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A pragmatic randomised controlled trial to determine whether early Veno-Venous Extracorporeal Carbon Dioxide Removal (VV-ECCO2R) in mechanically ventilated patients with acute exacerbated Chronic Obstructive Pulmonary Disease decreases the days of invasive mechanical ventilation.
Chronic obstructive pulmonary disease (COPD) is a major worldwide health burden. Currently, it is the fourth leading cause of death worldwide, and is the only leading cause of death that is rising, and will likely become the third cause of death by 2020. COPD is characterized by progressive destruction in the elastic tissue within the lung, causing respiratory failure. Patients with COPD may experience acute exacerbations with severe hypercapnic respiratory failure. Hypercapnia results from acute worsening of expiratory flow limitation caused by the increased small airway resistance with consequent development of dynamic alveolar hyperinflation and intrinsic positive end-expiratory pressure (PEEP). In the most severe cases, these may be refractory to conventional therapies and mechanical ventilation, becoming life-threatening. Extracorporeal carbon dioxide removal (ECCO2R) represents an attractive approach in this setting. The last decade has seen an increasing interest in the provision of extracorporeal support for respiratory failure, as demonstrated by the progressively increasing number of scientific publications on this topic. In particular, remarkable interest has been focused on extracorporeal carbon dioxide removal (ECCO2R), due to the relative ease and efficiency in blood CO2 clearance granted by extracorporeal gas exchangers as compared to oxygen delivery. In recent years, a new generation of ECCO2R devices has been developed. More efficient veno-venous (VV)-ECCO2R devices have become available and have replaced the arterio-venous approach, having the advantage of not requiring arterial puncture. The new VV-ECCO2R devices offer lower resistance to blood flow, have smaller priming volumes, and provide a much more efficient gas exchange with relatively low extracorporeal blood flows (0.4-1 L/min). The technology of these devices is now comparable to that of renal dialysis and has been experimented in several animal and human studies, demonstrating a significant reduction in arterial CO2 and improvement in the work of breathing. In summary, minimally invasive ECCO2R appears very promising for patients with acute exacerbation of obstructive diseases refractory to conventional treatment, but systematic evaluation is needed to prove its clinical efficacy.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Start Date
February 1, 2021
Primary Completion Date
June 1, 2023
Completion Date
June 1, 2023
Last Updated
August 20, 2020
90
ESTIMATED participants
Low flow ECCO2R
DEVICE
Invasive mechanical ventilation
DEVICE
Lead Sponsor
Hospital Quiron Sagrado Corazon
NCT06084117
NCT05563493
NCT03255057
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