Mechanical Power Normalized to Compliance in ARDS

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

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.

Study Overview

• Status: Completed
• Conditions: Acute Respiratory Distress Syndrome
• Intervention / Treatment: Other: MP/Crs assessment < = 0.48 J/min/ml/cmH2O

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 Type: Observational
• Enrollment (Actual): 39

Contacts and Locations

Study Locations

• Argentina
  • Santa Cruz
    • Rio Gallegos, Santa Cruz, Argentina, 9400
      • Hospital Regional Rio Gallegos

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with MP/Crs < = 0.48 j/min/ml/cmH2O	Other: MP/Crs assessment < = 0.48 J/min/ml/cmH2O; Assessment of the ventilatory variables according to the MP/Crs value (<= or > 0.48 J/min/ml/cmH2O)
Patients with MP/Crs > 0.48 j/min/ml/cmH2O

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Ramos Mejía Hospital

Publications and helpful links

General Publications

• 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.
• Sinha P, Calfee CS, Beitler JR, Soni N, Ho K, Matthay MA, Kallet RH. Physiologic Analysis and Clinical Performance of the Ventilatory Ratio in Acute Respiratory Distress Syndrome. Am J Respir Crit Care Med. 2019 Feb 1;199(3):333-341. doi: 10.1164/rccm.201804-0692OC.
• Marini JJ, Jaber S. Dynamic predictors of VILI risk: beyond the driving pressure. Intensive Care Med. 2016 Oct;42(10):1597-1600. doi: 10.1007/s00134-016-4534-x. Epub 2016 Sep 16. No abstract available.
• Marini JJ. How I optimize power to avoid VILI. Crit Care. 2019 Oct 21;23(1):326. doi: 10.1186/s13054-019-2638-8. No abstract available.
• Serpa Neto A, Deliberato RO, Johnson AEW, Bos LD, Amorim P, Pereira SM, Cazati DC, Cordioli RL, Correa TD, Pollard TJ, Schettino GPP, Timenetsky KT, Celi LA, Pelosi P, Gama de Abreu M, Schultz MJ; PROVE Network Investigators. Mechanical power of ventilation is associated with mortality in critically ill patients: an analysis of patients in two observational cohorts. Intensive Care Med. 2018 Nov;44(11):1914-1922. doi: 10.1007/s00134-018-5375-6. Epub 2018 Oct 5.
• Sinha P, Fauvel NJ, Singh S, Soni N. Ventilatory ratio: a simple bedside measure of ventilation. Br J Anaesth. 2009 May;102(5):692-7. doi: 10.1093/bja/aep054. Epub 2009 Apr 3.
• Urner M, Juni P, Hansen B, Wettstein MS, Ferguson ND, Fan E. Time-varying intensity of mechanical ventilation and mortality in patients with acute respiratory failure: a registry-based, prospective cohort study. Lancet Respir Med. 2020 Sep;8(9):905-913. doi: 10.1016/S2213-2600(20)30325-8. Epub 2020 Jul 28.
• 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.
• Maj R, Palermo P, Gattarello S, Brusatori S, D'Albo R, Zinnato C, Velati M, Romitti F, Busana M, Wieditz J, Herrmann P, Moerer O, Quintel M, Meissner K, Sanderson B, Chiumello D, Marini JJ, Camporota L, Gattinoni L. Ventilatory ratio, dead space, and venous admixture in patients with acute respiratory distress syndrome. Br J Anaesth. 2023 Mar;130(3):360-367. doi: 10.1016/j.bja.2022.10.035. Epub 2022 Dec 2.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2016
• Primary Completion (Actual): February 10, 2023
• Study Completion (Actual): February 10, 2023

Study Registration Dates

• First Submitted: February 20, 2023
• First Submitted That Met QC Criteria: February 27, 2023
• First Posted (Actual): March 9, 2023

Study Record Updates

• Last Update Posted (Actual): April 30, 2025
• Last Update Submitted That Met QC Criteria: April 24, 2025
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease; Lung Diseases; Respiration Disorders; Infant, Premature, Diseases; Infant, Newborn, Diseases; Lung Injury; Syndrome; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• Other Study ID Numbers: Universidad de Magallanes

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The data will be uploaded in an Excel document and shared with all the researchers participating in the study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No