Components of Mechanical Power on the Functional Lung in ARDS

NCT07171632 | Not Yet Recruiting

• 1 other identifier: Escuela de Medicina, UMAG
• Study Type: observational
• Target: 184
• Locations: 0 countries
• Sites: N/A

Brief 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). 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).

Conditions

Respiratory Distress Syndrome (RDS)

Outcome Measures

Primary Outcomes (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.

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

Study Arms (1)

Survivors

Survivors patients \> 18 years on the third day of ARDS receiving invasive mechanical ventilation (volume control mode) for at least 48 consecutive hours.

Other: monitoring of clinical and ventilatory variables

Interventions

monitoring of clinical and ventilatory variables OTHER

Monitoring clinical data

Survivors

Eligibility Criteria

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

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ramos Mejía Hospital: lead
• Universidad de la Republica: collaborator

Related Publications (11)

• 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.

  PMID: 22797452 BACKGROUND

• 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.

  PMID: 40711841 BACKGROUND

• 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.

  PMID: 32032095 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

• 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.

  PMID: 31062050 BACKGROUND

• 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.

  PMID: 32448389 BACKGROUND

• 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.

  PMID: 33407733 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

• 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.

  PMID: 32843513 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

• 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.

  PMID: 28899408 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Martin Angulo, PhD

  Hospital de Clínicas "Dr. Manuel Quintela" Faculty of Medicine, Universidad de la República (Udelar) Montevideo, Uruguay

  STUDY CHAIR

• Antonella Gómez, MD

  Hospital de Clínicas "Dr. Manuel Quintela" Faculty of Medicine, Universidad de la República (Udelar) Montevideo, Uruguay

  STUDY DIRECTOR

Central Study Contacts

Roberto Santa Cruz, PhD

CONTACT

+5492966559019; resc.hrrg@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: August 24, 2025
• First Posted: September 12, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 10, 2027
• Last Updated: December 4, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share