ow-flow extracorporeal CO2 removal in patients with moderate ARDS to enhance lung protective ventilation. Pilot feasibility and safety study

Completed

Conditions: ARDS
shock lung
10024967

Registration Number: NL-OMON43868

Lead Sponsor: European Society of Intensive Care Medicine (ESICM)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 10

Inclusion Criteria

- moderately severe ARDS according to the Berlin definition(16);PaO2/FiO2: 200-100 mmHg, with PEEP * 5 cmH2O
- expected duration of ventilation >24h

Exclusion Criteria

- Age <18 years
- Pregnancy
- Decompensated heart insufficiency or acute coronary syndrome - Severe COPD
- Major respiratory acidosis PaCO2>60 mmHg
- Acute brain injury
- Severe liver insufficiency (Child-Pugh scores >7) or fulminant hepatic failure
- Heparin-induced thrombocytopenia (HIT)
- 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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Achievement of reduction of tidal volume size till 4ml/kg, while maintaining pH<br /><br>and PaCO2 within 20% of that with ventilation with tidal volumes of 6ml/kg.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Changes in acidity, oxygen tension, carbon dioxide tension and device CO2<br /><br>clearance in the first 24 hours of ECCO2R following tidal volume reduction from<br /><br>normal to low. <br /><br>- Changes in respiratory parameters (tidal volume, ventilation pressure and<br /><br>respiratory rate)<br /><br>- Amount of CO2 removed by the ECCO2R device<br /><br>- Lifetime of the extracorporeal circulation<br /><br>- Device related complications</p><br>