Extracorporeal Carbon Dioxide Removal Plus Noninvasive Ventilation in Patients With COPD Not Eligible for Intubation

NCT07785375 · tracked via the Priya Life Science Spain tracker

Sponsor

Hospital del Mar Research Institute (IMIM)

Phase

Not applicable

Started

2026-09

Last updated

2026-08-25

Condition(s) studied

Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Investigational drug(s) / intervention(s)

Extracorporeal Carbon Dioxide RemovalNoninvasive Ventilation

Extracorporeal Carbon Dioxide Removal: Low-flow extracorporeal carbon dioxide removal will be provided using the Prismalung+ membrane connected to the PrisMax 2 system. Treatment will be initiated within 12 hours after randomization through a 13- to 14-Fr double-lumen venous catheter. The initial sweep gas flow will be 10 L/min, and blood flow will be set as high as tolerated by the system, with a target of approximately 450 mL/min. Treatment settings will be adjusted according to carbon dioxide removal and arterial pH.

Noninvasive Ventilation: Noninvasive ventilation will be delivered according to current clinical guidelines and usual clinical practice. Ventilator settings and duration of treatment will be adjusted by the treating clinical team according to the participant's respiratory status and clinical response.

Study summary

This study will evaluate whether adding extracorporeal carbon dioxide removal (ECCO2R) to noninvasive ventilation can improve breathing in adults hospitalized with a severe worsening of chronic obstructive pulmonary disease (COPD). Participants will have high carbon dioxide levels and increased acidity in their blood despite treatment with noninvasive ventilation and will not be eligible for invasive mechanical ventilation through a breathing tube.

A total of 14 participants will be assigned by chance to receive either noninvasive ventilation alone or noninvasive ventilation together with ECCO2R. ECCO2R removes carbon dioxide directly from the blood through a catheter placed in a large vein. The main aim is to determine whether adding ECCO2R reduces the breathing rate within 4 hours. The study will also assess blood carbon dioxide and acidity, duration of noninvasive ventilation, length of hospital stay, survival, and complications related to ECCO2R.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Age 18 years or older. * Confirmed diagnosis of chronic obstructive pulmonary disease (COPD). * Acute exacerbation of COPD, defined as increased dyspnea, cough, and/or sputum production. * Acute hypercapnic respiratory failure requiring noninvasive ventilation, with arterial pH \<7.30 and PaCO2 \>50 mmHg. * Not eligible for endotracheal intubation because of a medical decision or the participant's prior decision. * Persistent respiratory acidosis, defined as arterial pH \<7.30 with PaCO2 \>45 mmHg, after 4 hours of noninvasive ventilation. Exclusion Criteria: * Contraindication to extracorporeal carbon dioxide removal due to a coagulation disorder. * Inability to establish adequate vascular access.

Primary outcome measure(s)

Change in Respiratory Rate From Baseline to 4 Hours — Baseline and 4 hours after initiation of the assigned treatment
Change in respiratory rate, measured in breaths per minute, from the study baseline to 4 hours after initiation of ECCO2R in the experimental arm or the corresponding study time point in the control arm. A negative value indicates a reduction in respiratory rate.

Trial sites (1)

Facility	City	Region	Status
Hospital del Mar	Barcelona	Spain

More Hospital del Mar Research Institute (IMIM) trials in Spain

Predicting High-Flow Nasal Cannula Failure in Acute Hypoxemic Respiratory Failure Using Metabolomics and Clinical Data Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07785375 on ClinicalTrials.gov ↗ ← All trials in Spain