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

Completed

• Conditions: Acute Respiratory Distress Syndrome
• Interventions: Device: CO2 removal with PRISMALUNG in ARDS

• Registration Number: NCT02606240
• Lead Sponsor: Groupe Hospitalier Pitie-Salpetriere

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2015-11-11
• Study First Submitted QC: 2015-11-13
• Study First Posted: 2015-11-17
• Study Start: 2016-03
• Primary Completion: 2017-06
• Study Completion: 2017-06
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-05
• Last Update Posted: 2017-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Mild to Moderate ARDS on PRISMALUNG	CO2 removal with PRISMALUNG in ARDS	Extracorporeal CO2 removal (ECCO2R) with the PRISMALUNG device in patients with mild to moderate Acute Respiratory Distress Syndrome (ARDS).

Primary Outcome Measures

Name	Time	Method
Number of participants who achieved a tidal volume (Vt) reduction to 4 mL/kg while maintaining pH and PaCO2 to ± 20% of baseline values obtained at Vt of 6 mL/kg.	24 hours	Number of participants who achieved a tidal volume (Vt) reduction to 4 mL/kg while maintaining pH and PaCO2 to ± 20% of baseline values obtained at Vt of 6 mL/kg.

Secondary Outcome Measures

Name	Time	Method
Assessment of changes in respiratory rate	24 hours	Assessment of changes in respiratory rate
Assessment of changes in Vt	24 hours	Assessment of changes in Vt
Assessment of changes in Plateau Pressure	24 hours	Assessment of changes in Plateau Pressure
Assessment of changes in Positive End-Expiratory Pressure, PEEP	24 hours	Assessment of changes in Positive End-Expiratory Pressure, PEEP
Change in vasopressor use	24 hours	Epineprine and norepinephine dose, mcg/kg/min
Evaluation of lung recruitment/derecruitment	24 hours	With lung echography. Ccording to the method described by Bouhemad et al, Am J Respir Crit Care Med. 2011 Feb 1;183(3):341-7
Lifetime of the extracorporeal circulation	7 days	In hours
Number of participants with adverse events directly related to ECCO2R	7 days	Adverse events directly related to ECCO2R are hemolysis (serum free hemoglobin \>500 mg/L), infection at the cannulation site, Hemorrhage at the cannulation site, air entry in the circuit.

Trial Locations

Locations (5)

CHU AMIENS, Département Anesthésie Réanimation; 🇫🇷 Amiens, France

CHU Besançon, Réanimation; 🇫🇷 Besançon, France

CHU CLERMONT FERRAND, Département Anesthésie Réanimation; 🇫🇷 Clermont Ferrand, France

Hopital Pitié Salpetriere, Reanimation Medicale; 🇫🇷 Paris, France

CHU MONTPELLIER, Département Anesthésie Réanimation; 🇫🇷 Montpellier, France