Components of Mechanical Power on the Functional Lung in ARDS

NCT ID: NCT07171632

Last Updated: 2025-12-04

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 184 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-12-01
• Study Completion Date: 2027-03-10

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).

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.

Conditions

Respiratory Distress Syndrome (RDS)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Survivors

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

monitoring of clinical and ventilatory variables

Intervention Type: OTHER

Monitoring clinical data

Interventions

monitoring of clinical and ventilatory variables

Monitoring clinical data

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad de la Republica

OTHER

Sponsor Role: collaborator

Ramos Mejía Hospital

OTHER

Sponsor Role: lead

Responsible Party

Roberto Santa Cruz

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Martin Angulo, PhD

Role: STUDY_CHAIR

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

Antonella Gómez, MD

Role: STUDY_DIRECTOR

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

Central Contacts

Roberto Santa Cruz, PhD

Role: CONTACT

resc.hrrg@gmail.com

+5492966559019

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Related Links

https://pubmed.ncbi.nlm.nih.gov/32032095/

Related Info

Other Identifiers

Escuela de Medicina, UMAG

Identifier Type: -

Identifier Source: org_study_id