Prone Positioning and Abdominal Binding on Lung and Muscle Protection in ARDS Patients During Spontaneous Breathing

Online since 1 January 2024, updated 60 days ago

About this trial

Ventilator-induced diaphragmatic dysfunction and intensive care unit (ICU)-acquired weakness are two consequences of prolonged mechanical ventilation and critical illness in patients with acute respir...

Included participants

Gender
All
Age
≥ 18 years
Injury level
Level not specified
  • Severity (AIS)?
  • Time since injury
    All
    Healthy volunteers
    No
    Level not specified

    What’s involved

    Type

    Observational

    Details

    Study protocol will have three steps. The first step is a multimodal description to characterize ICU acquired weakness and ventilator-induced diaphragm dysfunction in prolonged mechanically ventilated ARDS patients at spontaneous breathing onset. The second step is a crossover clinical trial to test different ventilatory approaches oriented to improve physiological variables related to lung injury and diaphragm performance. The third step is a randomized controlled trial to test the effect of the previous ventilatory approaches on lung inflammatory response and biomarkers of lung and muscular injury. FIRST PHASE: A multimodal physiological description will be performed in assist-control ventilation at spontaneous breathing onset. At the study entry, the assessments will include conventional electromyography; electrical activity of the diaphragm; ultrasound of respiratory and non-respiratory muscles; respiratory flow; tidal volume; airway, esophageal and gastric pressures; and hemodynamic and electric impedance tomography monitoring at the end of 2-hours of spontaneous breathing period. SECOND PHASE: After the multimodal physiological description, a controlled randomized crossover trial will assign patients to three strategies of 2-hours period on assisted pressure-controlled ventilation mode: A.- Control group: supine at 45º, B.- Abdominal binding: supine at 45º plus abdominal binding, C.- Prone positioning (without abdominal banding). These strategies will be performed under standard positive end-expiratory pressure (PEEP) (ARDSNet strategy) and individualized PEEP (obtained at the lowest combination of collapse and overdistension according to electrical impedance tomography), applied in random order. Therefore, each patient will receive the six approaches, with washout periods of 15-minutes in assisted/controlled ventilation. THIRD PHASE: The day next to the crossover trial, each patient will be randomized to one of the three ventilatory strategies previously defined, A.- Control group: supine at 45º, B.- Abdominal binding: supine at 45º plus abdominal binding, C.- Prone positioning. These three strategies will be applied under standard PEEP (ARDSNet strategy). Between crossover and pilot randomized controlled trial, the patients will remain under moderate sedation in assisted pressure-controlled ventilation mode receiving an individualized PEEP level.

    Potential benefits

    Good to know: Potential benefits are defined as outcomes that are being measured during and/or after the trial.

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    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 6 Dec 2023
    • Organisation
    • University of Chile
    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 6 Dec 2023
    • Organisation
    • University of Chile

    Wings for Life supports SCITrialsFinder

    Wings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.

    Learn more