Optimal PEEP Titration Combining Transpulmonary Pressure Measurement and Electric Impedance Tomography

ARDS, Human Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04174014
• Other study ID #: PTP
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: July 1, 2025

Study information

• Verified date: February 2024
• Source: Kiskunhalas Semmelweis Hospital the Teaching Hospital of the University of Szeged
• Contact: András Lovas, MD, PhD
• Phone: +3662545168
• Email: lovas.andras[@]med.u-szeged.hu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: July 1, 2025
• Est. primary completion date: July 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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)

Related Conditions & MeSH terms

• ARDS, Human
• Respiratory Distress Syndrome

Intervention

Procedure:
• Recruitment manoeuvre
PEEP increment and decrement

Locations

Country	Name	City	State
Hungary	University of Szeged, Department of Anesthesiology and Intensive Therapy	Szeged	Csongrád

Sponsors (4)

Lead Sponsor	Collaborator
Kiskunhalas Semmelweis Hospital the Teaching Hospital of the University of Szeged	Budapest University of Technology and Economics, Hochschule Furtwangen University, Szeged University

Country where clinical trial is conducted

Hungary, 

References & Publications (7)

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 exper — View Citation

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/s00134-009-1 — View Citation

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 impedanc — View Citation

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. — View Citation

Marini JJ. Evolving concepts for safer ventilation. Crit Care. 2019 Jun 14;23(Suppl 1):114. doi: 10.1186/s13054-019-2406-9. — View Citation

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. — View Citation

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. — View Citation

Outcome

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