NCT05198986

Pronation During Veno-venous Extra Corporeal Membrane Oxygenation

Effects of Pronation on Respiratory System Mechanical Properties and Ventilation in Patients With Acute Respiratory Distress Syndrome During Vv-ecmo

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 15 (estimated)
• Sponsor: University Magna Graecia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The Acute Respiratory Distress Syndrome (ARDS) is defined by a recent (within 1 week) respiratory failure, not fully explained by cardiac failure or fluid overload. ARDS is also characterized by bilateral opacities at the chest imaging, with an alteration of the oxygenation while positive end-expiratory pressure equal or greater than 5 cmH2O is applied. Severe ARDS is characterized by a high mortality. In the most severe ARDS patients, venovenous extracorporeal membrane oxygenation (vv-ECMO) is increasingly accepted as a mean to support vital function, although not free from complications. In patients with severe ARDS, prone position has been used for many years to improve oxygenation. In these patients, early application of prolonged (16 hours) prone-positioning sessions significantly decreased 28-day and 90-day mortality. More recently, prone position and ECMO have been coupled as concurrent treatment. Indeed, the addition of prone positioning therapy concurrently with ECMO can aid in optimizing alveolar recruitment, and reducing ventilator-induced lung injury. Nowadays, few data exist on respiratory mechanics modifications before and after the application of prone position in patients with severe ARDS receiving vv-ECMO. The investigators have therefore designed this observational study to assess the modifications of mechanical properties of the respiratory system, ventilation and aeration distribution, and hemodynamics occurring during ECMO before and after prone position in patients with severe ARDS.

Conditions

• Acute Respiratory Distress Syndrome
• Acute Respiratory Failure

Interventions

Type	Name	Description
OTHER	Prone Position during Extra Corporeal Membrane Oxygenation (ECMO)	Pronation will be executed according to a predefined protocol: 4 caregivers will be required for the procedure, one of them being dedicated to the management of the head of the patient, the endotracheal tube and the ventilator lines. The others will stand at each side of the bed. In the first step, the direction of the rotation will be decided giving priority to the side of the central venous lines. The patient will be then moved along the horizontal plane to the opposite side of the bed selected for the direction of rotation. In the third step, the patient will be moved in the sagittal plane and maintained in that position for a short while to attach the cardiac electrodes to her/his back and to set a new bed sheet. In the last step, the patient will be turned to the complete prone position.

Timeline

• Start date: 2022-02-01
• Primary completion: 2023-02-28
• Completion: 2023-02-28
• First posted: 2022-01-20
• Last updated: 2022-01-20

Locations

1 site across 1 country: Italy