ARDSNCT06035146
Mechanical Ventilation in Patients With Lung Impairment Controlled by the Mechanical Energy of the Respiratory System
A study testing Mechanical energy monitoring and Conventional mechanical ventilation in people with ARDS and Lung Injury, Ventilator Induced, run by University Hospital Ostrava at 1 site in Czechia.
Trial summary
A project aimed at expanding the monitoring of mechanical energy (ME) in patients on mechanical ventilation (MV), with the aim of contributing to reducing the influence of the device for mechanical ventilation of patients on the lung parenchyma by setting parameters that will lead to lower ventilation energy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ARDS, Lung Injury, Ventilator Induced
- What is being tested?
- Mechanical energy monitoring and Conventional mechanical ventilation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Aug 2022to 31 Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with fully controlled mechanical ventilation
- patients older than 18 years
- patients with lung disease (pneumonia, ARDS)
- expected duration of mechanical ventilation longer than 48 hours
Who cannot join
- pregnant women, when this fact is stated in the admission protocol
- inclusion in the study in a period longer than 24 hours from the start of mechanical ventilation (from admission to the Anesthesiology and Resuscitation Department)
Trial locations and contacts
1 site in 1 country.
Czechia1 site, 1 recruiting
- Recruiting
University Hospital Ostrava
Ostrava, Moravian-Silesian Region, 70852
Jiří Hynčica, 0042059737 ext. 258'7, jiri.hyncica@fno.cz
Filip Burša, MD,PhD
About this study
Official title: Protective Ventilation in Patients With Lung Impairment on Mechanical Ventilation Controlled by the Mechanical Energy of the Respiratory System
A project aimed at expanding the monitoring of mechanical energy (ME) in patients on mechanical ventilation (MV), with the aim of contributing to reducing the influence of the device for mechanical ventilation of patients on the lung parenchyma by setting parameters that will lead to lower ventilation energy.
According to the parameters set on the device for mechanical ventilation, the mechanical energy will be calculated, which the physician in the interventional arm of the study will be able to use to change the mechanical ventilation settings. The physician will follow the best clinical practice, and in the non-intervention group, the MV setting will be conventional.
Read the detailed description
Mechanical ventilation (MV) in patients with acute respiratory failure (ARF) is one of the most common causes of hospitalization in the intensive care unit (ICU). ARF can be associated with severe forms of lung injury, the so-called ARDS (adult respiratory distress syndrome). Despite progress in the management of patients with ARDS, the mortality of these patients remains high, with in-hospital mortality reaching up to 45%. In patients with severe ARDS, mechanical ventilation can damage the lung parenchyma and cause ventilator-induced lung injury (VILI), which further worsens the patient's prognosis.
The result of setting the individual parameters of mechanical ventilation is the energy that the device exerts on the lung parenchyma, which ensures the opening of the lungs and a change in their volume related to gas exchange during breathing.
Routine laboratory values of blood gases and parameters of inflammation (CRP, PCT) will be recorded; which is part of routine clinical practice and standard patient care unrelated to the study.
As part of a prospective randomized study, a system for monitoring mechanical energy at the patient's bedside will be developed. Patients will be randomized into two groups - the intervention arm (mechanical ventilation controlled according to ME) and the non-intervention arm (conventional method of conducting mechanical ventilation).
- Conditions
- ARDS, Lung Injury, Ventilator Induced
- Being tested
- Mechanical energy monitoring, Conventional mechanical ventilation
- Keywords
- mechanical ventilation, adult respiratory distress syndrome, ventilator-induced lung injury, mechanical energy
- Medical subject headings
- Ventilator-Induced Lung Injury, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical energy monitoringProcedure or surgery
Monitoring of the mechanical energy acting on the lung parenchyma during mechanical ventilation.
Conventional mechanical ventilationProcedure or surgery
The conventional procedure of mechanical ventilation controlled according to the physician's decision.
| Study group | Role | What they receive |
|---|---|---|
| Mechanical energy monitoring | Experimental | In the study subjects randomized into this arm, the value of mechanical energy will be monitored during mechanical ventilation. Receives: Procedure: Mechanical energy monitoring |
| Conventional mechanical ventilation | Active comparator | Study subjects randomized into this arm will receive conventional mechanical ventilation, to the best of the physician's knowledge. Receives: Procedure: Conventional mechanical ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The level of mechanical energy (in Joules/min)
The level of mechanical energy will be measured (in Joules/min) in both study arms.
Measured: up to 14 days
Secondary outcomes (3)
The number of days on mechanical ventilation
The number of days on mechanical ventilation will be observed in both study arms.
Measured: up to 14 days
The effect of mechanical energy on patient mortality
The effect of mechanical energy on patient mortality will be analysed in both study arms. A mortality rate is the number of deaths due to a disease divided by the total population.
Measured: up to 14 days
The effect of mechanical energy on hospital mortality
The effect of mechanical energy on hospital mortality will be analysed in both study arms. A mortality rate is the number of deaths due to a disease divided by the total population.
Measured: up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start1 Aug 2022
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for ARDSStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study subjects will be randomized into two parallel groups.
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Ostrava
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Filip Burša, MD,PhD, Principal investigator, University Hospital Ostrava
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06035146
- Sponsor's protocol ID
- 25/RVO-FNOs/2022
- Status last verified
- Sep 2023
- First submitted
- 15 Feb 2023
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data available to other researchers. The data may be provided upon request.
Publications
Papazian L, Calfee CS, Chiumello D, Luyt CE, Meyer NJ, Sekiguchi H, Matthay MA, Meduri GU. Diagnostic workup for ARDS patients. Intensive Care Med. 2016 May;42(5):674-685. doi: 10.1007/s00134-016-4324-5. Epub 2016 Mar 23.
PubMed 27007111Maca J, Jor O, Holub M, Sklienka P, Bursa F, Burda M, Janout V, Sevcik P. Past and Present ARDS Mortality Rates: A Systematic Review. Respir Care. 2017 Jan;62(1):113-122. doi: 10.4187/respcare.04716. Epub 2016 Nov 1.
PubMed 27803355Acute Respiratory Distress Syndrome Network; Brower RG, Matthay MA, Morris A, Schoenfeld D, Thompson BT, Wheeler A. Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. N Engl J Med. 2000 May 4;342(18):1301-8. doi: 10.1056/NEJM200005043421801.
PubMed 10793162Rittayamai N, Brochard L. Recent advances in mechanical ventilation in patients with acute respiratory distress syndrome. Eur Respir Rev. 2015 Mar;24(135):132-40. doi: 10.1183/09059180.00012414.
PubMed 25726563Guerin C, Papazian L, Reignier J, Ayzac L, Loundou A, Forel JM; investigators of the Acurasys and Proseva trials. Effect of driving pressure on mortality in ARDS patients during lung protective mechanical ventilation in two randomized controlled trials. Crit Care. 2016 Nov 29;20(1):384. doi: 10.1186/s13054-016-1556-2.
PubMed 27894328Gattinoni L, Marini JJ, Pesenti A, Quintel M, Mancebo J, Brochard L. The "baby lung" became an adult. Intensive Care Med. 2016 May;42(5):663-673. doi: 10.1007/s00134-015-4200-8. Epub 2016 Jan 18.
PubMed 26781952de Prost N, Ricard JD, Saumon G, Dreyfuss D. Ventilator-induced lung injury: historical perspectives and clinical implications. Ann Intensive Care. 2011 Jul 23;1(1):28. doi: 10.1186/2110-5820-1-28.
PubMed 21906379Nieman GF, Satalin J, Andrews P, Habashi NM, Gatto LA. Lung stress, strain, and energy load: engineering concepts to understand the mechanism of ventilator-induced lung injury (VILI). Intensive Care Med Exp. 2016 Dec;4(1):16. doi: 10.1186/s40635-016-0090-5. Epub 2016 Jun 18.
PubMed 27316442Gattinoni L, Tonetti T, Cressoni M, Cadringher P, Herrmann P, Moerer O, Protti A, Gotti M, Chiurazzi C, Carlesso E, Chiumello D, Quintel M. Ventilator-related causes of lung injury: the mechanical power. Intensive Care Med. 2016 Oct;42(10):1567-1575. doi: 10.1007/s00134-016-4505-2. Epub 2016 Sep 12.
PubMed 27620287Cressoni M, Gotti M, Chiurazzi C, Massari D, Algieri I, Amini M, Cammaroto A, Brioni M, Montaruli C, Nikolla K, Guanziroli M, Dondossola D, Gatti S, Valerio V, Vergani GL, Pugni P, Cadringher P, Gagliano N, Gattinoni L. Mechanical Power and Development of Ventilator-induced Lung Injury. Anesthesiology. 2016 May;124(5):1100-8. doi: 10.1097/ALN.0000000000001056.
PubMed 26872367Chiumello D, Gotti M, Guanziroli M, Formenti P, Umbrello M, Pasticci I, Mistraletti G, Busana M. Bedside calculation of mechanical power during volume- and pressure-controlled mechanical ventilation. Crit Care. 2020 Jul 11;24(1):417. doi: 10.1186/s13054-020-03116-w.
PubMed 32653011Giosa L, Busana M, Pasticci I, Bonifazi M, Macri MM, Romitti F, Vassalli F, Chiumello D, Quintel M, Marini JJ, Gattinoni L. Mechanical power at a glance: a simple surrogate for volume-controlled ventilation. Intensive Care Med Exp. 2019 Nov 27;7(1):61. doi: 10.1186/s40635-019-0276-8.
PubMed 31773328Becher T, van der Staay M, Schadler D, Frerichs I, Weiler N. Calculation of mechanical power for pressure-controlled ventilation. Intensive Care Med. 2019 Sep;45(9):1321-1323. doi: 10.1007/s00134-019-05636-8. Epub 2019 May 17. No abstract available.
PubMed 31101961Serpa Neto A, Deliberato RO, Johnson AEW, Bos LD, Amorim P, Pereira SM, Cazati DC, Cordioli RL, Correa TD, Pollard TJ, Schettino GPP, Timenetsky KT, Celi LA, Pelosi P, Gama de Abreu M, Schultz MJ; PROVE Network Investigators. Mechanical power of ventilation is associated with mortality in critically ill patients: an analysis of patients in two observational cohorts. Intensive Care Med. 2018 Nov;44(11):1914-1922. doi: 10.1007/s00134-018-5375-6. Epub 2018 Oct 5.
PubMed 30291378Mietto C, Malbrain ML, Chiumello D. Transpulmonary pressure monitoring during mechanical ventilation: a bench-to-bedside review. Anaesthesiol Intensive Ther. 2015;47 Spec No:s27-37. doi: 10.5603/AIT.a2015.0065. Epub 2015 Nov 17.
PubMed 26575165
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protective Ventilation in Patients With Lung Impairment on Mechanical Ventilation Controlled by the Mechanical Energy of the Respiratory System
- ClinicalTrials.gov ID
- NCT06035146
- Acronym / sponsor ID
- 25/RVO-FNOs/2022
- Conditions
- ARDS, Lung Injury, Ventilator Induced
- Keywords
- mechanical ventilation, adult respiratory distress syndrome, ventilator-induced lung injury, mechanical energy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- University Hospital OstravaUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 13 Sep 2023 (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.
A project aimed at expanding the monitoring of mechanical energy (ME) in patients on mechanical ventilation (MV), with the aim of contributing to reducing the influence of the device for mechanical ventilation of patients on the lung parenchyma by setting parameters that will lead to lower ventilation energy.
According to the parameters set on the device for mechanical ventilation, the mechanical energy will be calculated, which the physician in the interventional arm of the study will be able to use to change the mechanical ventilation settings. The physician will follow the best clinical practice, and in the non-intervention group, the MV setting will be conventional.
Detailed description
Mechanical ventilation (MV) in patients with acute respiratory failure (ARF) is one of the most common causes of hospitalization in the intensive care unit (ICU). ARF can be associated with severe forms of lung injury, the so-called ARDS (adult respiratory distress syndrome). Despite progress in the management of patients with ARDS, the mortality of these patients remains high, with in-hospital mortality reaching up to 45%. In patients with severe ARDS, mechanical ventilation can damage the lung parenchyma and cause ventilator-induced lung injury (VILI), which further worsens the patient's prognosis.
The result of setting the individual parameters of mechanical ventilation is the energy that the device exerts on the lung parenchyma, which ensures the opening of the lungs and a change in their volume related to gas exchange during breathing.
Routine laboratory values of blood gases and parameters of inflammation (CRP, PCT) will be recorded; which is part of routine clinical practice and standard patient care unrelated to the study.
As part of a prospective randomized study, a system for monitoring mechanical energy at the patient's bedside will be developed. Patients will be randomized into two groups - the intervention arm (mechanical ventilation controlled according to ME) and the non-intervention arm (conventional method of conducting mechanical ventilation).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study subjects will be randomized into two parallel groups.
| Arm | Type | Receives |
|---|---|---|
| Mechanical energy monitoring | Experimental | Procedure: Mechanical energy monitoringIn the study subjects randomized into this arm, the value of mechanical energy will be monitored during mechanical ventilation. |
| Conventional mechanical ventilation | Active comparator | Procedure: Conventional mechanical ventilationStudy subjects randomized into this arm will receive conventional mechanical ventilation, to the best of the physician's knowledge. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients with fully controlled mechanical ventilation
- patients older than 18 years
- patients with lung disease (pneumonia, ARDS)
- expected duration of mechanical ventilation longer than 48 hours
Key exclusion criteria (2 listed)
- pregnant women, when this fact is stated in the admission protocol
- inclusion in the study in a period longer than 24 hours from the start of mechanical ventilation (from admission to the Anesthesiology and Resuscitation Department)
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 |
|---|---|---|
| Mechanical energy monitoringMonitoring of the mechanical energy acting on the lung parenchyma during mechanical ventilation. | Procedure or surgery | Mechanical energy monitoring |
| Conventional mechanical ventilationThe conventional procedure of mechanical ventilation controlled according to the physician's decision. | Procedure or surgery | Conventional mechanical ventilation |
Primary outcome
The level of mechanical energy (in Joules/min)
Time frame: up to 14 days
The level of mechanical energy will be measured (in Joules/min) in both study arms.
3 secondary outcomes
The number of days on mechanical ventilation
Time frame: up to 14 days
The effect of mechanical energy on patient mortality
Time frame: up to 14 days
The effect of mechanical energy on hospital mortality
Time frame: up to 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- Background: PubMed 27007111Papazian L, Calfee CS, Chiumello D, Luyt CE, Meyer NJ, Sekiguchi H, Matthay MA, Meduri GU. Diagnostic workup for ARDS patients. Intensive Care Med. 2016 May;42(5):674-685. doi: 10.1007/s00134-016-4324-5. Epub 2016 Mar 23.
- Background: PubMed 27803355Maca J, Jor O, Holub M, Sklienka P, Bursa F, Burda M, Janout V, Sevcik P. Past and Present ARDS Mortality Rates: A Systematic Review. Respir Care. 2017 Jan;62(1):113-122. doi: 10.4187/respcare.04716. Epub 2016 Nov 1.
- Background: PubMed 10793162Acute Respiratory Distress Syndrome Network; Brower RG, Matthay MA, Morris A, Schoenfeld D, Thompson BT, Wheeler A. Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. N Engl J Med. 2000 May 4;342(18):1301-8. doi: 10.1056/NEJM200005043421801.
- Background: PubMed 25726563Rittayamai N, Brochard L. Recent advances in mechanical ventilation in patients with acute respiratory distress syndrome. Eur Respir Rev. 2015 Mar;24(135):132-40. doi: 10.1183/09059180.00012414.
- Background: PubMed 27894328Guerin C, Papazian L, Reignier J, Ayzac L, Loundou A, Forel JM; investigators of the Acurasys and Proseva trials. Effect of driving pressure on mortality in ARDS patients during lung protective mechanical ventilation in two randomized controlled trials. Crit Care. 2016 Nov 29;20(1):384. doi: 10.1186/s13054-016-1556-2.
- Background: PubMed 26781952Gattinoni L, Marini JJ, Pesenti A, Quintel M, Mancebo J, Brochard L. The "baby lung" became an adult. Intensive Care Med. 2016 May;42(5):663-673. doi: 10.1007/s00134-015-4200-8. Epub 2016 Jan 18.
- Background: PubMed 21906379de Prost N, Ricard JD, Saumon G, Dreyfuss D. Ventilator-induced lung injury: historical perspectives and clinical implications. Ann Intensive Care. 2011 Jul 23;1(1):28. doi: 10.1186/2110-5820-1-28.
- Background: PubMed 27316442Nieman GF, Satalin J, Andrews P, Habashi NM, Gatto LA. Lung stress, strain, and energy load: engineering concepts to understand the mechanism of ventilator-induced lung injury (VILI). Intensive Care Med Exp. 2016 Dec;4(1):16. doi: 10.1186/s40635-016-0090-5. Epub 2016 Jun 18.
- Background: PubMed 27620287Gattinoni L, Tonetti T, Cressoni M, Cadringher P, Herrmann P, Moerer O, Protti A, Gotti M, Chiurazzi C, Carlesso E, Chiumello D, Quintel M. Ventilator-related causes of lung injury: the mechanical power. Intensive Care Med. 2016 Oct;42(10):1567-1575. doi: 10.1007/s00134-016-4505-2. Epub 2016 Sep 12.
- Background: PubMed 26872367Cressoni M, Gotti M, Chiurazzi C, Massari D, Algieri I, Amini M, Cammaroto A, Brioni M, Montaruli C, Nikolla K, Guanziroli M, Dondossola D, Gatti S, Valerio V, Vergani GL, Pugni P, Cadringher P, Gagliano N, Gattinoni L. Mechanical Power and Development of Ventilator-induced Lung Injury. Anesthesiology. 2016 May;124(5):1100-8. doi: 10.1097/ALN.0000000000001056.
- Background: PubMed 32653011Chiumello D, Gotti M, Guanziroli M, Formenti P, Umbrello M, Pasticci I, Mistraletti G, Busana M. Bedside calculation of mechanical power during volume- and pressure-controlled mechanical ventilation. Crit Care. 2020 Jul 11;24(1):417. doi: 10.1186/s13054-020-03116-w.
- Background: PubMed 31773328Giosa L, Busana M, Pasticci I, Bonifazi M, Macri MM, Romitti F, Vassalli F, Chiumello D, Quintel M, Marini JJ, Gattinoni L. Mechanical power at a glance: a simple surrogate for volume-controlled ventilation. Intensive Care Med Exp. 2019 Nov 27;7(1):61. doi: 10.1186/s40635-019-0276-8.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data available to other researchers. The data may be provided upon request.
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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.
Filip Burša, MD,PhD principal investigator
University Hospital Ostrava
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mechanical energy monitoring and Conventional mechanical ventilation in people with ARDS and Lung Injury, Ventilator Induced, run by University Hospital Ostrava at 1 site in Czechia.
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 4 inclusion and 2 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 13 Sep 2023. 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 Czechia. 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 Jiří Hynčica (0042059737 ext. 2587, jiri.hyncica@fno.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The level of mechanical energy (in Joules/min) (time frame: up to 14 days). 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 NCT06035146, which also lists 16 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 13 Sep 2023.