation mode
|
30 minutes
|
Transpulmonary pressure
Time Frame: 30 minutes
|
Change in transpulmonary pressure (cmH2O) following intervention
|
30 minutes
|
Estimation in recruitability
Time Frame: 30 minutes
|
Change in end expiratory lung volume (ml) following intervention
|
30 minutes
|
Antero-to-posterior ventilation ratio
Time Frame: 30 minutes
|
Change in antero-to-posterior ventilation ratio (%) following intervention
|
30 minutes
|
Center of ventilation
Time Frame: 30 minutes
|
Change in center of ventilation (%) following intervention
|
30 minutes
|
Global inhomogeneity index
Time Frame: 30 minutes
|
Change in global inhomogeneity index (%) following intervention
|
30 minutes
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Chiumello D, Brochard L, Marini JJ, Slutsky AS, Mancebo J, Ranieri VM, Thompson BT, Papazian L, Schultz MJ, Amato M, Gattinoni L, Mercat A, Pesenti A, Talmor D, Vincent JL. Respiratory support in patients with acute respiratory distress syndrome: an expert opinion. Crit Care. 2017 Sep 12;21(1):240. doi: 10.1186/s13054-017-1820-0.
- Marini JJ. Evolving concepts for safer ventilation. Crit Care. 2019 Jun 14;23(Suppl 1):114. doi: 10.1186/s13054-019-2406-9.
- Pesenti A, Musch G, Lichtenstein D, Mojoli F, Amato MBP, Cinnella G, Gattinoni L, Quintel M. Imaging in acute respiratory distress syndrome. Intensive Care Med. 2016 May;42(5):686-698. doi: 10.1007/s00134-016-4328-1. Epub 2016 Mar 31.
- Frerichs I, Amato MB, van Kaam AH, Tingay DG, Zhao Z, Grychtol B, Bodenstein M, Gagnon H, Bohm SH, Teschner E, Stenqvist O, Mauri T, Torsani V, Camporota L, Schibler A, Wolf GK, Gommers D, Leonhardt S, Adler A; TREND study group. Chest electrical impedance tomography examination, data analysis, terminology, clinical use and recommendations: consensus statement of the TRanslational EIT developmeNt stuDy group. Thorax. 2017 Jan;72(1):83-93. doi: 10.1136/thoraxjnl-2016-208357. Epub 2016 Sep 5.
- Yoshida T, Brochard L. Esophageal pressure monitoring: why, when and how? Curr Opin Crit Care. 2018 Jun;24(3):216-222. doi: 10.1097/MCC.0000000000000494.
- Costa EL, Borges JB, Melo A, Suarez-Sipmann F, Toufen C Jr, Bohm SH, Amato MB. Bedside estimation of recruitable alveolar collapse and hyperdistension by electrical impedance tomography. Intensive Care Med. 2009 Jun;35(6):1132-7. doi: 10.1007/s00134-009-1447-y. Epub 2009 Mar 3.
- Lovas A, Szakmany T. Haemodynamic Effects of Lung Recruitment Manoeuvres. Biomed Res Int. 2015;2015:478970. doi: 10.1155/2015/478970. Epub 2015 Nov 22.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PTP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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