Registry on the EXperience of Extracorporeal CO2 Removal in Intensive Care Units

Study Overview
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Brief Summary
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Investigators will aim to conduct an observational study in order to assess very thoroughly all patients implanted by Extracorporeal carbon dioxide removal (ECCO2R) in 10 critical care units of Paris and its surburb (APHP, Assistance Publique des hôpitaux de Paris). Secondary objectives will be: to assess efficacy and safety of ECCO2R, to compare the data issue from the registry to others studies assessing the same population and to other centers and to compare the different ECCOR devices in terms of efficacy and adverse events.

Detailed Description
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The registry will be conducted prospectively during 2 years in 10 ICUs of l'APHP on behalf on the CEDIT. The 10 centers are : (1) ICU of l'hôpital europeén Georges Pompidou, (2) ICU of l'Hôpital Louis Mourier, (3) ICU of l'Hôpital de Bicêtre, (4) ICU of GHPS, (5) Respiratory ICU of GHPS, (6) ICU of l'Hôpital Lariboisière (7) ICU of l'Hôpital Cochin (8) ICU of l'Hôpital Saint-Antoine (9)ICU of l'Hôpital Henri Mondor and (10) ICU of l'Hôpital Tenon. The primary outcome will be the number of patients implanted by ECCO2R monthly in each center during the 2 years period study. Secondary outcomes will be ICU-mortality, invasive ventilation duration, non invasive ventilation duration, ICU duration, modalities of ventilation at the ICU discharge, hemorragic complications due to the ECCOR device, thrombotic complications due to ECCO2R device, intravascular hemolysis due to ECCO2R device, duration of ECCO2R, adjunct therapy to ECCO2R and reasons of ECCO2R discontinuation.

Official Title
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Registry on the EXperience of Extracorporeal CO2 Removal in Intensive Care Units

Conditions
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Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease, Patients With Acute Respiratory Distress Syndrome

Intervention / Treatment
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* Device: ECCO2R


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients implanted with ECCCO2R Exclusion Criteria: Contra-indication to ECCO2R

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: ECCO2R|The ECCO2R system was developed from the principle of ECMO systems by underscoring the importance of carbon dioxide elimination rather than direct improvement of oxygenation in some patients. The circuit of the ECCO2R system can be set up in venovenous (VV) or arteriovenous (AV). For VV setup, a low flow pump is used to maintain a low extracorporeal flow rate using only 20-30 % of cardiac output. The ECCO2R system does not provide complete pulmonary function as it can achieve only limited oxygenation but provides predominantly carbon dioxide removal. As neither VV nor AV circuit allows full cardiopulmonary bypass, the system provides respiratory function but no cardiac support|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of ECCO2R use | Number of ECCO2R implantation monthly by center | Recorded monthly up to 100 weeks (24 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICU mortality |  | Recorded From date of ICU admission until the date of death or ICU discharge, assessed up to 100 weeks | 
| Duration of mechanical ventilation |  | Recorded from ICU admission until the date of death or ICU discharge,assessed up to 100 weeks | 
| ICU duration |  | Recorded from ICU admission until the date of death or ICU discharge,assessed up to 100 weeks | 
| Ventilation modalities at discharge |  | Recorded from the initiation of ventilation until ventilation removal,assessed up to 100 weeks | 
| hemorragic and thrombotic complications |  | Recorded from the date of ECCO2R implantation until the removal of the device,assessed up to 100 weeks | 
| hemolysis |  | Recorded from the date of ECCO2R implantation until the removal of the device,assessed up to 100 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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extracorporeal CO2 removal, registry, COPD and ARDS, CEDIT on behalf of APHP