Mechanical Ventilation in Patients With Lung Impairment Controlled by the Mechanical Energy of the Respiratory System

NCT06035146 | Unknown

• 1 other identifier: 25/RVO-FNOs/2022
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

ARDS; Lung Injury, Ventilator Induced

Keywords

mechanical ventilation; adult respiratory distress syndrome; ventilator-induced lung injury; mechanical energy

Outcome Measures

Primary Outcomes (1)

• The level of mechanical energy (in Joules/min)

  The level of mechanical energy will be measured (in Joules/min) in both study arms.

  up to 14 days

Secondary Outcomes (3)

• The number of days on mechanical ventilation

  up to 14 days

• The effect of mechanical energy on patient mortality

  up to 14 days

• The effect of mechanical energy on hospital mortality

  up to 8 weeks

Study Arms (2)

Mechanical energy monitoring

EXPERIMENTAL

In the study subjects randomized into this arm, the value of mechanical energy will be monitored during mechanical ventilation.

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.

Procedure: Conventional mechanical ventilation

Interventions

Mechanical energy monitoring PROCEDURE

Monitoring of the mechanical energy acting on the lung parenchyma during mechanical ventilation.

Mechanical energy monitoring

Conventional mechanical ventilation PROCEDURE

The conventional procedure of mechanical ventilation controlled according to the physician's decision.

Conventional mechanical ventilation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• pregnant women, when this fact is stated in the admission protocol

Sponsors & Collaborators

• University Hospital Ostrava: lead

Study Sites (1)

University Hospital Ostrava

Ostrava, Moravian-Silesian Region, 70852, Czechia

RECRUITING

Related Publications (16)

• 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.

  PMID: 27007111 BACKGROUND

• 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.

  PMID: 27803355 BACKGROUND

• 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.

  PMID: 10793162 BACKGROUND

• 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.

  PMID: 25726563 BACKGROUND

• 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.

  PMID: 27894328 BACKGROUND

• 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.

  PMID: 26781952 BACKGROUND

• 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.

  PMID: 21906379 BACKGROUND

• 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.

  PMID: 27316442 BACKGROUND

• 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.

  PMID: 27620287 BACKGROUND

• 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.

  PMID: 26872367 BACKGROUND

• 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.

  PMID: 32653011 BACKGROUND

• 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.

  PMID: 31773328 BACKGROUND

• 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.

  PMID: 31101961 BACKGROUND

• 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.

  PMID: 30291378 BACKGROUND

• 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.

  PMID: 26575165 BACKGROUND

• 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.

  PMID: 41075121 DERIVED

MeSH Terms

Conditions

Ventilator-Induced Lung Injury; Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Injury; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Filip Burša, MD,PhD

  University Hospital Ostrava

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiří Hynčica

CONTACT

0042059737; jiri.hyncica@fno.cz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No masking will be used in the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study subjects will be randomized into two parallel groups.

Study Record Dates

• First Submitted: February 15, 2023
• First Posted: September 13, 2023
• Study Start: August 1, 2022
• Primary Completion: July 31, 2025
• Study Completion: December 31, 2025
• Last Updated: September 13, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)