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NCT Number: NCT06257329

Patients With Severe Acute Exacerbation of COPD Ans Admitted in ICU Register.

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

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Key information

Conditions

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre hospitalier de Versailles, Le Chesnay, France

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

register

Other

Multicentre prospective observational register

Primary outcomes

  1. 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 contacts

Contact information is provided by the study sponsor or research team.

alexis ferre

CONTACT

[email protected]

+33.1.39.63.88.37

virginie chatagner

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Alexis FERRE

Other

Registry information

Official study 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.

Acronym: COPDregister

Important dates

Study start
2022
Primary completion
2027
Study completion
2028
First posted
Feb 13, 2024
Registry last updated
Feb 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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