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Respiratory Distress Syndrome (RDS)NCT07171632

Components of Mechanical Power on the Functional Lung in ARDS

An observational study of Respiratory Distress Syndrome (RDS), run by Ramos Mejía Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Mechanical power (MP) is a composite variable that integrates static and dynamic respiratory parameters and has been associated with ventilator-induced lung injury (VILI). MP is predominantly delivered to the reduced functional lung size, commonly referred to as the "baby lung" (BL). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Respiratory Distress Syndrome (RDS)
What is being tested?
monitoring of clinical and ventilatory variables
How many people
184 participants
Where
No sites listed yet
Study dates
1 Dec 2025to 10 Mar 2027
Phase
Observational
Are there results?
Not yet: the study is under way

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

Study population: Patients ≥ 18 years with acute respiratory distress syndrome receiving invasive mechanical ventilation for at least 48 consecutive hours

Who may be able to join

  • Patients ≥ 18 years
  • Diagnosis of acute respiratory distress syndrome
  • Receiving invasive mechanical ventilation (volume control mode) for at least 48 consecutive hours.

Who cannot join

  • Patients spontaneously breathing
  • Patients under non-invasive support therapies
  • Patients receiving ventilation through a tracheostomy cannula at any time during the first 48 h
  • Patients that receiving pressure-controlled ventilation or any modality other than volume-controlled
  • Patients with missing data for calculating mechanical power (MP).
  • Patients with chronic pulmonary disease
  • 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

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Roberto Santa Cruz, PhD contact

+5492966559019

resc.hrrg@gmail.com

About this study

Official title: Assessment of Mechanical Power Components on the Functional Lung in Patients With Acute Respiratory Distress Syndrome (ARDS)

Mechanical power (MP) is a composite variable that integrates static and dynamic respiratory parameters and has been associated with ventilator-induced lung injury (VILI). MP is predominantly delivered to the reduced functional lung size, commonly referred to as the "baby lung" (BL). Functional lung size, in turn, is closely related to respiratory system compliance (Crs). Previous studies have demonstrated an association between MP normalized to compliance (MP/Crs) and mortality. Moreover, evidence suggests that VILI associated with MP/Crs results primarily from the combined effect of its components rather than from any single component in isolation.

The objective of this study is to evaluate both the overall and the relative contribution of each component of mechanical power, normalized to compliance (MP/Crs), to in-hospital mortality in patients with acute respiratory distress syndrome (ARDS).

Read the detailed description

In patients with acute respiratory distress syndrome (ARDS) who require mechanical ventilation (MV), each respiratory cycle transfers a quantifiable amount of mechanical energy to the lung. This energy is necessary both to expand the respiratory system and to overcome airway resistance. The total mechanical energy delivered per breath, when multiplied by the respiratory rate (RR), defines the concept of mechanical power (MP). From a pathophysiological perspective, MP is considered a key determinant of ventilator-induced lung injury (VILI), as it reflects the dynamic interaction of pressure, volume, and flow variables over time.

However, this transferred energy does not act uniformly throughout the lung. In ARDS, the functional portion of ventilated lung tissue is reduced due to edema, atelectasis, and consolidation. This remaining ventilatable lung volume is often referred to as the "baby lung" (BL). When mechanical energy is delivered to a smaller BL, the energy density (energy per unit of available tissue) increases, which may amplify local stress and strain, thereby exacerbating lung injury. Respiratory system compliance (Crs) has been widely used as a surrogate for BL size, given that lower compliance indicates a smaller proportion of functional lung available for ventilation.

Protective ventilation strategies, therefore, should aim not only to minimize the absolute amount of mechanical energy delivered but also to adapt it to the size of the BL in order to avoid excessive energy transfer and its potential for injury. For this reason, normalizing mechanical power to compliance (MP/Crs) has been proposed as a physiologically sound parameter, as it accounts for both the intensity of mechanical ventilation and the size of the lung that receives it.

Several studies have identified an association between MP/Crs and mortality in ARDS, supporting its role as a potential prognostic marker. Furthermore, emerging evidence suggests that the detrimental effect of MP/Crs on lung tissue is not explained by a single variable in isolation, but rather by the combined contribution of its components, including elastic dynamic power (related to driving pressure), resistive power (related to airflow resistance), and static elastic power (related to positive end-expiratory pressure). This highlights the need for a more granular evaluation of how each of these elements contributes to overall patient outcomes.

Therefore, to test the hypothesis that MP/Crs is independently associated with patient-centered outcomes in a well-characterized cohort of patients with ARDS, we will analyze detailed ventilatory parameters required for the calculation of mechanical power and its components. These data will be obtained from a prospectively collected cohort of intensive care unit (ICU) patients, allowing for accurate computation of MP/Crs and comprehensive evaluation of its relationship with clinically relevant outcomes.

