Extracorporeal carbon dioxide removal for treatment of exacerbated chronic obstructive pulmonary disease (ORION): study protocol for a randomised controlled trial.
Acute exacerbations of chronic obstructive pulmonary disease
COPD
ECCO2R
Extracorporeal CO2 removal
NIV
Non-invasive ventilation
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
19 Oct 2021
19 Oct 2021
Historique:
received:
12
04
2021
accepted:
07
10
2021
entrez:
20
10
2021
pubmed:
21
10
2021
medline:
24
10
2021
Statut:
epublish
Résumé
Hypercapnic exacerbations are severe complications of chronic obstructive pulmonary disease (COPD), characterized by negative impact on prognosis, quality of life and healthcare costs. The present standard of care for acute exacerbations of COPD is non-invasive ventilation; when it fails, the use of invasive mechanical ventilation is inevitable, but is associated with extremely poor prognosis. Extracorporeal circuits designed to remove CO multicenter randomized controlled unblinded clinical trial including 284 (142 per arm) patients with acute hypercapnic respiratory failure caused by exacerbation of COPD, requiring respiratory support with NIV. The primary outcome is event free survival at 28 days, a composite outcome defined by survival in absence of prolonged mechanical ventilation, severe hypoxemia, septic shock and second episode of COPD exacerbation. Secondary outcomes are incidence of endotracheal intubation and tracheostomy, intensive care and hospital length-of-stay and 90-day mortality. Acute exacerbations of COPD represent a significant burden in terms of prognosis, quality of life and healthcare costs. Lack definite evidence despite increasing use of ECCO ClinicalTrials.gov , NCT04582799 . Registered 12 October 2020, .
Sections du résumé
BACKGROUND
BACKGROUND
Hypercapnic exacerbations are severe complications of chronic obstructive pulmonary disease (COPD), characterized by negative impact on prognosis, quality of life and healthcare costs. The present standard of care for acute exacerbations of COPD is non-invasive ventilation; when it fails, the use of invasive mechanical ventilation is inevitable, but is associated with extremely poor prognosis. Extracorporeal circuits designed to remove CO
METHODS
METHODS
multicenter randomized controlled unblinded clinical trial including 284 (142 per arm) patients with acute hypercapnic respiratory failure caused by exacerbation of COPD, requiring respiratory support with NIV. The primary outcome is event free survival at 28 days, a composite outcome defined by survival in absence of prolonged mechanical ventilation, severe hypoxemia, septic shock and second episode of COPD exacerbation. Secondary outcomes are incidence of endotracheal intubation and tracheostomy, intensive care and hospital length-of-stay and 90-day mortality.
DISCUSSION
CONCLUSIONS
Acute exacerbations of COPD represent a significant burden in terms of prognosis, quality of life and healthcare costs. Lack definite evidence despite increasing use of ECCO
TRIAL REGISTRATION
BACKGROUND
ClinicalTrials.gov , NCT04582799 . Registered 12 October 2020, .
Identifiants
pubmed: 34666820
doi: 10.1186/s13063-021-05692-w
pii: 10.1186/s13063-021-05692-w
pmc: PMC8524839
doi:
Substances chimiques
Carbon Dioxide
142M471B3J
Banques de données
ClinicalTrials.gov
['NCT04582799']
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
718Subventions
Organisme : Ministero dell'Istruzione, dell'Università e della Ricerca
ID : 2017J4BE7A
Informations de copyright
© 2021. The Author(s).
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