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NCT Number: NCT07785375

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

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.

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Key information

Conditions

Acute Exacerbation of Chronic Obstructive Pulmonary Disease Acid-Base Imbalance Acidosis Acidosis, Respiratory Metabolic Diseases Nutritional and Metabolic Diseases Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital del Mar

Barcelona, 08023, Spain

Location contact

Andrea Castellví-Font, MD, PhD

SUB_INVESTIGATOR

Clara Vilà Vilardell, MD

SUB_INVESTIGATOR

Francisco José Parrilla Gómez, MD, PhD

CONTACT

[email protected]

+34 93 248 30 14

Francisco José Parrilla Gómez, MD, PhD

PRINCIPAL_INVESTIGATOR

Joan Ramon Masclans Enviz, MD, PhD

CONTACT

[email protected]

+34 93 248 30 14

Joan Ramon Masclans Enviz, MD, PhD

SUB_INVESTIGATOR

Laia Ribó, MD

SUB_INVESTIGATOR

Maria Acer Puig, MD

SUB_INVESTIGATOR

Purificación Pérez Terán, MD, PhD

SUB_INVESTIGATOR

Rosana Muñoz Bermúdez, MD

SUB_INVESTIGATOR

About this study

Acute exacerbations of chronic obstructive pulmonary disease (COPD) may cause severe hypercapnic respiratory failure. Noninvasive ventilation (NIV) is the standard initial respiratory support, but some patients have persistent respiratory acidosis despite NIV. Treatment options are particularly limited when invasive mechanical ventilation is not considered appropriate or is declined by the patient.

Extracorporeal carbon dioxide removal (ECCO2R) uses a low-flow extracorporeal circuit to remove carbon dioxide directly from the blood. When used together with NIV, ECCO2R may reduce the ventilatory demand and work of breathing, improve respiratory acidosis, and facilitate earlier withdrawal of NIV.

This single-center, open-label, randomized proof-of-concept trial will compare NIV plus ECCO2R with NIV alone in patients with an acute exacerbation of COPD and persistent hypercapnic respiratory acidosis after 4 hours of NIV. The study is intended to provide preliminary evidence regarding the physiological effects, clinical feasibility, and safety of adding ECCO2R to standard NIV in this highly selected population. The findings may inform the design of larger clinical trials.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: 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.

Other names: NIV

Primary outcomes

  1. Change in Respiratory Rate From Baseline to 4 Hours

    Time frame: 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.

Secondary outcomes

  1. Change in Arterial Carbon Dioxide Pressure

    Time frame: Baseline and 4 hours after initiation of the assigned treatment

    Change in arterial partial pressure of carbon dioxide (PaCO2), measured in mmHg, from baseline to 4 hours after initiation of the assigned treatment.

  2. Change in Arterial pH

    Time frame: Baseline and 4 hours after initiation of the assigned treatment

    Change in arterial blood pH from baseline to 4 hours after initiation of the assigned treatment.

  3. Duration of Noninvasive Ventilation

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

    Total duration of noninvasive ventilation, measured in hours, from initiation until permanent discontinuation during the index hospitalization.

  4. Hospital Length of Stay

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

    Number of days from hospital admission to hospital discharge or in-hospital death.

  5. In-Hospital Mortality

    Time frame: From randomization through hospital discharge, anticipated up to 90 days

    All-cause mortality occurring during the index hospitalization.

  6. Incidence of ECCO2R-Related Adverse Events

    Time frame: From initiation of ECCO2R through hospital discharge or death, anticipated up to 90 days

    Number and proportion of participants experiencing one or more adverse events considered related to ECCO2R, including bleeding, thrombocytopenia, vascular catheter complications, hemolysis, circuit clotting, air entry, reduced blood flow, or other mechanical system failures.

Other outcomes

  1. Intensive Care Unit Length of Stay

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

    Number of days from intensive care unit admission to intensive care unit discharge or death in the intensive care unit.

Study contacts

Contact information is provided by the study sponsor or research team.

Andrea Castellvi-Font, MD, PhD

CONTACT

[email protected]

+34 636568294

Francisco José Parrilla Gómez, MD, PhD

CONTACT

[email protected]

+34 93 248 30 14

Sponsors and collaborators

Lead sponsor

Hospital del Mar Research Institute (IMIM)

Other

Registry information

Official study title

Randomized Clinical Trial of the Efficacy of Extracorporeal Carbon Dioxide Removal and Noninvasive Ventilation in Patients With COPD Not Eligible for Endotracheal Intubation

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Aug 25, 2026
Registry last updated
Aug 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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