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NCT Number: NCT02606240

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

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.

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Key information

Conditions

Acute Respiratory Distress Syndrome Lung Diseases Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU AMIENS, Département Anesthésie Réanimation, Amiens, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CO2 removal with PRISMALUNG in ARDS

Device

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.

Primary outcomes

  1. 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

    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 outcomes

  1. Assessment of changes in Vt

    Time frame: 24 hours

    Assessment of changes in Vt

  2. Assessment of changes in Plateau Pressure

    Time frame: 24 hours

    Assessment of changes in Plateau Pressure

  3. Assessment of changes in respiratory rate

    Time frame: 24 hours

    Assessment of changes in respiratory rate

  4. Assessment of changes in Positive End-Expiratory Pressure, PEEP

    Time frame: 24 hours

    Assessment of changes in Positive End-Expiratory Pressure, PEEP

  5. Change in vasopressor use

    Time frame: 24 hours

    Epineprine and norepinephine dose, mcg/kg/min

  6. Evaluation of lung recruitment/derecruitment

    Time frame: 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

  7. Lifetime of the extracorporeal circulation

    Time frame: 7 days

    In hours

  8. Number of participants with adverse events directly related to ECCO2R

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Groupe Hospitalier Pitie-Salpetriere

Other

Collaborators

  • Centre Hospitalier Universitaire de Besancon
  • Centre Hospitalier Universitaire, Amiens
  • University Hospital, Clermont-Ferrand
  • University Hospital, Montpellier

Registry information

Official study title

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)

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 17, 2015
Registry last updated
Aug 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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