An interventional study of Extracorporeal Carbon Dioxide Removal and Noninvasive Ventilation in Acute Exacerbation of Chronic Obstructive Pulmonary Disease, sponsored by Hospital del Mar Research Institute (IMIM). Not yet recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-25.
Sponsored by Hospital del Mar Research Institute (IMIM) · Not applicable, Interventional, and Treatment
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.
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.
1,369 studies on the registry are indexed under Respiratory Insufficiency; 264 are open to participants now.
This study's planned enrollment of 14 is below the median of 60 across 860 interventional studies indexed under Respiratory Insufficiency.
Browse Respiratory Insufficiency studies →Hospital del Mar Research Institute (IMIM) is the lead sponsor of 7 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive standard noninvasive ventilation together with extracorporeal carbon dioxide removal.
Device: Extracorporeal Carbon Dioxide Removal · Device: Noninvasive Ventilation
Participants continue to receive standard noninvasive ventilation alone according to current clinical guidelines and usual clinical practice.
Device: Noninvasive Ventilation
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
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
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.
Time frame: Baseline and 4 hours after initiation of the assigned treatment
Change in Arterial Carbon Dioxide Pressure
Change in arterial partial pressure of carbon dioxide (PaCO2), measured in mmHg, from baseline to 4 hours after initiation of the assigned treatment.
Time frame: Baseline and 4 hours after initiation of the assigned treatment
Change in Arterial pH
Change in arterial blood pH from baseline to 4 hours after initiation of the assigned treatment.
Time frame: Baseline and 4 hours after initiation of the assigned treatment
Duration of Noninvasive Ventilation
Total duration of noninvasive ventilation, measured in hours, from initiation until permanent discontinuation during the index hospitalization.
Time frame: From initiation of noninvasive ventilation until its permanent discontinuation, assessed through hospital discharge or death
Hospital Length of Stay
Number of days from hospital admission to hospital discharge or in-hospital death.
Time frame: From hospital admission through hospital discharge or death, anticipated up to 90 days
In-Hospital Mortality
All-cause mortality occurring during the index hospitalization.
Time frame: From randomization through hospital discharge, anticipated up to 90 days
Incidence of ECCO2R-Related Adverse Events
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.
Time frame: From initiation of ECCO2R through hospital discharge or death, anticipated up to 90 days
Intensive Care Unit Length of Stay
Number of days from intensive care unit admission to intensive care unit discharge or death in the intensive care unit.
Time frame: From intensive care unit admission through intensive care unit discharge or death, anticipated up to 90 days
Plan to share: No — Individual participant data will not be shared because the study protocol and informed consent documents do not authorize the transfer of participant-level data to researchers outside the study team. Aggregate study results may be reported in scientific publications and presentations.
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Sep 2027, 12 months later.
Of 359 non-industry interventional studies with no phase under Respiratory Insufficiency, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 47. This study's planned 12 months is below that.
Counting every sponsor, half of 375 studies reached it within 24 months; a quarter within 10 and three quarters within 46.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Hospital del Mar Research Institute (IMIM)