Mechanical Power Normalized to Compliance in ARDS

NCT ID: NCT05761626

Last Updated: 2025-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

39 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-03-01

Study Completion Date

2023-02-10

Brief Summary

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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

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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.

Conditions

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Acute Respiratory Distress Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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

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

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

Intervention Type 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

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

No interventions assigned to this group

Interventions

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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)

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ramos Mejía Hospital

OTHER

Sponsor Role lead

Responsible Party

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Roberto Santa Cruz

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hospital Regional Rio Gallegos

Río Gallegos, Santa Cruz Province, Argentina

Site Status

Countries

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Argentina

References

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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.

Reference Type BACKGROUND
PMID: 26872367 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36470747 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27637717 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31639025 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30291378 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19346233 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30211618 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32735841 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31062050 (View on PubMed)

Other Identifiers

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Universidad de Magallanes

Identifier Type: -

Identifier Source: org_study_id

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