ARDS, HumanNCT04174014
Optimal PEEP Titration Combining Transpulmonary Pressure Measurement and Electric Impedance Tomography
A study testing Recruitment manoeuvre in people with ARDS, Human, run by Kiskunhalas Semmelweis Hospital the Teaching Hospital of the University of Szeged at 1 site in Hungary.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- ARDS, Human
- What is being tested?
- Recruitment manoeuvre
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteHungary
- Study dates
- 1 Oct 2019to 1 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Hungary1 site, 1 recruiting
- Recruiting
University of Szeged, Department of Anesthesiology and Intensive Therapy
Szeged, Csongrád megye, 6725
András Lovas, M.D., Ph.D., +3662545168, lovas.andras@med.u-szeged.hu
Petra Dallmann, +3662545168, office.aiti@med.u-szeged.hu
About this study
Official title: 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.
Read the 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.
- Conditions
- ARDS, Human
- Being tested
- Recruitment manoeuvre
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recruitment manoeuvreProcedure or surgery
PEEP increment and decrement
| Study group | Role | What they receive |
|---|---|---|
| Recruitment manoeuvre | Experimental | 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 Receives: Procedure: Recruitment manoeuvre |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 minute
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).
Measured: 15 minutes
Secondary outcomes (7)
Gas exchange
Change in PaO2 (mmHg) following recruitment
Measured: 30 minutes
Plateau pressure
Change in plateau pressure (cmH2O) under volume control ventilation mode
Measured: 30 minutes
Transpulmonary pressure
Change in transpulmonary pressure (cmH2O) following intervention
Measured: 30 minutes
Estimation in recruitability
Change in end expiratory lung volume (ml) following intervention
Measured: 30 minutes
Antero-to-posterior ventilation ratio
Change in antero-to-posterior ventilation ratio (%) following intervention
Measured: 30 minutes
Center of ventilation
Change in center of ventilation (%) following intervention
Measured: 30 minutes
Global inhomogeneity index
Change in global inhomogeneity index (%) following intervention
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2019
- Study start1 Oct 2019
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for ARDS, HumanStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kiskunhalas Semmelweis Hospital the Teaching Hospital of the University of Szeged
- Sponsor type
- Other government
- Collaborators
- Budapest University of Technology and Economics, Hochschule Furtwangen University, Szeged University
- Responsible party
- Principal investigator, András Lovas, Kiskunhalas Semmelweis Hospital the Teaching Hospital of the University of Szeged
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04174014
- Sponsor's protocol ID
- PTP
- Status last verified
- Feb 2024
- First submitted
- 3 Nov 2019
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 28899408Marini JJ. Evolving concepts for safer ventilation. Crit Care. 2019 Jun 14;23(Suppl 1):114. doi: 10.1186/s13054-019-2406-9.
PubMed 31200734Pesenti 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.
PubMed 27033882Frerichs 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.
PubMed 27596161Yoshida 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.
PubMed 29601320Costa 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.
PubMed 19255741Lovas A, Szakmany T. Haemodynamic Effects of Lung Recruitment Manoeuvres. Biomed Res Int. 2015;2015:478970. doi: 10.1155/2015/478970. Epub 2015 Nov 22.
PubMed 26682219
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estimation of Optimal PEEP by Transpulmonary Pressure Measurement Following Recruitment Manoeuvre Under Computer Tomography and Electric Impedance Tomography Control
- ClinicalTrials.gov ID
- NCT04174014
- Acronym / sponsor ID
- PTP
- Conditions
- ARDS, Human
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Kiskunhalas Semmelweis Hospital the Teaching Hospital of the University of SzegedOther government
- Collaborators
- Budapest University of Technology and Economics, Hochschule Furtwangen University, Szeged University
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 22 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Recruitment manoeuvre | Experimental | Procedure: Recruitment manoeuvre1. 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 |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (8 listed)
- age under 18
- pregnancy
- pulmonectomy, lung resection in the past medical history
- clinically end stage COPD
- sever hemodynamic instability (vasopressor refractory shock)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recruitment manoeuvrePEEP increment and decrement | Procedure or surgery | Recruitment manoeuvre |
Primary outcome
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
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).
7 secondary outcomes
Gas exchange
Time frame: 30 minutes
Plateau pressure
Time frame: 30 minutes
Transpulmonary pressure
Time frame: 30 minutes
Estimation in recruitability
Time frame: 30 minutes
Antero-to-posterior ventilation ratio
Time frame: 30 minutes
Center of ventilation
Time frame: 30 minutes
Global inhomogeneity index
Time frame: 30 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Results publication: PubMed 28899408Chiumello 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 publication: PubMed 31200734Marini JJ. Evolving concepts for safer ventilation. Crit Care. 2019 Jun 14;23(Suppl 1):114. doi: 10.1186/s13054-019-2406-9.
- Results publication: PubMed 27033882Pesenti 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 publication: PubMed 27596161Frerichs 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 publication: PubMed 29601320Yoshida 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 publication: PubMed 19255741Costa 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 publication: PubMed 26682219Lovas A, Szakmany T. Haemodynamic Effects of Lung Recruitment Manoeuvres. Biomed Res Int. 2015;2015:478970. doi: 10.1155/2015/478970. Epub 2015 Nov 22.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Recruitment manoeuvre in people with ARDS, Human, run by Kiskunhalas Semmelweis Hospital the Teaching Hospital of the University of Szeged at 1 site in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact András Lovas, MD, PhD (+3662545168, lovas.andras@med.u-szeged.hu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Highest level of transpulmonary pressure to open up the lung (time frame: 1 minute). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04174014, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024.