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.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,000
- 试验地点
- 2
- 主要终点
- the epidemiological, clinical and biological characteristics of patients admitted to the ICU for a severe acute exacerbation of COPD
研究概览
简要总结
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
详细描述
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Known asthma (according to the criteria of the international "Global initiative for asthma" guidelines)
- •Patient refusal to participate (information note, application for non-opposition)
结局指标
主要结局
the epidemiological, clinical and biological characteristics of patients admitted to the ICU for a severe acute exacerbation of COPD
时间窗: 5 year
to describe the epidemiological, clinical and biological characteristics of patients admitted to the ICU for a severe acute exacerbation of COPD
次要结局
未报告次要终点
研究者
Alexis FERRE
coordinating investigator
Versailles Hospital