Mechanical Power and Ventilatory Ratio in ARDS

Sponsor
Ramos Mejía Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05761626
Collaborator
(none)
39
1
83.4
0.5

Study Details

Study Description

Brief Summary

Mechanical power (MP) and ventilatory ratio (VR) are variables associated with outcomes in patients with acute respiratory distress syndrome (ARDS). In respiratory setting, the optimization of MP should lead to an increase in VR. Therefore, the objectives of this study are: to assess the relationship between MP and VR and to compare the components of MP (ventilatory variables) according to a level of MP (17 J/minute) considered harmful.

Condition or Disease Intervention/Treatment Phase
  • Other: MP < 17 J/min

Detailed Description

In patients with acute respiratory distress syndrome (ARDS), mechanical ventilation is a life support therapy; however, its use is associated with ventilator-induced lung injury (VILI). VILI is the final manifestation of changes in lung mechanics that occurs in each ventilatory cycle in a damaged lung parenchyma. In each respiratory cycle, a certain amount of mechanical energy is transferred to the lung, which is used primarily to overcome airway resistance and expand the chest wall.This mechanical energy multiplied by the respiratory rate (RR) is what is known as mechanical power (MP), which reflects the amount of energy applied to the respiratory system per minute during mechanical ventilation (MV). The amount of energy transferred from the ventilator to the patient is measured in joules (J), while MP is defined as the amount of energy transferred per unit of time (J/minute). MP is a summary variable that includes: tidal volume (TV), RR, flow, positive end-expiratory pressure (PEEP) and driving pressure (difference between plateau pressure and PEEP). An experimental study showed that the increase in MP, through the increase in RR, was associated with VILI. There is also evidence that MP can predict the risk of mortality in mechanically ventilated patients with and without ARDS. In addition, a constant increase in the risk of death has been found with MP greater than 17.0 J/min. In turn, since this value could vary according to lung size, it has been proposed that MP normalized to lung size (assessed through lung compliance) may have better performance. One way to optimize the MP would be to limit the RR and TV. However, the decrease in any of these ventilatory variables can lead to inefficient ventilation and an increase in the arterial pressure of carbon dioxide (PaCO2). In recent years, the ventilatory ratio (VR) has been assessed. VR is a unitless ratio that it can be easily calculated using routine bedside variables. Its value reflects the ability of the lungs to excrete CO2 adequately. Higher values of VR were associated with higher pulmonary dead space and with mortality. In the ventilatory setting, the optimization of MP would lead to an increase in VR.In addition, and since the components of MP contribute unequally to its value, it would be important to be able to establish the variables that could be decisive in the ventilatory setting. For this reason, the primary outcome is to assess the relationship between PM and VR. The secondary outcomes are: to estimate the relationship between PM in relation to static compliance (PM/C) and VR, and to assess the differences in respiratory variables considering a MP of 17 J/min as cut-off point.

Study Design

Study Type:
Observational
Actual Enrollment :
39 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Relation Between Mechanical Power and Ventilatory Ratio in Patients With Acute Respiratory Distress Syndrome
Actual Study Start Date :
Mar 1, 2016
Actual Primary Completion Date :
Feb 10, 2023
Actual Study Completion Date :
Feb 10, 2023

Arms and Interventions

Arm Intervention/Treatment
Patients with MP < 17 j/min

Patients with acute respiratory distress syndrome with MP < 17 j/min

Patients with MP ≥ 17 j/min

Patients with acute respiratory distress syndrome with MP ≥ 17 j/min

Other: MP < 17 J/min
assessment of the ventilatory variables according to the MP value (< or >= 17 J/min)
Other Names:
  • MP >= 17 J/min
  • Outcome Measures

    Primary Outcome Measures

    1. To determine the correlation between mechanical power (MP) and ventilatory rate (VR) [3rd day of mechanical ventilation]

      The relationship (correlation) between MP and VR will be assessed, according to the value of both variables on day 3 of mechanical ventilation.

    Secondary Outcome Measures

    1. To determine the correlation between mechanical power (MP) and static compliance (SC) with ventilatory rate (VR). (MP/SC)/VR [3rd day of mechanical ventilation]

      The relationship (correlation) between mechanical power (MP) and static compliance (SC) with ventilatory rate (VR) will be assessed, according to the value of both variables on day 3 of mechanical ventilation.

    2. Assess the behavior of the ventilatory variables according to the MP value (> or < 17 j/min) [3rd day of mechanical ventilation]

      The ventilatory variables will be compared according to the MP value (< or >= 17 J/min)

    3. Assess the hydric balance according to the MP value (> or < 17 j/min) [3rd day of mechanical ventilation]

      The hydric balance will be compared according to the MP value (< or >= 17 J/min)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    15 Years and Older
    Sexes Eligible for Study:
    All
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital Regional Rio Gallegos Rio Gallegos Santa Cruz Argentina 9400

    Sponsors and Collaborators

    • Ramos Mejía Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Roberto Santa Cruz, Principal Investigator, Ramos Mejía Hospital
    ClinicalTrials.gov Identifier:
    NCT05761626
    Other Study ID Numbers:
    • Universidad de Magallanes
    First Posted:
    Mar 9, 2023
    Last Update Posted:
    Mar 10, 2023
    Last Verified:
    Mar 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 10, 2023