Patients With Severe Acute Exacerbation of COPD Ans Admitted in ICU Register.
COPDregister
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.
1 other identifier
observational
2,000
1 country
2
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2022
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2022
CompletedFirst Submitted
Initial submission to the registry
February 6, 2024
CompletedFirst Posted
Study publicly available on registry
February 13, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2028
February 13, 2024
February 1, 2024
5 years
February 6, 2024
February 6, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
the epidemiological, clinical and biological characteristics of patients admitted to the ICU for a severe acute exacerbation of COPD
to describe the epidemiological, clinical and biological characteristics of patients admitted to the ICU for a severe acute exacerbation of COPD
5 year
Interventions
Multicentre prospective observational register
Eligibility Criteria
patients with severe acute exacerbation of COPD admitted in ICU
You may qualify if:
- 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
You may not qualify if:
- Known asthma (according to the criteria of the international "Global initiative for asthma" guidelines)
- Patient refusal to participate (information note, application for non-opposition)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alexis FERRElead
Study Sites (2)
Centre hospitalier de Versailles
Le Chesnay, 78157, France
CH Le Mans
Le Mans, 72037, France
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 5 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- coordinating investigator
Study Record Dates
First Submitted
February 6, 2024
First Posted
February 13, 2024
Study Start
October 1, 2022
Primary Completion (Estimated)
October 1, 2027
Study Completion (Estimated)
April 1, 2028
Last Updated
February 13, 2024
Record last verified: 2024-02