Extra-Corporeal Carbon Dioxide Removal in Exacerbations of Chronic Obstructive Pulmonary Disease

  • STATUS
    Recruiting
  • days left to enroll
    37
  • participants needed
    40
  • sponsor
    Policlinico Hospital
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Updated on 10 February 2022
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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.

Details
Condition Respiratory Failure With Hypercapnia
Treatment HFNCOT+ECCO2R
Clinical Study IdentifierNCT03990155
SponsorPoliclinico Hospital
Last Modified on10 February 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

Patients admitted to Emergency or Pulmonology Department, with history of COPD
(pulmonary function test available, any Global Obstructive Lung Disease -GOLD-
stage), treated with NIV for acute hypercapnic respiratory failure due to
AECOPD defined by
pH <7.35 + PaCO2 >45 mmHg (acute hypercapnic respiratory failure) or pH <7.35 + PaCO2 > 20% of baseline value (acute on chronic hypercapnic respiratory failure)
Acute worsening of respiratory symptoms that results in additional therapy
Respiratory failure not fully explainable with cardiac failure and at high risk for NIV failure, defined by
No improvement or worsening of respiratory acidosis (pH <7.35 and PaCO2 >45 mmHg) after 2 hours of NIV + one of the following: RR 30 bpm; use of accessory respiratory muscle or paradoxical breathing (Combination criteria for NIV failure) or
Glasgow Coma Scale 11 after 2 hours of NIV (Single criteria for NIV failure) or
Inability to fit mask (facial deformity/intervention/burns) or marked intolerance to interface because of patient's agitation (Single Criteria for NIV failure)

Exclusion Criteria

Age >80 years old
Contraindications to anticoagulation (any of the following: platelet count <30.000/mm3; activated partial thromboplastin time (aPTT) >1,5; stroke or severe head trauma or intracranial arteriovenous malformation or cerebral aneurysm in the previous 3 months; central nervous system mass lesion; history of congenital bleeding diatheses; gastro-intestinal bleeding in the previous 6 weeks; gastro-esophageal varices)
Cirrhosis
PaO2/FiO2 150 mmHg
Hemodynamic instability (80-90 mmHg increase or 30-40 mmHg decrease systolic arterial pressure compared to baseline value or need of vasopressors to maintain systolic blood pressure higher than 85 mmHg or electrocardiogram evidence of ischemia/arrhythmias)
Body Mass Index 37
Impending respiratory arrest
Catheter access to femoral vein or jugular vein impossible
Patient moribund, decision to limit therapeutic interventions
Opposition to participate obtained from the patient or their legally acceptable representative
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