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| Name | Class |
|---|---|
| Centre Hospitalier Universitaire, Amiens | OTHER |
| Centre Hospitalier Universitaire de Besancon | OTHER |
| University Hospital, Clermont-Ferrand | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Mild to Moderate ARDS according to the Berlin definition of ARDS
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU AMIENS, Département Anesthésie Réanimation | Amiens | France | ||||
| CHU Besançon, Réanimation |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29743094 | Derived | 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. |
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| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
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| University Hospital, Montpellier |
| OTHER |
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|
| 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 |
| Besançon |
| France |
| CHU CLERMONT FERRAND, Département Anesthésie Réanimation | Clermont-Ferrand | France |
| CHU MONTPELLIER, Département Anesthésie Réanimation | Montpellier | France |
| Hopital Pitié Salpetriere, Reanimation Medicale | Paris | 75013 | France |