Mechanical Power Normalized to Compliance in ARDS

NCT05761626 | Completed

• 1 other identifier: Universidad de Magallanes
• Study Type: observational
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Respiratory Distress Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  Third day of mechanical ventilation

Study Arms (2)

Patients with MP/Crs < = 0.48 j/min/ml/cmH2O

Patients with MP/Crs \< = 0.48 j/min/ml/cmH2O

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

Patients with MP/Crs > 0.48 j/min/ml/cmH2O

Patients with MP/Crs \> 0.48 j/min/ml/cmH2O

Interventions

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)

Patients with MP/Crs < = 0.48 j/min/ml/cmH2O

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ramos Mejía Hospital: lead

Study Sites (1)

Hospital Regional Rio Gallegos

Río Gallegos, Santa Cruz Province, 9400, Argentina

Location

Related Publications (9)

• 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

• 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.

  PMID: 36470747 BACKGROUND

• 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.

  PMID: 27637717 BACKGROUND

• 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.

  PMID: 31639025 BACKGROUND

• 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.

  PMID: 30291378 BACKGROUND

• 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.

  PMID: 19346233 BACKGROUND

• 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.

  PMID: 30211618 BACKGROUND

• 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.

  PMID: 32735841 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

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Design

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

Study Record Dates

• First Submitted: February 20, 2023
• First Posted: March 9, 2023
• Study Start: March 1, 2016
• Primary Completion: February 10, 2023
• Study Completion: February 10, 2023
• Last Updated: April 30, 2025

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1)