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Optimal PEEP Titration Combining Transpulmonary Pressure Measurement and Electric Impedance Tomography

Primary Purpose

ARDS, Human

Status
Recruiting
Phase
Not Applicable
Locations
Hungary
Study Type
Interventional
Intervention
Recruitment manoeuvre
Sponsored by
Szeged University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ARDS, Human

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • University of Szeged, Department of Anesthesiology and Intensive TherapyRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Recruitment manoeuvre

Arm Description

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

Outcomes

Primary Outcome Measures

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
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).

Secondary Outcome Measures

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

Full Information

First Posted
November 3, 2019
Last Updated
February 11, 2022
Sponsor
Szeged University
Collaborators
Budapest University of Technology and Economics, Hochschule Furtwangen University
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1. Study Identification

Unique Protocol Identification Number
NCT04174014
Brief Title
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

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
October 1, 2022 (Anticipated)
Study Completion Date
October 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Szeged University
Collaborators
Budapest University of Technology and Economics, Hochschule Furtwangen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ARDS, Human

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Recruitment manoeuvre
Arm Type
Experimental
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Recruitment manoeuvre
Intervention Description
PEEP increment and decrement
Primary Outcome Measure Information:
Title
Highest level of transpulmonary pressure to open up the lung
Description
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
Time Frame
1 minute
Title
Changes between the two PEEP level (titrated by transpulmonary pressure measurement vs. optimal PEEP by EIT) estimated in cmH2O control
Description
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).
Time Frame
15 minutes
Secondary Outcome Measure Information:
Title
Gas exchange
Description
Change in PaO2 (mmHg) following recruitment
Time Frame
30 minutes
Title
Plateau pressure
Description
Change in plateau pressure (cmH2O) under volume control ventilation mode
Time Frame
30 minutes
Title
Transpulmonary pressure
Description
Change in transpulmonary pressure (cmH2O) following intervention
Time Frame
30 minutes
Title
Estimation in recruitability
Description
Change in end expiratory lung volume (ml) following intervention
Time Frame
30 minutes
Title
Antero-to-posterior ventilation ratio
Description
Change in antero-to-posterior ventilation ratio (%) following intervention
Time Frame
30 minutes
Title
Center of ventilation
Description
Change in center of ventilation (%) following intervention
Time Frame
30 minutes
Title
Global inhomogeneity index
Description
Change in global inhomogeneity index (%) following intervention
Time Frame
30 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
András Lovas, MD, PhD
Phone
+3662545168
Email
lovas.andras@med.u-szeged.hu
Facility Information:
Facility Name
University of Szeged, Department of Anesthesiology and Intensive Therapy
City
Szeged
State/Province
Csongrád
ZIP/Postal Code
6725
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
András Lovas, M.D., Ph.D.
Phone
+3662545168
Email
lovas.andras@med.u-szeged.hu
First Name & Middle Initial & Last Name & Degree
Petra Dallmann
Phone
+3662545168
Email
office.aiti@med.u-szeged.hu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28899408
Citation
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.
Results Reference
result
PubMed Identifier
31200734
Citation
Marini JJ. Evolving concepts for safer ventilation. Crit Care. 2019 Jun 14;23(Suppl 1):114. doi: 10.1186/s13054-019-2406-9.
Results Reference
result
PubMed Identifier
27033882
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.
Results Reference
result
PubMed Identifier
27596161
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 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.
Results Reference
result
PubMed Identifier
29601320
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.
Results Reference
result
PubMed Identifier
19255741
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/s00134-009-1447-y. Epub 2009 Mar 3.
Results Reference
result
PubMed Identifier
26682219
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.
Results Reference
result

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Optimal PEEP Titration Combining Transpulmonary Pressure Measurement and Electric Impedance Tomography

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