NCT02107222

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

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Maquet Cardiopulmonary GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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).

Conditions

• COPD
• Chronic Obstructive Pulmonary Disease

Interventions

Type	Name	Description
DEVICE	CO2-Removal (PALP-Device/MaquetCP)	extracorporeal circuit to remove CO2 out of the blood

Timeline

• Primary completion: 2016-12-01
• First posted: 2014-04-08
• Last updated: 2016-04-01

Locations

1 site across 1 country: Germany