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

NCT07785375 | Not Yet Recruiting

• 1 other identifier: ECCO2R NIT2B
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Keywords

Extracorporeal Carbon Dioxide Removal; ECCO2R; Noninvasive Ventilation; NIV; Acute Hypercapnic Respiratory Failure; Respiratory Acidosis; COPD Exacerbation; Do-Not-Intubate Order

Outcome Measures

Primary Outcomes (1)

• Change in Respiratory Rate From Baseline to 4 Hours

  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.

  Baseline and 4 hours after initiation of the assigned treatment

Secondary Outcomes (6)

• Change in Arterial Carbon Dioxide Pressure

  Baseline and 4 hours after initiation of the assigned treatment

• Change in Arterial pH

  Baseline and 4 hours after initiation of the assigned treatment

• Duration of Noninvasive Ventilation

  From initiation of noninvasive ventilation until its permanent discontinuation, assessed through hospital discharge or death

• Hospital Length of Stay

  From hospital admission through hospital discharge or death, anticipated up to 90 days

• In-Hospital Mortality

  From randomization through hospital discharge, anticipated up to 90 days

Other Outcomes (1)

• Intensive Care Unit Length of Stay

  From intensive care unit admission through intensive care unit discharge or death, anticipated up to 90 days

Study Arms (2)

NIV Plus ECCO2R

EXPERIMENTAL

Participants receive standard noninvasive ventilation together with extracorporeal carbon dioxide removal.

Device: Extracorporeal Carbon Dioxide Removal; Device: Noninvasive Ventilation

NIV Alone

ACTIVE COMPARATOR

Participants continue to receive standard noninvasive ventilation alone according to current clinical guidelines and usual clinical practice.

Device: Noninvasive Ventilation

Interventions

Extracorporeal Carbon Dioxide Removal DEVICE

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.

Also known as: ECCO2R

NIV Plus ECCO2R

Noninvasive Ventilation DEVICE

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.

Also known as: NIV

NIV Alone; NIV Plus ECCO2R

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Contraindication to extracorporeal carbon dioxide removal due to a coagulation disorder.
• Inability to establish adequate vascular access.

Sponsors & Collaborators

• Hospital del Mar Research Institute (IMIM): lead

Study Sites (1)

Hospital del Mar

Barcelona, 08023, Spain

Location

MeSH Terms

Conditions

Respiratory Insufficiency; Acidosis, Respiratory

Interventions

Noninvasive Ventilation

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Acidosis; Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Francisco José Parrilla Gómez, MD, PhD

  Hospital del Mar

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francisco José Parrilla Gómez, MD, PhD

CONTACT

+34 93 248 30 14; fparrilla@hmar.cat

Andrea Castellvi-Font, MD, PhD

CONTACT

+34 636568294; acastellvifont@hmar.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Intensivist and Clinical Researcher, Department of Intensive Care Medicine

Model Details: Participants are randomly assigned in a 1:1 ratio to receive either noninvasive ventilation plus extracorporeal carbon dioxide removal or noninvasive ventilation alone.

Study Record Dates

• First Submitted: August 21, 2026
• First Posted: August 25, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: August 25, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)