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NCT07785375
Extracorporeal Carbon Dioxide Removal Plus Noninvasive Ventilation in Patients With COPD Not Eligible for Intubation
Conditions: Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 14
Sponsor: Hospital del Mar Research Institute (IMIM)
Location: Hospital del Mar Barcelona
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 Criteria
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 \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 \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.
Source: ClinicalTrials.gov (NCT07785375). StuddyBuddy aggregates publicly available trial information.