Low-Flow CO2 Removal for Mild to Moderate ARDS With PRISMALUNG
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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 Design
Arms and Interventions
| Arm | 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.
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Outcome Measures
Primary Outcome Measures
- 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
- 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 respiratory rate [24 hours]
Assessment of changes in respiratory rate
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Mechanical ventilation with expected duration of >24 hours
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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:
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Age <18 years
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Pregnancy
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Severe hypoxemia with PaO2/FiO2 <100 mmHg
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Body mass index > 40 kg/m2
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Decompensated heart insufficiency or acute coronary syndrome
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Severe Chronic obstructive pulmonary disease (COPD)
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Major respiratory acidosis with PaCO2 >60 mmHg
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Acute brain injury
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Severe liver insufficiency (Child-Pugh scores >7) or fulminant hepatic failure
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Heparin-induced thrombocytopenia
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Contraindication for systemic anticoagulation
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Patient moribund, decision to limit therapeutic interventions
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Catheter access to femoral vein or jugular vein impossible
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Pneumothorax
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Platelet <50 G/L
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Lacking consent
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CHU AMIENS, Département Anesthésie Réanimation | Amiens | France | ||
| 2 | CHU Besançon, Réanimation | Besançon | France | ||
| 3 | CHU CLERMONT FERRAND, Département Anesthésie Réanimation | Clermont Ferrand | France | ||
| 4 | CHU MONTPELLIER, Département Anesthésie Réanimation | Montpellier | France | ||
| 5 | Hopital Pitié Salpetriere, Reanimation Medicale | Paris | France | 75013 |
Sponsors and Collaborators
- Groupe Hospitalier Pitie-Salpetriere
- Centre Hospitalier Universitaire, Amiens
- Centre Hospitalier Universitaire de Besancon
- University Hospital, Clermont-Ferrand
- University Hospital, Montpellier
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PSL-AC-11-11-15