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

Extracorporeal CO2 Removal (ECCO2R) With a Renal Replacement Platform (PRISMALUNG) to Enhance Lung Protective Ventilation in Patients With Mild to Moderate Acute Respiratory Distress Syndrome (ARDS)

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.

Study Overview

• Status: Completed
• Conditions: Acute Respiratory Distress Syndrome
• Intervention / Treatment: Device: CO2 removal with PRISMALUNG in 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 Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• France
  • Amiens, France
    • CHU AMIENS, Département Anesthésie Réanimation
  • Besançon, France
    • CHU Besançon, Réanimation
  • Clermont Ferrand, France
    • CHU CLERMONT FERRAND, Département Anesthésie Réanimation
  • Montpellier, France
    • CHU MONTPELLIER, Département Anesthésie Réanimation
  • Paris, France, 75013
    • Hopital Pitié Salpetriere, Reanimation Medicale

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Mild to Moderate ARDS according to the Berlin definition of ARDS

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Mild to Moderate ARDS on PRISMALUNG; Extracorporeal CO2 removal (ECCO2R) with the PRISMALUNG device in patients with mild to moderate Acute Respiratory Distress Syndrome (ARDS).	Device: CO2 removal with PRISMALUNG in ARDS; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of changes in Vt	Assessment of changes in Vt	24 hours
Assessment of changes in Plateau Pressure	Assessment of changes in Plateau Pressure	24 hours
Assessment of changes in respiratory rate	Assessment of changes in respiratory rate	24 hours
Assessment of changes in Positive End-Expiratory Pressure, PEEP	Assessment of changes in Positive End-Expiratory Pressure, PEEP	24 hours
Change in vasopressor use	Epineprine and norepinephine dose, mcg/kg/min	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	24 hours
Lifetime of the extracorporeal circulation	In hours	7 days
Number of participants with adverse events directly related to ECCO2R	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.	7 days

Collaborators and Investigators

• Sponsor: Groupe Hospitalier Pitie-Salpetriere
• Collaborators: Centre Hospitalier Universitaire, Amiens; University Hospital, Montpellier; University Hospital, Clermont-Ferrand; Centre Hospitalier Universitaire de Besancon

Publications and helpful links

General Publications

• Schmidt M, Jaber S, Zogheib E, Godet T, Capellier G, Combes A. Feasibility and safety of low-flow extracorporeal CO2 removal managed with a renal replacement platform to enhance lung-protective ventilation of patients with mild-to-moderate ARDS. Crit Care. 2018 May 10;22(1):122. doi: 10.1186/s13054-018-2038-5.

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): June 1, 2017

Study Registration Dates

• First Submitted: November 11, 2015
• First Submitted That Met QC Criteria: November 13, 2015
• First Posted (Estimate): November 17, 2015

Study Record Updates

• Last Update Posted (Actual): August 8, 2017
• Last Update Submitted That Met QC Criteria: August 5, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Disease; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; Syndrome; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• Other Study ID Numbers: PSL-AC-11-11-15

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided