Mechanical Ventilation in Patients With Lung Impairment Controlled by the Mechanical Energy of the Respiratory System
NCT ID: NCT06035146
Last Updated: 2023-09-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
34 participants
INTERVENTIONAL
2022-08-01
2025-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Cross-sectional, Observational, Prospective and Analytical Study:MECHANICAL POWER DAY (MPDay)
NCT03936231
Respiratory Mechanics in Intensive Care Patients
NCT03420417
Effects of Invasive Mechanical Ventilation on the Right Ventricular Function
NCT05710419
Respiratory Mechanics Measurement of Ventilated Patients Through Low-frequency Oscillometry Technique
NCT06483529
Measuring Energy Expenditure in ECMO (Extracorporeal Membrane Oxygenation) Patients
NCT01992237
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Mechanical energy monitoring
In the study subjects randomized into this arm, the value of mechanical energy will be monitored during mechanical ventilation.
Mechanical energy monitoring
Monitoring of the mechanical energy acting on the lung parenchyma during mechanical ventilation.
Conventional mechanical ventilation
Study subjects randomized into this arm will receive conventional mechanical ventilation, to the best of the physician's knowledge.
Conventional mechanical ventilation
The conventional procedure of mechanical ventilation controlled according to the physician's decision.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Mechanical energy monitoring
Monitoring of the mechanical energy acting on the lung parenchyma during mechanical ventilation.
Conventional mechanical ventilation
The conventional procedure of mechanical ventilation controlled according to the physician's decision.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* patients older than 18 years
* patients with lung disease (pneumonia, ARDS)
* expected duration of mechanical ventilation longer than 48 hours
Exclusion Criteria
* 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)
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University Hospital Ostrava
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Filip Burša, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Ostrava
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University Hospital Ostrava
Ostrava, Moravian-Silesian Region, Czechia
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Maca 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.
Acute 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.
Rittayamai 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.
Guerin 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.
Gattinoni 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.
de 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.
Nieman 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.
Gattinoni 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.
Cressoni 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.
Chiumello 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.
Giosa 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.
Becher 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.
Serpa 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.
Mietto 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.
Bursa F, Frelich M, Sklienka P, Kucerova Z, Sagan J, Oczka D, Penhaker M, Burda M, Maca J. Protective mechanical ventilation controlled by the real-time mechanical power measurement. J Clin Monit Comput. 2025 Oct 11. doi: 10.1007/s10877-025-01369-w. Online ahead of print.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
25/RVO-FNOs/2022
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.