Optimal PEEP Titration Combining Transpulmonary Pressure Measurement and Electric Impedance Tomography

NCT ID: NCT04174014

Last Updated: 2024-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-01

Study Completion Date

2025-07-01

Brief Summary

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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

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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.

Conditions

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ARDS, Human

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Recruitment manoeuvre

1. Volume control (VC) ventilation mode with a tidal volume of 6 mL/kg of ideal body weight
2. P/V tool assessment
3. Baseline measurements
4. CT scan of chest without EIT belt
5. 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
6. P/V recruitment with target end-PEEP level
7. Removal of EIT belt, CT scan of chest
8. Continuous EIT and transpulmonary pressure measurement with the initial FiO2 and the new PEEP settings

Group Type EXPERIMENTAL

Recruitment manoeuvre

Intervention Type PROCEDURE

PEEP increment and decrement

Interventions

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Recruitment manoeuvre

PEEP increment and decrement

Intervention Type PROCEDURE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Budapest University of Technology and Economics

OTHER

Sponsor Role collaborator

Hochschule Furtwangen University

OTHER

Sponsor Role collaborator

Szeged University

OTHER

Sponsor Role collaborator

Kiskunhalas Semmelweis Hospital the Teaching Hospital of the University of Szeged

OTHER_GOV

Sponsor Role lead

Responsible Party

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András Lovas

MD, PhD, EDIC, EDAIC, head of department

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Szeged, Department of Anesthesiology and Intensive Therapy

Szeged, Csongrád megye, Hungary

Site Status RECRUITING

Countries

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Hungary

Central Contacts

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András Lovas, MD, PhD

Role: CONTACT

+3662545168

Facility Contacts

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András Lovas, M.D., Ph.D.

Role: primary

+3662545168

Petra Dallmann

Role: backup

+3662545168

References

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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.

Reference Type RESULT
PMID: 28899408 (View on PubMed)

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

Reference Type RESULT
PMID: 31200734 (View on PubMed)

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.

Reference Type RESULT
PMID: 27033882 (View on PubMed)

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.

Reference Type RESULT
PMID: 27596161 (View on PubMed)

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.

Reference Type RESULT
PMID: 29601320 (View on PubMed)

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.

Reference Type RESULT
PMID: 19255741 (View on PubMed)

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.

Reference Type RESULT
PMID: 26682219 (View on PubMed)

Other Identifiers

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PTP

Identifier Type: -

Identifier Source: org_study_id

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