Post-Market Study of Low-flow ECCO2R Using PrismaLung+ (NCT04617093) | Clinical Trial Compass
CompletedNot Applicable
Post-Market Study of Low-flow ECCO2R Using PrismaLung+
France63 participantsStarted 2021-04-30
Plain-language summary
PrismaLung+ is intended to provide extracorporeal carbon dioxide removal (ECCO2R) as a standalone therapy or in combination with continuous renal replacement therapy (CRRT). This study is a multi-centre, prospective, open-label, single-arm study. Adult patients with mild or moderate acute respiratory distress syndrome (ARDS) requiring mechanical ventilation were planned to receive ultra-lung protective ventilation (ULPV) associated with ECCO2R using PrismaLung+. The study will assess the capability of PrismaLung+ to allow ULPV, defined as a tidal volume (VT) of 4 mL/kg of predicted body weight, and confirm the safety of PrismaLung+.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Patient age is ≥ 18 years old
✓. Patient is expected to receive ECCO2R for a minimum of 24 hours
✓. Patient has mild or moderate ARDS according to the Berlin definition:
✓. Written informed consent to participate in the study from the patient, if possible, or from the identified authorized representative if the patient is unable to provide consent.
Exclusion criteria
✕. Patients body weight \< 30 kg
✕. Patients with a contraindication for systemic anticoagulation with heparin
✕. Patients with a platelet count \< 50,000/µL
✕. Patients on MV \> 7 days
✕. Patients with very severe, or stage 4 (as per GOLD staging System) chronic obstructive pulmonary disease (COPD)
✕. Current or history of heparin-induced thrombocytopenia
What they're measuring
1
Number of participants achieving ultra-lung protective ventilation (ULPV) 8 and 24 hours following ECCO2R initiation
Timeframe: 8 and 24 hours following ECCO2R initiation