Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Niguarda Hospital | OTHER |
| San Gerardo Hospital | OTHER |
| Ospedale San Paolo | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HFNCOT+ECCO2R | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HFNCOT+ECCO2R | Procedure | NIV will be discontinued, the ECCO2R setting will be unchanged (both sweep gas flow and blood flow through the artificial lung) and HFNCOT will be started, titrating the fraction of inspired Oxygen (FiO2) to obtain an oxygen saturation at periphery (SpO2) 88-92%; HFNCOT start temperature will be 31°C, the initial flow rate will be 60 L/min. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of partecipants failing HFNCOT+ECCO2R treatment with need of restoring NIV or need of invasive mechanical ventilation | ECCO2R+HFNCOT failure criteria are defined by at least two of the following after at least 1 hour of treatment
| Through study completion, an average of 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of partecipants failing NIV+ECCO2R treatment with need of invasive mechanical ventilation | NIV+ECCO2R failure is defined by two of the following occurring for at least 2 hours:
| Through study completion, an average of 2 years |
Not provided
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:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Giacomo Grasselli, Professor | Contact | + 39 02 55036708 | giacomo.grasselli@unimi.it |
| Name | Affiliation | Role |
|---|---|---|
| Giacomo Grasselli, Professor | Policlinico Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale Maggiore Policlinico | Recruiting | Milan | 20122 | Italy |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Number of patients treated with ECCO2R reporting one or more side effects due to ECCO2R |
| Through study completion, an average of 2 years |
| Variation of pulmonary arterial pressure before and after ECCO2R treatment either in association with NIV or HNFCOT | Echocardiographic measurement | Through study completion, an average of 2 years |
| Variation of tricuspid annluar plane systolic excursion before and after ECCO2R treatment either in association with NIV or HNFCOT | Echocardiographic measurement | Through study completion, an average of 2 years |
| Variation of respiratory mechanic during ECCO2R+NIV | Measurement of Respiratory Rate (breaths per minute) | Through study completion, an average of 2 years |
| Variation of dyspnea during ECCO2R+NIV | 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) | Through study completion, an average of 2 years |
| Variation of comfort during ECCO2R+NIV | 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 | Through study completion, an average of 2 years |
| Variation of respiratory mechanic during ECCO2R+HFNCOT | Measurement of Respiratory Rate (breaths per minute) | Through study completion, an average of 2 years |
| Variation of dyspnea during ECCO2R+HFNCOT | 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 | Through study completion, an average of 2 years |
| Variation of comfort during ECCO2R+HFNCOT | 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 | Through study completion, an average of 2 years |
| Variation of breathing pattern during ECCO2R+NIV | Measurement of expiratory tidal volume, expressed in mL | Through study completion, an average of 2 years |
| Variation of breathing pattern during ECCO2R+NIV | Measurement of minute ventilation, expressed in liters/minute | Through study completion, an average of 2 years |
| Variation of acid-base balance during ECCO2R+NIV | emogasanalysis | Through study completion, an average of 2 years |
| Variation of acid-base balance during ECCO2R+HFNCOT | emogasanalysis | Through study completion, an average of 2 years |