The PALP™-COPD Trial (Low-Flow CO2-Removal (ECCO2-R) in Exacerbated COPD)

Study Overview
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Brief Summary
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A Multicenter, Randomized, Controlled Trial to Determine Safety and Efficacy of Pump Assisted Lung Protection (PALP™) for Low Flow Carbon Dioxide (CO2) Removal in Conjunction with Liberation from Mechanical Ventilation Compared to Mechanical Ventilation Alone in Patients with COPD Exacerbation and Respiratory Failure

Detailed Description
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Primary Study Objectives • To evaluate the clinical effect of PALP™ in reducing the time on invasive ventilation in patients with an exacerbation of COPD requiring invasive mechanical ventilation. Secondary Study Objectives To evaluate the safety and tolerability of PALP™ in patients with an exacerbation of COPD requiring invasive mechanical ventilation. To determine if rates of adverse events (AEs) are reduced in patients who receive PALP™ and invasive mechanical ventilation vs invasive mechanical ventilation alone. To determine mortality rates in patients who receive PALP™ and invasive mechanical ventilation vs invasive mechanical ventilation alone. To determine if PALP™ will effectively reduce the number of subsequent acute decompensations requiring hospital admission for ventilatory support (invasive or noninvasive).

Official Title
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A Multicenter Randomized Control Trial (RCT) to Determine Safety and Efficacy of PALP™ for ECCO2-R in Conjunction With Liberation From Mechanical Ventilation (MV) Compared to MV Alone in COPD Exacerbation and Respiratory Failure

Conditions
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COPD, Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Device: CO2-Removal (PALP-Device/MaquetCP)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female, and ≥40 years of age Known history of COPD Currently experiencing an exacerbation of COPD P/F ratio >150 mmHg Currently endotracheally intubated and requiring invasive mechanical ventilation (must have been on invasive mechanical ventilation for 24-48 hours) Able to tolerate large bore intravenous (IV) cannulation required for proper operation of study device For female patients of child-bearing potential, a negative urine or serum pregnancy test at screening; all female patients will be considered of child-bearing potential unless they are post menopausal for at least 1 year or have been surgically sterilized (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy) Written informed consent obtained according to local regulations; or, if unable to provide written informed consent due to incapacitation, a legally authorized representative is able to provide written informed consent on behalf of the patient Exclusion Criteria: Any end-stage medical conditions with expected survival <6 months Tracheostomy Unable to provide central venous access Acute brain injury Any legally authorized document(s) that may restrict aggressive medical management such as Do Not Resuscitate, Do Not Intubate, etc. Risk of bleeding or clotting such as: Known bleeding diathesis or abnormal clotting Recent or current use of medications known to increase risk of bleeding Screening platelet count of <75,000/mm3 or international normalized ratio (INR) >1.5 or activated partial thromboplastin time (aPTT) >1.5 times the upper limit of normal (ULN) range for their respective laboratory values Any recognized contra indications to systemic anticoagulation therapy or use of heparin Body mass index (BMI) >35 Any form of chronic hyperventilation not related to COPD Hemodynamic instability or requiring significant vasopressor support Cardiogenic or noncardiogenic pulmonary edema as the primary reason for respiratory failure High risk cardiac conditions Oxygen tension in arterial blood (PaO2) <50 mmHg via arterial blood gas (ABG) or any condition in which hypoxemia is a significant component of the respiratory failure Any other medical cause for acute respiratory failure not directly related to a COPD exacerbation Use of or treatment with an investigational drug, therapy, or device within 1 month (30 days) of baseline Female patients who are pregnant or breastfeeding Patients who are immuno-compromised Current active malignancy or history of malignancy within the past 5 years Patients in chronic dialysis Patients requiring extra-corporeal life support (ECLS) as a bridge to transplant Patients who, in the opinion of the investigator, would not be able to comply with the requirements of the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: mechanical ventilation (MV)<br>mechanical ventilation according to guidelines | |
| Experimental: MV + ECCO2-R(PALP-Device/MaquetCP)<br>MV according to the guidelines plus CO2-Removal with PALP | Device: CO2-Removal (PALP-Device/MaquetCP)<br>* extracorporeal circuit to remove CO2 out of the blood<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in time of mechanical ventilation | • To evaluate the clinical effect of PALP™ in reducing the time on invasive ventilation in patients with an exacerbation of COPD requiring invasive mechanical ventilation. | 720 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD, Exacerbation, invasive ventilation, CO2-Removal