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NCT07858136
The Effect of Catheter Size on the Efficacy of Ultralow-flow Extracorporeal Carbon Dioxide Removal System in Acute Respiratory Distress Syndrome
Conditions: ARDS (Acute Respiratory Distress Syndrome)
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 30
Sponsor: Chulalongkorn University
Location: Chulalongkorn university Bangkok Bangkok
Summary
This pilot randomized controlled trial will evaluate whether catheter size affects the efficacy and performance of ultra-low-flow extracorporeal carbon dioxide removal (ECCO₂R) in mechanically ventilated adults with acute respiratory distress syndrome (ARDS) and hypercapnic respiratory acidosis. Participants will be randomly assigned to receive ECCO₂R using a 12F, 13F, or 15F catheter. The primary outcome is the percentage change in PaCO₂ from baseline during ECCO₂R. Secondary outcomes include achievement and time to correction of hypercapnic respiratory acidosis, changes in PaO₂, circuit lifespan, maximum blood flow, and device- and patient-related complications.
Eligibility Criteria
Inclusion Criteria:
Participants must meet all of the following criteria:
1. Age ≥18 years.
2. Acute respiratory distress syndrome (ARDS), mild to moderate severity, with a PaO₂/FiO₂ ratio of 100-300 while receiving PEEP ≥5 cmH₂O, after initiation of mechanical ventilation within the preceding 72 hours.
3. Hypercapnic respiratory acidosis, defined by PaCO₂ \>60 mmHg and/or arterial blood gas pH \15 cmH₂O;
* Plateau pressure \>27 cmH₂O;
* Tidal volume \>6 mL/kg predicted body weight; or
* Mechanical power \>17 J/min associated with respiratory rate \>25 breaths/min.
Exclusion Criteria:
* Severe shock that is preload non-responsive and requires norepinephrine \>1 µg/kg/min.
* Acute brain injury or cerebral edema, increased intracranial pressure, status epilepticus, intracerebral hemorrhage, or acute ischemic stroke.
* Pregnancy.
* Morbid obesity with BMI \>40 kg/m².
* Chronic respiratory acidosis.
* End-stage cancer patients.
* Coagulation disorders, defined as a platelet count of less than 10,000 cells/mm3 or an INR greater than 3.
* Patients undergoing targeted temperature management for 24 hours after return of spontaneous circulation.
* End-stage renal disease (ESRD) patients with a blood urea nitrogen (BUN) level greater than 60 mg/dL.
* Patients or legal representatives who do not consent to participation.
* Patients with an indication for ECMO according to the EOLIA trial criteria, specifically a PF ratio \< 50 mmHg more than 3 hours or a PF ratio \< 80 mmHg more than 6 hours.
Source: ClinicalTrials.gov (NCT07858136). StuddyBuddy aggregates publicly available trial information.