Clinical trial NCT03990155: Extra-Corporeal Carbon Dioxide Removal in Exacerbations of Chronic Obstructive Pulmonary Disease
Official title: Treatment of Acute Exacerbation of Chronic Obstructive Pulmonary Disease With Extracorporeal Carbon Dioxide Removal Associated With High Flow Nasal Cannula Oxygen Therapy. Pilot Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Respiratory Failure With Hypercapnia
Lead sponsor: Policlinico Hospital
Sponsor class: OTHER
Collaborators: name: Niguarda Hospital
name: San Gerardo Hospital
name: Ospedale San Paolo
First posted: 2019-06-18
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of partecipants failing HFNCOT+ECCO2R treatment with need of restoring NIV or need of invasive mechanical ventilation
timeFrame: Through study completion, an average of 2 years
Secondary outcomes:
measure: Number of partecipants failing NIV+ECCO2R treatment with need of invasive mechanical ventilation
timeFrame: Through study completion, an average of 2 years
measure: Number of patients treated with ECCO2R reporting one or more side effects due to ECCO2R
timeFrame: Through study completion, an average of 2 years
measure: Variation of pulmonary arterial pressure before and after ECCO2R treatment either in association with NIV or HNFCOT
timeFrame: Through study completion, an average of 2 years
measure: Variation of tricuspid annluar plane systolic excursion before and after ECCO2R treatment either in association with NIV or HNFCOT
timeFrame: Through study completion, an average of 2 years
measure: Variation of respiratory mechanic during ECCO2R+NIV
timeFrame: Through study completion, an average of 2 years
measure: Variation of dyspnea during ECCO2R+NIV
timeFrame: Through study completion, an average of 2 years
measure: Variation of comfort during ECCO2R+NIV
timeFrame: Through study completion, an average of 2 years
measure: Variation of respiratory mechanic during ECCO2R+HFNCOT
timeFrame: Through study completion, an average of 2 years
measure: Variation of dyspnea during ECCO2R+HFNCOT
timeFrame: Through study completion, an average of 2 years
measure: Variation of comfort during ECCO2R+HFNCOT
timeFrame: Through study completion, an average of 2 years
measure: Variation of breathing pattern during ECCO2R+NIV
timeFrame: Through study completion, an average of 2 years
measure: Variation of breathing pattern during ECCO2R+NIV
timeFrame: Through study completion, an average of 2 years
measure: Variation of acid-base balance during ECCO2R+NIV
timeFrame: Through study completion, an average of 2 years
measure: Variation of acid-base balance during ECCO2R+HFNCOT
timeFrame: Through study completion, an average of 2 years
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Ospedale Maggiore Policlinico
Study officials:
affiliation: Policlinico Hospital
name: Giacomo Grasselli, Professor
role: PRINCIPAL_INVESTIGATOR
References: