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Clinical Trials/NCT06257329
NCT06257329
Recruiting
Not Applicable

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.

Alexis FERRE2 sites in 1 country2,000 target enrollmentOctober 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
COPD Exacerbation
Sponsor
Alexis FERRE
Enrollment
2000
Locations
2
Primary Endpoint
the epidemiological, clinical and biological characteristics of patients admitted to the ICU for a severe acute exacerbation of COPD
Status
Recruiting
Last Updated
2 years ago

Overview

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 06/10/2022 (Registration number referenced: CE SRLF 22- 056).

Registry
clinicaltrials.gov
Start Date
October 1, 2022
End Date
April 1, 2028
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Alexis FERRE
Responsible Party
Sponsor Investigator
Principal Investigator

Alexis FERRE

coordinating investigator

Versailles Hospital

Eligibility Criteria

Inclusion Criteria

  • Age ≥ 40 years old
  • COPD documented or strongly suspected
  • Chronic respiratory symptoms (dyspnoea, cough and/or sputum)
  • Exposure to a known risk factor for COPD (such as tobacco smoke)
  • If available, respiratory function tests showing non- or partially reversible obstructive syndrom (post-bronchodilator ratio FEV1/CV \< 0.7)
  • Severe acute exacerbation, defined as a worsening of the patient's usual respiratory symptoms with signs of acute respiratory distress (polypnoea ≥ 30 cycles.min-1 or use of accessory respiratory muscles) and/or hypercapnic acidosis (with PaCO2 ≥ 45 mmHg and pH ≤ 7.35)
  • Admission to an ICU, a step-up unit or a respiratory care unit

Exclusion Criteria

  • Known asthma (according to the criteria of the international "Global initiative for asthma" guidelines)
  • Patient refusal to participate (information note, application for non-opposition)

Outcomes

Primary Outcomes

the epidemiological, clinical and biological characteristics of patients admitted to the ICU for a severe acute exacerbation of COPD

Time Frame: 5 year

to describe the epidemiological, clinical and biological characteristics of patients admitted to the ICU for a severe acute exacerbation of COPD

Study Sites (2)

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