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ACTIVE NOT RECRUITING
NCT05546606
NA

CO2 Removal in Severe Acute exacerbatIons of Chronic Obstructive Lung Diseases

Sponsor: Assistance Publique - Hôpitaux de Paris

View on ClinicalTrials.gov

Summary

The aim of the study is to determine which standard of care strategy will best benefit very severe Acute Exacerbation (AE) of Chronic Obstructive Pulmonary Disease (COPD), single versus reinforced with ECCO2R and assess the respective efficacy and the safety. Very severe AE of COPD will be defined by high risk of Non-Invasive Ventilation (NIV) failure defined by need of intubation and/or in-Intensive Care Unit (ICU) mortality (Stratum 1) or by Invasive Mechanical Ventilation (IMV) after NIV failure and/or with severe hyperinflation and hypercapnia (Stratum 2).

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

17

Start Date

2023-04-18

Completion Date

2025-03-11

Last Updated

2024-08-05

Healthy Volunteers

No

Interventions

DEVICE

ECCO2R

ECCO2R therapy using the Xenios platform, CE-marked medical device of the firm Xenios AG (Heilbronn, Germany), including the following components: Xenios console, iLA active iLA Kit IPS and Novaport Twin (18Fr, 22Fr or 24 Fr) cannulas The maximal duration of ECCO2R therapy with one circuit will be of 29 days in agreement with the regulatory approval of the patient kit.

Locations (20)

CHU Angers

Angers, France

CHU Besançon

Besançon, France

Hôpital Avicennes, AP-HP

Bobigny, France

CHD de Vendée

La Roche-sur-Yon, France

CH Le Mans

Le Mans, France

Hôpital de la Croix-Rousse

Lyon, France

Hôpital Nord

Marseille, France

CHU Lapeyronie

Montpellier, France

CHR Orléans

Orléans, France

Hôpital La Pitié Salpêtrière, AP-HP

Paris, France

Hôpital Cochin - APHP

Paris, France

Hôpital européen Georges Pompidou - APHP

Paris, France

Hôpital Tenon

Paris, France

CHU la Milétrie

Poitiers, France

CHU Pontchaillou

Rennes, France

CHU Rouen

Rouen, France

Centre Hospitalier de Saint Denis

Saint-Denis, France

Nouvel Hôpital Civil Strasbourg

Strasbourg, France

CHRU Bretonneau

Tours, France

Hôpital d'Instruction des Armées Robert Picqué

Villenave-d'Ornon, France