SUPERNOVA: A Strategy of UltraProtective lung ventilation With Extracorporeal CO2 Removal for New-Onset moderate to seVere ARDS
Q&A
Rationale
ARDSnet strategy might not protect against tidal hyperinflation
- When Pplat remains >28-30 cm H2O
Further decrease of Vt
- From 6 to 5, 4 or 3 ml/kg IBW
- To decrease Pplat <25 cm H2O, To decrease delta P
- To further reduce VILI
- With sufficient PEEP to prevent lung derecruitment
Induced hypercapnia controlled by extracorporeal CO2 removal
- “CO2 dialysis”
- Low-flow devices
PILOT trial
Feasibility and safety
100 patients
3 devices (MAQUET, NOVALUNG, ALUNG)
Starting date: Autumn 2015
RCT
The aim is to randomise up to 1500 patients
There will be an adaptive design
The protocol will be finalised according to the results of the pilot trial
Study Objectives
Extracorporeal CO2(ECCO2R) removal devices (PALP, MAQUET; ILA-active, NOVALUNG; Hemolung, ALung) allowVT and plateau pressure reduction in patients with moderate ARDS. This 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 moderate ARDS. Safety variables during treatment will also be analysed.
Research protocol
- Study design: We plan to prospectively collect data on 100 patients during usual care in 21 centers.
- Study devices: PALP, MAQUET; ILA-active, NOVALUNG; Hemolung, ALung. All devices are CE-marked in the European Union.
How do I participate?
A selection of ICUs will take part in the pilot study (approx. 20)
Documents
• Supernova steering committee
• Protocol
Contact
For more information, please contact supernova@esicm.org
