Low-Flow CO2 Removal for Mild to Moderate ARDS With PRISMALUNG

Groupe Hospitalier Pitie-Salpetriere

Status: Completed

Conditions: Acute Respiratory Distress Syndrome

Treatments: Device: CO2 removal with PRISMALUNG in ARDS

Study type: Observational

Funder types: Other

Identifiers

NCT02606240

PSL-AC-11-11-15

Details and patient eligibility

About

This pilot observational study will assess changes in pH /PaO2 /PaCO2, Respiratory Rate and device CO2 clearance in the first 24 hours of Extracorporeal CO2 removal (ECCO2R) following tidal volume (Vt), and plateau pressure reduction in patients with mild to moderate ARDS.

Full description

Extracorporeal CO2 removal (ECCO2R) with a low-flow CO2 removal device (Prismalung, Gambro-Baxter) integrated on the Prismaflex platform (Gambro-Baxter) allows tidal volume (Vt) and plateau pressure reduction in patients with mild to moderate ARDS. This pilot observational study will assess changes in pH /PaO2 /PaCO2, Respiratory Rate and device CO2 clearance in the first 24 hours of ECCO2R following Vt and plateau pressure reduction in patients with mild to moderate ARDS. Safety variables during treatment will also be analyzed. A series of 20 consecutive patients will be included in this observational study.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Mechanical ventilation with expected duration of >24 hours
• Mild to moderate Acute Respiratory Distress Syndrome (ARDS) according to the Berlin definition: 100 mmHg <PaO2/FiO2 <300 mmHg, with PEEP > 5 cmH2O

Exclusion criteria

• Age <18 years
• Pregnancy
• Severe hypoxemia with PaO2/FiO2 <100 mmHg
• Body mass index > 40 kg/m2
• Decompensated heart insufficiency or acute coronary syndrome
• Severe Chronic obstructive pulmonary disease (COPD)
• Major respiratory acidosis with PaCO2 >60 mmHg
• Acute brain injury
• Severe liver insufficiency (Child-Pugh scores >7) or fulminant hepatic failure
• Heparin-induced thrombocytopenia
• Contraindication for systemic anticoagulation
• Patient moribund, decision to limit therapeutic interventions
• Catheter access to femoral vein or jugular vein impossible
• Pneumothorax
• Platelet <50 G/L
• Lacking consent

Trial design

20 participants in 1 patient group

Mild to Moderate ARDS on PRISMALUNG

Description:

Extracorporeal CO2 removal (ECCO2R) with the PRISMALUNG device in patients with mild to moderate Acute Respiratory Distress Syndrome (ARDS).

Treatment:

Device: CO2 removal with PRISMALUNG in ARDS