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Clinical Trial Summary

Around 20% of the patients requiring hospitalization for Acute Exacerbation of Chronic Obstructive Pulmonary Disease (AECOPD) develop hypercapnia, which is associated with an increased risk of death. Once Non Invasive Ventilation (NIV) has been initiated, a reduction in Respiratory Rate (RR) and improvement in pH within 4 h predicts NIV success. If pH <7.25 and RR >35 breath per minutes persist, NIV failure is likely. Worsening acidosis, after initial improvement with NIV, is also associated with a worse prognosis. In addition, it has been shown that delaying intubation in patients at high risk for NIV failure has a negative impact on patient survival. Hence, assessing the risk of NIV failure is extremely important. NIV has some limitations: a) intolerance, discomfort and claustrophobia requiring frequent interruptions; b) poor patient-ventilator synchrony, especially in presence of air leaks or high ventilatory requirements. Since removing carbon dioxide by means of an artificial lung reduces the minute ventilation required to maintain an acceptable arterial partial pressure of carbon dioxide (PaCO2), the investigators hypothesize that applying Extra-Corporeal CO2 Removal (ECCO2R) in high-risk AECOPD patients may reduce the incidence of NIV failure and improve patient-ventilator interaction. After the beginning of ECCO2R, NIV could be gradually replaced by High Flow Nasal Cannula Oxygen Therapy (HFNCOT), potentially reducing the risk of ventilator induced lung injury, improving patient's comfort and probably allowing the adoption of a more physiologically "noisy" pattern of spontaneous breathing.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT03990155
Study type Interventional
Source Policlinico Hospital
Contact Giacomo Grasselli, Professor
Phone + 39 02 55036708
Email giacomo.grasselli@unimi.it
Status Recruiting
Phase N/A
Start date July 1, 2019
Completion date June 2022

See also
  Status Clinical Trial Phase
Not yet recruiting NCT06114667 - Nasal High Flow Versus Non-invasive Ventilation for Early Treatment of Acute Exacerbation of Chronic Obstructive Pulmonary Disease With Hypercapnic Acidosis N/A
Recruiting NCT04962568 - Ultrasonographic Evaluation of the Diaphragm During NHF Versus NIV Use in Respiratory Failure N/A
Recruiting NCT05989971 - The Effect of Continuous Renal Replacement Therapy on the Efficiency of Extracorporeal CO2 Removal