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

Groupe Hospitalier Pitie-Salpetriere20 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

Conditions

Acute Respiratory Distress Syndrome

Interventions

CO2 removal with PRISMALUNG in ARDSDEVICE

Observational study of patients with mild to moderate Acute Respiratory Distress Syndrome (ARDS) submitted to Extracorporeal CO2 removal (ECCO2R) with the PRISMALUNG device to allow ultraprotective mechanical ventilation with tidal volume reduction (from 6 to 4 ml/kg, predicted body weight) and plateau pressure reduction from 28-30 to 23-25 cmH2O.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (5)

CHU AMIENS, Département Anesthésie Réanimation

Amiens, France

CHU Besançon, Réanimation

Besançon, France

CHU CLERMONT FERRAND, Département Anesthésie Réanimation

Clermont-Ferrand, France

CHU MONTPELLIER, Département Anesthésie Réanimation

Montpellier, France

Outcomes

Primary Outcomes

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.

Time frame: 24 hours

Secondary Outcomes

Assessment of changes in Vt

Time frame: 24 hours

Assessment of changes in Plateau Pressure

Time frame: 24 hours

Assessment of changes in respiratory rate

Time frame: 24 hours

Assessment of changes in Positive End-Expiratory Pressure, PEEP

Time frame: 24 hours

Change in vasopressor use

Epineprine and norepinephine dose, mcg/kg/min

Time frame: 24 hours

Evaluation of lung recruitment/derecruitment

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

Time frame: 24 hours

Lifetime of the extracorporeal circulation

In hours

Data from ClinicalTrials.gov

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