Ignite Creation Date:
2024-05-06 @ 8:05 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06257329
Status:
RECRUITING
Last Update Posted:
2024-02-13
First Post:
2024-02-06
Brief Title:
Patients With Severe Acute Exacerbation of COPD Ans Admitted in ICU Register
Sponsor:
Alexis FERRE
Organization:
Versailles Hospital
Study Overview
Official Title:
Epidemiological Clinical and Biological Characteristics and Therapeutic Management of ICU Patients With Severe Acute Exacerbation of COPD Evaluation of Prognosis and Factors Associated With Survival
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COPDregister
Brief Summary:
The objective of this prospective observational study is to describe the epidemiological clinical and biological characteristics of admitted patients in ICU for severe acute exacerbation of COPD to assess the different therapeutics used to evaluate the prognosis of patients with short medium and long term 1 year and the various factors associated with survival in ICU
Detailed Description:
This is a prospective study for which data will be collected from pseudonymised General information on the research activity clinic of the Intensive Care Service of the CH of Versailles is provided by poster patient booklet or debrief hospitalization indicating to relatives and or patients their possible participation in retrospective or prospective studies
This research is conducted in accordance with the reference methodology MR 004 approved by the National Commission of Informatics and Libertés CNIL and to which the Centre hospitalier de Versailles is committed to comply For this purpose an information note will be given to each patient participating in this project in order to seek its non-opposition of participation in this study
This prospective study is based solely on the examination of files medical The data collected are only non-sensitive medical data
This study complies with legal and regulatory requirements In addition this research project was submitted to the Ethics Committee EC of the Société de Réanimation de Langue Française SRLF who gave an opinion favorable on 06102022 Registration number referenced CE SRLF 22- 056
This research is conducted in accordance with the reference methodology MR 004 approved by the National Commission of Informatics and Libertés CNIL and to which the Centre hospitalier de Versailles is committed to comply For this purpose an information note will be given to each patient participating in this project in order to seek its non-opposition of participation in this study
This prospective study is based solely on the examination of files medical The data collected are only non-sensitive medical data
This study complies with legal and regulatory requirements In addition this research project was submitted to the Ethics Committee EC of the Société de Réanimation de Langue Française SRLF who gave an opinion favorable on 06102022 Registration number referenced CE SRLF 22- 056
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None