Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease, Patients With Acute Respiratory Distress Syndrome
Conditions
Keywords
extracorporeal CO2 removal, registry, COPD and ARDS, CEDIT on behalf of APHP
Brief summary
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: 1. to assess efficacy and safety of ECCO2R, 2. to compare the data issue from the registry to others studies assessing the same population and to other centers and 3. to compare the different ECCOR devices in terms of efficacy and adverse events.
Detailed description
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.
Interventions
DEVICEECCO2R
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
Sponsors
Rexecor
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Patients implanted with ECCCO2R
Exclusion criteria
* Contra-indication to ECCO2R
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of ECCO2R use | Recorded monthly up to 100 weeks (24 months) | Number of ECCO2R implantation monthly by center |
Secondary
| Measure | 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 |
Countries
France
Contacts
Primary ContactJean-Luc Diehl, MD
Backup ContactNadia Aissaoui, MD
Outcome results
None listed