Acute Exacerbation of Chronic Obstructive Pulmonary DiseaseNCT07785375
Extracorporeal Carbon Dioxide Removal Plus Noninvasive Ventilation in Patients With COPD Not Eligible for Intubation
A study testing Extracorporeal Carbon Dioxide Removal and Noninvasive Ventilation in people with Acute Exacerbation of Chronic Obstructive Pulmonary Disease, run by Hospital del Mar Research Institute (IMIM) at 1 site in Spain.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Exacerbation of Chronic Obstructive Pulmonary Disease
- What is being tested?
- Extracorporeal Carbon Dioxide Removal and Noninvasive Ventilation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2026to Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Contraindication to extracorporeal carbon dioxide removal due to a coagulation disorder.
- Inability to establish adequate vascular access.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Hospital del Mar
Barcelona, 08023
Francisco José Parrilla Gómez, MD, PhD, +34 93 248 30 14, fparrilla@hmar.cat
Joan Ramon Masclans Enviz, MD, PhD, +34 93 248 30 14, jmasclans@hmar.cat
About this study
Official title: Randomized Clinical Trial of the Efficacy of Extracorporeal Carbon Dioxide Removal and Noninvasive Ventilation in Patients With COPD Not Eligible for Endotracheal 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.
Read the detailed description
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.
- Being tested
- Extracorporeal Carbon Dioxide Removal, Noninvasive Ventilation
- Keywords
- Extracorporeal Carbon Dioxide Removal, ECCO2R, Noninvasive Ventilation, NIV, Acute Hypercapnic Respiratory Failure, Respiratory Acidosis, COPD Exacerbation, Do-Not-Intubate Order
- Medical subject headings
- Respiratory Insufficiency, Acidosis, Respiratory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracorporeal Carbon Dioxide RemovalDevice
Also called ECCO2R
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 VentilationDevice
Also called NIV
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 group | Role | What they receive |
|---|---|---|
| NIV Plus ECCO2R | Experimental | Participants receive standard noninvasive ventilation together with extracorporeal carbon dioxide removal. Receives: 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. Receives: Device: Noninvasive Ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 4 hours after initiation of the assigned treatment
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From hospital admission through hospital discharge or death, anticipated up to 90 days
In-Hospital Mortality
All-cause mortality occurring during the index hospitalization.
Measured: 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.
Measured: From initiation of ECCO2R through hospital discharge or death, anticipated up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Exacerbation of Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned in a 1:1 ratio to receive either noninvasive ventilation plus extracorporeal carbon dioxide removal or noninvasive ventilation alone.
- Masking
- None (open label)
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital del Mar Research Institute (IMIM)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Castellvi, Hospital del Mar Research Institute (IMIM)
- Investigators
- Francisco José Parrilla Gómez, MD, PhD, Principal investigator, Hospital del Mar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07785375
- Sponsor's protocol ID
- ECCO2R NIT2B
- Status last verified
- Aug 2026
- First submitted
- 21 Aug 2026
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial of the Efficacy of Extracorporeal Carbon Dioxide Removal and Noninvasive Ventilation in Patients With COPD Not Eligible for Endotracheal Intubation
- ClinicalTrials.gov ID
- NCT07785375
- Acronym / sponsor ID
- ECCO2R NIT2B
- Keywords
- Extracorporeal Carbon Dioxide Removal, ECCO2R, Noninvasive Ventilation, NIV, Acute Hypercapnic Respiratory Failure, Respiratory Acidosis, COPD Exacerbation, Do-Not-Intubate Order
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Hospital del Mar Research Institute (IMIM)University, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 25 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are randomly assigned in a 1:1 ratio to receive either noninvasive ventilation plus extracorporeal carbon dioxide removal or noninvasive ventilation alone.
| Arm | Type | Receives |
|---|---|---|
| NIV Plus ECCO2R | Experimental | Device: Extracorporeal Carbon Dioxide Removal, Device: Noninvasive VentilationParticipants receive standard noninvasive ventilation together with extracorporeal carbon dioxide removal. |
| NIV Alone | Active comparator | Device: Noninvasive VentilationParticipants continue to receive standard noninvasive ventilation alone according to current clinical guidelines and usual clinical practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (2 listed)
- Contraindication to extracorporeal carbon dioxide removal due to a coagulation disorder.
- Inability to establish adequate vascular access.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extracorporeal Carbon Dioxide RemovalAlso: ECCO2RLow-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. | Device | NIV Plus ECCO2R |
| Noninvasive VentilationAlso: NIVNoninvasive 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. | Device | NIV Alone, NIV Plus ECCO2R |
Primary outcome
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.
6 secondary outcomes
Change in Arterial Carbon Dioxide Pressure
Time frame: Baseline and 4 hours after initiation of the assigned treatment
Change in Arterial pH
Time frame: Baseline and 4 hours after initiation of the assigned treatment
Duration of Noninvasive Ventilation
Time frame: From initiation of noninvasive ventilation until its permanent discontinuation, assessed through hospital discharge or death
Hospital Length of Stay
Time frame: From hospital admission through hospital discharge or death, anticipated up to 90 days
In-Hospital Mortality
Time frame: From randomization through hospital discharge, anticipated up to 90 days
Incidence of ECCO2R-Related Adverse Events
Time frame: From initiation of ECCO2R through hospital discharge or death, anticipated up to 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Francisco José Parrilla Gómez, MD, PhD principal investigator
Hospital del Mar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extracorporeal Carbon Dioxide Removal and Noninvasive Ventilation in people with Acute Exacerbation of Chronic Obstructive Pulmonary Disease, run by Hospital del Mar Research Institute (IMIM) at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Francisco José Parrilla Gómez, MD, PhD (+34 93 248 30 14, fparrilla@hmar.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Respiratory Rate From Baseline to 4 Hours (time frame: Baseline and 4 hours after initiation of the assigned treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.