PRONing to Facilitate Weaning From ECMO in Patients With Refractory Acute Respiratory Distress Syndrome
Condition: ARDS
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
Study type: Interventional

Summary: 
      ECMO has emerged as a promising intervention that may provide more efficacious supportive
      care to patients with refractory severe acute respiratory distress syndrome (ARDS). The
      largest randomized trial of ECMO for severe forms of ARDS was recently published and
      demonstrated no significant benefit from early initiation of ECMO with respect to 60-day
      mortality, when compared with a strategy of conventional mechanical ventilation (MV) (ref
      EOLIA). However, a rescue ECMO option was used by 28% of the controls, which is likely to
      have diluted the potential positive effect of ECMO. One may argue that a less restrictive
      primary endpoint, such as death or rescue ECMO, would have yielded positive findings.

      Meanwhile, improvements in technology have made ECMO safer and easier to use, allowing for
      the potential of more widespread application in patients with ARDS. VV-ECMO can be used as a
      life-saving rescue therapy in patients with ARDS when MV cannot maintain adequate oxygenation
      or CO2 elimination. Alternatively, VV-ECMO may be used in patients who remain hypoxemic
      during MV (i.e., PaO2/FiO2<80 mmHg) despite optimization of MV (including the application of
      high levels of positive end-expiratory pressure (PEEP), neuromuscular blockers, and prone
      positioning) and allow "lung rest" by lowering airway pressures and tidal volume to
      ameliorate ventilator-induced lung injury (VILI).

      Prone positioning (PP) has been used for more than 30 years in patients with acute hypoxemic
      respiratory failure and in particular with ARDS. Initially, PP in ARDS patients was proposed
      as an efficient mean to improve oxygenation, sometimes dramatically, in a large number of
      patients. In addition, it is now clear, and data are still accumulating, that PP is also able
      to prevent VILI which is as important as maintaining safe gas exchange in mechanical
      ventilation. Therefore, PP is a strategy that covers the two major goals of ventilator
      support in ARDS patients, maintaining safe oxygenation and preventing VILI and reducing
      mortality at the end. This latter objective makes sense on ECMO as one of the main objective
      of this device is to markedly reduce VILI by resting the lung.

      Considering that PP is a valuable and safe therapy to reduce VILI, its combination with ECMO
      could enhance VILI prevention. In recent preliminary studies, it was reported that the
      combination of VV-ECMO and PP was associated with a dramatic improvement in oxygenation, in
      pulmonary and thoracic compliance and in chest X-ray findings. It may thus facilitate the
      weaning of ECMO and can be performed without compromising the safety of the patients. Lung
      recruitment and improvement in ventilation/perfusion mismatch on prone position may both
      contribute to improve oxygenation. PP may therefore be efficient to hasten the weaning of
      VV-ECMO when atelectasis and ventilation/perfusion mismatch occur under ultra-protective
      ventilation even in patients in whom pre-ECMO PP failed. In addition, it could also enhance
      ventilator induced lung injury prevention on ECMO.
    


Intervention name(s): Prone positionning; Supine position
Intervention type(s): Procedure; Procedure
Intervention description(s): 4 to 5 persons required for the procedure, one of them being dedicated to the management of the head of the patient, the endotracheal tube, the jugular ECMO cannula and the ventilator lines and another dedicated to the femoral ECMO cannula. The person at the head of the bed will coordinate the steps. The other persons will stand at each side of the bed. The direction of the rotation will be decided giving priority to the side of the central venous lines. The length of vascular and ventilator lines will be checked for appropriateness, the endotracheal tube and gastric tube will be secured, and the patient's knees, forehead, chest, and iliac crests will be protected using adhesive pads. The patient will be then moved along the horizontal plane to the opposite side of the bed selected for the direction of rotation. Patients will be proned at least four times during the first days on ECMO. Each prone session will stand for at least 16 hours; Patients assigned to supine will remain in a semi-recumbent position.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: ECMO Weaning; PRONING