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OpenTrials
Completed

NCT Number: NCT05761626

Mechanical Power Normalized to Compliance in ARDS

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.

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Key information

Age range

15 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Regional Rio Gallegos

Río Gallegos, Santa Cruz Province, 9400, Argentina

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MP/Crs assessment < = 0.48 J/min/ml/cmH2O

Other

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

Primary outcomes

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

    Time frame: Third day of mechanical ventilation

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

Secondary outcomes

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ramos Mejía Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2023
Study completion
2023
First posted
Mar 9, 2023
Registry last updated
Apr 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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