ClinConnect ClinConnect Logo
Search / Trial NCT02606240

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

Launched by GROUPE HOSPITALIER PITIE-SALPETRIERE · Nov 13, 2015

Trial Information

Current as of April 26, 2025

Completed

Keywords

ClinConnect Summary

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 o...

Gender

ALL

Eligibility criteria

  • 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

About Groupe Hospitalier Pitie Salpetriere

Groupe Hospitalier Pitié-Salpêtrière is a leading academic medical center located in Paris, France, renowned for its commitment to advancing healthcare through innovative research and clinical trials. As part of the Assistance Publique – Hôpitaux de Paris network, the institution integrates patient care, education, and research to address complex medical challenges across a wide range of specialties. With a robust infrastructure for clinical research and a multidisciplinary team of experts, the Groupe Hospitalier Pitié-Salpêtrière is dedicated to improving patient outcomes and contributing to the global medical community through rigorous scientific inquiry and collaboration.

Locations

Amiens, , France

Besançon, , France

Clermont Ferrand, , France

Montpellier, , France

Paris, , France

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Similar Trials