Extra-Corporeal Carbon Dioxide Removal in Exacerbations of Chronic Obstructive Pulmonary Disease
- Conditions
- Respiratory Failure With Hypercapnia
- Interventions
- Procedure: HFNCOT+ECCO2R
- Registration Number
- NCT03990155
- Lead Sponsor
- Policlinico Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 40
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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description HFNCOT+ECCO2R HFNCOT+ECCO2R Patients on NIV+ECCO2R who have reached at least for 4 consecutive hours, a RR \<25 bpm + pH \>7.35 + absence of clinical signs of respiratory distress after treatment with NIV+ECCO2R
- Primary Outcome Measures
Name Time Method Number of partecipants failing HFNCOT+ECCO2R treatment with need of restoring NIV or need of invasive mechanical ventilation Through study completion, an average of 2 years ECCO2R+HFNCOT failure criteria are defined by at least two of the following after at least 1 hour of treatment
1. Respiratory acidosis (pH \<7.35)
2. RR ≥ 30 bpm
3. Development of progressive hypoxemia (PaO2/FiO2 \< 150)
4. Paradoxical breathing
- Secondary Outcome Measures
Name Time Method Variation of dyspnea during ECCO2R+NIV Through study completion, an average of 2 years Measurement of dyspnea through Borg dyspnea scale. (ranging from a minimum of 0 point, indicating no shortness of breath, to a maximum of 10 points, indicating maximum shortness of breath)
Variation of respiratory mechanic during ECCO2R+NIV Through study completion, an average of 2 years Measurement of Respiratory Rate (breaths per minute)
Variation of respiratory mechanic during ECCO2R+HFNCOT Through study completion, an average of 2 years Measurement of Respiratory Rate (breaths per minute)
Variation of acid-base balance during ECCO2R+NIV Through study completion, an average of 2 years emogasanalysis
Number of patients treated with ECCO2R reporting one or more side effects due to ECCO2R Through study completion, an average of 2 years 1. Bleeding (any bleeding event requiring the administration of 1 U of packed red cells)
2. Vein perforation at cannula insertion
3. 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)
4. Pneumothorax
5. Ischemic bowel
6. Acute kidney failure
7. Neurological complications (occurrence, after initiation of ECCO2R, of ischemic/hemorrhagic ictus or clinical seizure or cerebral oedema)
8. Metabolic complications (occurrence, after initiation of ECCO2R of hyperbilirubinemia or glucose≥240 mg/dL)
9. Thromboembolic complications (occurrence, after initiation of ECCO2R, of deep venous thrombosis, pulmonary embolism)Variation of comfort during ECCO2R+HFNCOT Through study completion, an average of 2 years Measurement of comfort through Visual Analogic Scale for comfort, ranging from a minimum of 0 point, indicating no comfort, to a maximun of 10 point, indicating maximum comfort
Variation of acid-base balance during ECCO2R+HFNCOT Through study completion, an average of 2 years emogasanalysis
Variation of tricuspid annluar plane systolic excursion before and after ECCO2R treatment either in association with NIV or HNFCOT Through study completion, an average of 2 years Echocardiographic measurement
Variation of breathing pattern during ECCO2R+NIV Through study completion, an average of 2 years Measurement of minute ventilation, expressed in liters/minute
Number of partecipants failing NIV+ECCO2R treatment with need of invasive mechanical ventilation Through study completion, an average of 2 years NIV+ECCO2R failure is defined by two of the following occurring for at least 2 hours:
1. No improvement or worsening of respiratory acidosis (pH \<7.35)
2. RR ≥30 bpm
3. Development of progressive hypoxemia (PaO2/FiO2 ≤150)Variation of pulmonary arterial pressure before and after ECCO2R treatment either in association with NIV or HNFCOT Through study completion, an average of 2 years Echocardiographic measurement
Variation of comfort during ECCO2R+NIV Through study completion, an average of 2 years Measurement of comfort through Visual Analogic Scale for comfort, ranging from a minimum of 0 point, indicating no comfort, to a maximun of 10 point, indicating maximum comfort
Variation of dyspnea during ECCO2R+HFNCOT Through study completion, an average of 2 years Measurement of dyspnea through Borg dyspnea scale, ranging from a minimum of 0 point, indicating no shortness of breath, to a maximum of 10 points, indicating maximum shortness of breath
Trial Locations
- Locations (1)
Ospedale Maggiore Policlinico
🇮🇹Milan, Italy