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Acute Respiratory Distress SyndromeNCT05761626

Mechanical Power Normalized to Compliance in ARDS

An observational study of Acute Respiratory Distress Syndrome, run by Ramos Mejía Hospital at 1 site in Argentina.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Mechanical power (MP) is a summary variable, which includes static and dynamic respiratory parameters, is associated with ventilator-induced lung injury. MP is transferred primarily to smaller functional lung size, often referred to as "baby lung" (BL). Read more about this study

Who is it for?
Ages 15 years and older
Conditions the study is for
Acute Respiratory Distress Syndrome
What is being tested?
MP/Crs assessment < = 0.48 J/min/ml/cmH2O
How many people
39 participants
Where
1 siteArgentina
Study dates
1 Mar 2016to 10 Feb 2023
Phase
Observational
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 15 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Patients who have been receiving mechanical ventilation (MV) and have been defined as with ARDS according to the Berlin definition

Who may be able to join

  • patients who have been receiving mechanical ventilation (MV) and have been defined as with ARDS according to the Berlin definition

Who cannot join

  • patients with chronic pulmonary disease
  • patients with an expected duration of MV shorter than 48 h
  • patients with a high risk of death within 3 months for reasons other than ARDS
  • patients having made the decision to withhold life-sustaining treatment.

Trial locations and contacts

1 site in 1 country.

Argentina1 site

  • Hospital Regional Rio Gallegos

    Río Gallegos, Santa Cruz Province, 9400

Other trials in Argentina

About this study

Official title: Mechanical Power Normalized to Compliance in Patients With Acute Respiratory Distress Syndrome

Mechanical power (MP) is a summary variable, which includes static and dynamic respiratory parameters, is associated with ventilator-induced lung injury. MP is transferred primarily to smaller functional lung size, often referred to as "baby lung" (BL). Functional lung size (BL) is associated with respiratory system compliance (Crs). For this reason, MP normalized to Crs (MP/Crs) could be an important parameter to evaluate. The objectives of this study were to compare variables according to the MP/Crs cut-off point and to identify the MP components associated with MP/Crs.

Read the detailed description

In patients with acute respiratory distress syndrome (ARDS), undergoing mechanical ventilation (MV), each respiratory cycle transfers a specific amount of mechanical energy to the lung, aimed to expand and overcome airway resistance. The total mechanical energy multiplied by the respiratory rate (RR) defines the mechanical power (MP). It has been hypothesized that a smaller functional lung size, often referred to as "baby lung" (BL), increases mechanical energy transfer that exacerbates lung damage. Functional lung size (BL) is associated with respiratory system compliance (Crs). Whatever the size of this operational BL, protective ventilation strategies should be aimed at preserving its size and functionality, to avoid ventilator-induced lung injury (VILI). For this reason, MP normalized to Crs (MP/Crs) could be an important parameter to evaluate. Preclinical studies have found that VILI arises primarily from a combination of MP components and not from any of its components individually. We believe that MP/Crs should have the same behavior in relation to MP components as a whole. Therefore, the objectives of this study are to compare variables according to the MP/Crs cut-off point and to identify the MP components associated with MP/Crs.

Being tested
MP/Crs assessment < = 0.48 J/min/ml/cmH2O
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.

  • MP/Crs assessment < = 0.48 J/min/ml/cmH2OOther

    Assessment of the ventilatory variables according to the MP/Crs value (<= or > 0.48 J/min/ml/cmH2O)

Study groups in NCT05761626
Study groupRoleWhat they receive
Patients with MP/Crs < = 0.48 j/min/ml/cmH2OPatients with MP/Crs < = 0.48 j/min/ml/cmH2O
Receives: Other: MP/Crs assessment < = 0.48 J/min/ml/cmH2O
Patients with MP/Crs > 0.48 j/min/ml/cmH2OPatients with MP/Crs > 0.48 j/min/ml/cmH2O

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To compare variables according to the MP/Crs (J/min/ml/cmH2O) cut-off point

    MP/Crs (J/min/ml/cmH2O) will be used to establish the cut-off and compare variables.

    Measured: Third day of mechanical ventilation

Secondary outcomes (1)

  1. Components of MP associated with MP/Crs (J/min/ml/cmH2O)

    Through a multivariate analysis, the association between MP/Crs (J/min/ml/cmH2O) and the components of MP will be assessed.

    Measured: Third day of mechanical ventilation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Mar 2023
  2. Study start1 Mar 2016
  3. Primary completion10 Feb 2023
  4. Study completion10 Feb 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05761626
Sponsor's protocol ID
Universidad de Magallanes
Status last verified
Mar 2023
First submitted
20 Feb 2023
Last updated
30 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The data will be uploaded in an Excel document and shared with all the researchers participating in the study.

Publications

  • 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.

    PubMed 26872367

  • Maj R, Palermo P, Gattarello S, Brusatori S, D'Albo R, Zinnato C, Velati M, Romitti F, Busana M, Wieditz J, Herrmann P, Moerer O, Quintel M, Meissner K, Sanderson B, Chiumello D, Marini JJ, Camporota L, Gattinoni L. Ventilatory ratio, dead space, and venous admixture in patients with acute respiratory distress syndrome. Br J Anaesth. 2023 Mar;130(3):360-367. doi: 10.1016/j.bja.2022.10.035. Epub 2022 Dec 2.

    PubMed 36470747

  • Marini JJ, Jaber S. Dynamic predictors of VILI risk: beyond the driving pressure. Intensive Care Med. 2016 Oct;42(10):1597-1600. doi: 10.1007/s00134-016-4534-x. Epub 2016 Sep 16. No abstract available.

    PubMed 27637717

  • Marini JJ. How I optimize power to avoid VILI. Crit Care. 2019 Oct 21;23(1):326. doi: 10.1186/s13054-019-2638-8. No abstract available.

    PubMed 31639025

  • 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.

    PubMed 30291378

  • Sinha P, Fauvel NJ, Singh S, Soni N. Ventilatory ratio: a simple bedside measure of ventilation. Br J Anaesth. 2009 May;102(5):692-7. doi: 10.1093/bja/aep054. Epub 2009 Apr 3.

    PubMed 19346233

  • Sinha P, Calfee CS, Beitler JR, Soni N, Ho K, Matthay MA, Kallet RH. Physiologic Analysis and Clinical Performance of the Ventilatory Ratio in Acute Respiratory Distress Syndrome. Am J Respir Crit Care Med. 2019 Feb 1;199(3):333-341. doi: 10.1164/rccm.201804-0692OC.

    PubMed 30211618

  • Urner M, Juni P, Hansen B, Wettstein MS, Ferguson ND, Fan E. Time-varying intensity of mechanical ventilation and mortality in patients with acute respiratory failure: a registry-based, prospective cohort study. Lancet Respir Med. 2020 Sep;8(9):905-913. doi: 10.1016/S2213-2600(20)30325-8. Epub 2020 Jul 28.

    PubMed 32735841

  • Zhang Z, Zheng B, Liu N, Ge H, Hong Y. Mechanical power normalized to predicted body weight as a predictor of mortality in patients with acute respiratory distress syndrome. Intensive Care Med. 2019 Jun;45(6):856-864. doi: 10.1007/s00134-019-05627-9. Epub 2019 May 6.

    PubMed 31062050

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Respiratory Distress Syndrome, run by Ramos Mejía Hospital at 1 site in Argentina.

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 1 inclusion and 4 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: finished, as of the sponsor's last update on 30 Apr 2025. 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 Argentina. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To compare variables according to the MP/Crs (J/min/ml/cmH2O) cut-off point (time frame: Third day of mechanical ventilation). 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 NCT05761626, which also lists 9 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 30 Apr 2025.

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