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

NCT02965079 | Unknown

• 1 other identifier: APHP
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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. 1.to assess efficacy and safety of ECCO2R,
2. 2.to compare the data issue from the registry to others studies assessing the same population and to other centers and
3. 3.to compare the different ECCOR devices in terms of efficacy and adverse events.

Conditions

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

Keywords

extracorporeal CO2 removal; registry; COPD and ARDS; CEDIT on behalf of APHP

Outcome Measures

Primary Outcomes (1)

• Incidence of ECCO2R use

  Number of ECCO2R implantation monthly by center

  Recorded monthly up to 100 weeks (24 months)

Secondary Outcomes (6)

• 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

Interventions

ECCO2R DEVICE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

3 types of patients : Patients with acute exacerbation of chronic obstructive pulmonary disease (COPD) and acute hypercapnic respiratory failure at high risk to failed noninvasive ventilation Patients with acute exacerbation of chronic obstructive pulmonary disease (COPD) needing invasive ventilation in order to reduce mechanical ventilation duration Patients with ARDS and with the ail to reduce ventilation

You may qualify if:

• Patients implanted with ECCCO2R

You may not qualify if:

• Contra-indication to ECCO2R

Sponsors & Collaborators

• Rexecor: lead

Study Sites (1)

Assistance Publique - Hopitaux de Paris

Paris, 75015, France

RECRUITING

Related Publications (1)

• Augy JL, Aissaoui N, Richard C, Maury E, Fartoukh M, Mekontso-Dessap A, Paulet R, Anguel N, Blayau C, Cohen Y, Chiche JD, Gaudry S, Voicu S, Demoule A, Combes A, Megarbane B, Charpentier E, Haghighat S, Panczer M, Diehl JL. A 2-year multicenter, observational, prospective, cohort study on extracorporeal CO2 removal in a large metropolis area. J Intensive Care. 2019 Aug 20;7:45. doi: 10.1186/s40560-019-0399-8. eCollection 2019.

  PMID: 31452899 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jean-Luc Diehl, MD

CONTACT

0033156093201; jean-luc.diehl@aphp.fr

Nadia Aissaoui, MD

CONTACT

0033156093201; nadia.aissaoui@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2016
• First Posted: November 16, 2016
• Study Start: January 1, 2016
• Primary Completion: January 1, 2022
• Study Completion: June 1, 2022
• Last Updated: October 14, 2020

Record last verified: 2020-09

Locations

FR (1)