Specific Mechanical Power Assessment in Patients With Acute Respiratory Distress Syndrome

Sponsor
Hospital El Cruce (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05410262
Collaborator
(none)
20
6

Study Details

Study Description

Brief Summary

In ARDS patients, mechanical ventilation should minimize ventilator-induced lung injury. The mechanical power which is the energy per unit time released to the respiratory system according to the applied tidal volume, PEEP, respiratory rate, and flow should reflect the ventilator-induced lung injury

Condition or Disease Intervention/Treatment Phase
  • Other: Evaluation of CT images

Detailed Description

Mechanical ventilation is an essential tool for the treatment of patients with acute respiratory distress syndrome (ARDS); however, as other strategies, it is not free of complications. Inadequate ventilation may have a negative impact on the lung that may eventually cause the development of multiple organ failure and death. This process is known as ventilator-induced lung injury (VILI). From a clinical perspective, one of the most important objectives of ARDS treatment is to avoid or mitigate the development of VILI, not only to preserve pulmonary integrity, but also to reduce mortality.

Ventilator-induced lung injury results from the interaction between the mechanical load applied to the lung and its capacity to tolerate it. Factors such as tidal volume (Vt), plateau pressure (PPlat), lung strain or insufflation pressure (ΔP), inspiratory flow rate (VI), respiratory rate (RR), excessive inspiratory effort, high levels of FiO2 and high levels of positive end-expiratory pressure (PEEP), have been directly involved in damage mechanism. With an integrating and rheological idea, the concept of mechanical power tries to encompass the majority of these factors within a measurable unit in joules per minute, as the expression of power applied on a repetitive basis on the respiratory system in ARDS. Although the concept of MP holds promise for preventing the risk of VILI, its utility has not been proven in clinical practice until now. The main value of MP over the rest of commonly used variables for the monitoring of patients with ARDS is that it includes flow on injury mechanism (kinetic energy), accepting that an inverse relationship exists between this mechanism and the capacity of alveoli to adapt to change during the ventilation cycle (strain rate), as well as it embodies the concept of process repeatability (respiratory rate), though not of its duration. This begs the question whether we should consider its value at the moment of defining a mechanical ventilation strategy. The main disadvantage of its application is that MP conceives the respiratory system in an integrated manner and not related to or standardized with the ventilable lung portion, that is ultimately the one who has to withstand the ventilatory load; in other words, the same MP may have different consequences depending on the baby lung size or its equivalent, the severity of ARDS.

The objective of this study is to evaluate the influence of the ventilable lung size on VILI mechanisms in patients suffering from ARDS treated with protective ventilation with similar MP.

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
20 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Specific Mechanical Power Assessment in Patients With Acute Respiratory Distress Syndrome
Anticipated Study Start Date :
Jul 1, 2022
Anticipated Primary Completion Date :
Nov 30, 2022
Anticipated Study Completion Date :
Dec 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Mechanical power and risk of ventilator-induced lung injury in patients with ARDS

This study will prospectively evaluate patients consecutively admitted with ARDS, as defined according to the Berlin expert consensus

Other: Evaluation of CT images
A helicoidal CT scanner will be used (Aquilion CXL, Toshiba, Japan), with AIDR 3D technique (Adaptive Iterative Dose Reduction 3D) in order to minimize exposure to X-rays. Two complete thorax CT scans will be performed, one of them in expiratory pause (PEEP) and the other in inspiratory pause (PPlat). Esophageal pressure shall be measured (FluxMed GrT, Argentina) and transpulmonary pressure will be calculated at the end of inspiration (Ppl-insp) and expiration (Ppl-exp).
Other Names:
  • Evaluation of transpulmonary pressures
  • Outcome Measures

    Primary Outcome Measures

    1. specific mechanical power ["immediately after the intervention/procedure/surgery"]

      Specific mechanical power was calculated as the ratio of mechanical power to ventilable lung volume.

    2. relationship between lung load and severity of ARDS ["immediately after the intervention/procedure/surgery"]

      relationship between specific mechanical power and severity of ARDS

    3. relationship between lung load and elastance of ARDS ["immediately after the intervention/procedure/surgery"]

      relationship between specific mechanical power and elastance of ARDS

    4. relationship between lung load and strain ["immediately after the intervention/procedure/surgery"]

      relationship between specific mechanical power and strain

    5. relationship between lung load and atelectrauma ["immediately after the intervention/procedure/surgery"]

      relationship between specific mechanical power and atelectrauma

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    Inclusion Criteria: patients consecutively admitted with ARDS -

    Exclusion Criteria: Patients who meet any of the following criteria: history of emphysema, asthma, pneumothorax or bronchopleural fistula. Severe instability condition at the time of the study: SaO2 ≤90%, shock requiring noradrenaline ≥0,5 γ/kg/min, ventricular arrhythmia, myocardial ischemia and endocranial hypertension. Esophageal pathology that contraindicates esophageal balloon placement. Severe coagulopathy (platelet count <20000/mm3 or INR >4). Inability to undergo CT imaging: morbid obesity (≥170 kg) or abdominal girth >200 cm. Patients with do-not-resuscitate (DNR) orders, pregnant women and those who participated in other research studies within the last 30 days.

    -

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Hospital El Cruce

    Investigators

    • Principal Investigator: Nestor Pistillo, Hospital El Cruce

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Nestor Pistillo, Head of Intensive Care Unit al Hospital El Cruce, Hospital El Cruce
    ClinicalTrials.gov Identifier:
    NCT05410262
    Other Study ID Numbers:
    • El Cruce
    First Posted:
    Jun 8, 2022
    Last Update Posted:
    Jun 8, 2022
    Last Verified:
    Jun 1, 2022
    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
    Keywords provided by Nestor Pistillo, Head of Intensive Care Unit al Hospital El Cruce, Hospital El Cruce
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 8, 2022