Mechanical Power Normalized to Compliance in ARDS

Completed

• Conditions: Acute Respiratory Distress Syndrome

• Registration Number: NCT05761626
• Lead Sponsor: Ramos Mejía Hospital

Brief 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). 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.

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.

Study Timeline

• Study Start: 2016-03-01
• Primary Completion: 2023-02-10
• Study Completion: 2023-02-10
• Study First Submitted: 2023-02-20
• Study First Submitted QC: 2023-02-27
• Status Verified: 2023-03
• Study First Posted: 2023-03-09
• Last Update Submitted: 2025-04-24
• Last Update Posted: 2025-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

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

Exclusion Criteria

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare variables according to the MP/Crs (J/min/ml/cmH2O) cut-off point	Third day of mechanical ventilation	MP/Crs (J/min/ml/cmH2O) will be used to establish the cut-off and compare variables.

Secondary Outcome Measures

Name	Time	Method
Components of MP associated with MP/Crs (J/min/ml/cmH2O)	Third day of mechanical ventilation	Through a multivariate analysis, the association between MP/Crs (J/min/ml/cmH2O) and the components of MP will be assessed.

Trial Locations

Locations (1)

Hospital Regional Rio Gallegos; 🇦🇷 Rio Gallegos, Santa Cruz, Argentina