Being tested
monitoring of clinical and ventilatory variables
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.

  • monitoring of clinical and ventilatory variablesOther

    Monitoring clinical data

Study groups in NCT07171632
Study groupRoleWhat they receive
SurvivorsSurvivors patients > 18 years on the third day of ARDS receiving invasive mechanical ventilation (volume control mode) for at least 48 consecutive hours.
Receives: Other: monitoring of clinical and ventilatory variables

What is being measured

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

  1. Mechanical Power normalized to compliance (MP/Crs) and in-hospital mortality

    Mechanical Power (MP) will be calculated using ventilator-derived parameters (tidal volume in mL, driving pressure in cmH₂O, inspiratory flow in L/s, and respiratory rate in breaths/min). This value will then be normalized to respiratory system compliance (Crs, in mL/cmH₂O) to obtain MP/Crs. The reported outcome will be a single aggregated measure, expressed in Joules per minute cmH2O (J/min/cmH2O), assessed on the third day of mechanical ventilation.

    Measured: MP/Crs: day 3. Mortality: from enrollment until hospital discharge.

Timeline

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

  1. First posted12 Sep 2025
  2. Study start1 Dec 2025 (estimated)
  3. Primary completion1 Dec 2026 (estimated)
  4. Study completion10 Mar 2027 (estimated)

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
184 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07171632
Sponsor's protocol ID
Escuela de Medicina, UMAG
Status last verified
Aug 2025
First submitted
24 Aug 2025
Last updated
4 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • ARDS Definition Task Force; Ranieri VM, Rubenfeld GD, Thompson BT, Ferguson ND, Caldwell E, Fan E, Camporota L, Slutsky AS. Acute respiratory distress syndrome: the Berlin Definition. JAMA. 2012 Jun 20;307(23):2526-33. doi: 10.1001/jama.2012.5669.

    PubMed 22797452
  • Santa Cruz R, Nadur J, Jara M, Navarrete M, Gagliardi J, Esquinas A, Marini JJ. Should Mechanical Power Be Normalized to Compliance? Respir Care. 2026 Jan;71(1):73-75. doi: 10.1177/19433654251360618. Epub 2026 Jan 13. No abstract available.

    PubMed 40711841
  • Vassalli F, Pasticci I, Romitti F, Duscio E, Assmann DJ, Grunhagen H, Vasques F, Bonifazi M, Busana M, Macri MM, Giosa L, Reupke V, Herrmann P, Hahn G, Leopardi O, Moerer O, Quintel M, Marini JJ, Gattinoni L. Does Iso-mechanical Power Lead to Iso-lung Damage?: An Experimental Study in a Porcine Model. Anesthesiology. 2020 May;132(5):1126-1137. doi: 10.1097/ALN.0000000000003189.

    PubMed 32032095
  • 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
  • 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
  • Coppola S, Caccioppola A, Froio S, Formenti P, De Giorgis V, Galanti V, Consonni D, Chiumello D. Effect of mechanical power on intensive care mortality in ARDS patients. Crit Care. 2020 May 24;24(1):246. doi: 10.1186/s13054-020-02963-x.

    PubMed 32448389
  • Chiu LC, Lin SW, Chuang LP, Li HH, Liu PH, Tsai FC, Chang CH, Hung CY, Lee CS, Leu SW, Hu HC, Huang CC, Wu HP, Kao KC. Mechanical power during extracorporeal membrane oxygenation and hospital mortality in patients with acute respiratory distress syndrome. Crit Care. 2021 Jan 6;25(1):13. doi: 10.1186/s13054-020-03428-x.

    PubMed 33407733
  • 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.

    PubMed 26781952
  • Dianti J, Matelski J, Tisminetzky M, Walkey AJ, Munshi L, Del Sorbo L, Fan E, Costa EL, Hodgson CL, Brochard L, Goligher EC. Comparing the Effects of Tidal Volume, Driving Pressure, and Mechanical Power on Mortality in Trials of Lung-Protective Mechanical Ventilation. Respir Care. 2021 Feb;66(2):221-227. doi: 10.4187/respcare.07876. Epub 2020 Aug 25.

    PubMed 32843513
  • 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.

    PubMed 27620287
  • 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 28899408

Questions about this trial

What is this clinical trial studying?

An observational study of Respiratory Distress Syndrome (RDS), run by Ramos Mejía Hospital.

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 3 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: opening soon, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

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?

This study is still under way. Results are not available in the source record yet.

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

Contact Roberto Santa Cruz, PhD (+5492966559019, resc.hrrg@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mechanical Power normalized to compliance (MP/Crs) and in-hospital mortality (time frame: MP/Crs: day 3. Mortality: from enrollment until hospital discharge.). 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 NCT07171632, which also lists 11 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 4 Dec 2025.

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