Respiratory Distress Syndrome, Adult Clinical Trial
Official title:
Strategies for Optimal Lung Ventilation in ECMO for ARDS: The SOLVE ARDS Study
Due to lack of studies on mechanical ventilation strategies in patients with severe Acute
Respiratory Distress Syndrome (ARDS) supported with Veno-Venous Extra-Corporeal Membrane
Oxygenation (VV ECMO), ventilator settings in this patient population are set arbitrarily.
In this two-phases prospective, interventional, pilot study we hope to gain physiologically
relevant data on two aspects of mechanical ventilation in patients with severe ARDS
supported with VV ECMO: (1) the use of tidal ventilation and (2) the level of Positive
End-Expiratory Pressure (PEEP).
1. PHASE 1: impact of tidal ventilation on VILI (10 patients) We hypothesized that a CPAP
strategy that minimizes end-tidal pulmonary stress and strain mitigates VILI compared
to the current mechanical ventilation practice that employs tidal ventilation in
patients with severe ARDS on ECMO.
In this first phase we will test whether administering a distending inspiratory
pressure to produce tidal ventilation is superior to a strategy where only continuous
positive airway pressure (CPAP) is applied for ventilation induced lung injury (VILI)
mitigation, as assessed by its impact on biotrauma (serum cytokines) and physiologic
measurements.
2. PHASE 2: impact of PEEP on VILI (10 patients) We also hypothesized that adjusting PEEP
to maximize respiratory system compliance reduces VILI in patients with severe ARDS on
ECMO.
In the second phase we will therefore gain more insight as to whether a strategy that
utilizes a PEEP level that correspond to best compliance is beneficial over Zero
End-Expiratory Pressure (ZEEP). We will test the impact of both strategies on biotrauma
(serum cytokines), physiologic parameters, and right ventricular function (transesophageal
echocardiographic assessment).
Because ARDS patients supported with VV ECMO can be hemodynamically unstable, the use of
imaging techniques that require transport, such as computed tomography, is limited.
Therefore, bedside imaging techniques, such as pleural and lung ultrasound (PLUS) and
focused bedside cardiac ultrasonography, are important tools for clinicians who care for
these patients. This study will allow us to learn whether these techniques are feasible and
valid in this patient population.
Furthermore, the knowledge gained from this study will allow us to assess the rationale and
feasibility of performing a similar larger, randomized study in the future.
n/a
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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