Observing patients with severe COPD exacerbations in the ICU
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.
This study looks at patients with severe COPD flare-ups in the ICU to learn more about their health, treatments, and chances of recovery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | Versailles Hospital Academic / other |
| Locations | 2 sites (Le Chesnay and 1 other locations) |
| Trial ID | NCT06257329 on ClinicalTrials.gov |
What this trial studies
This prospective observational study aims to describe the epidemiological, clinical, and biological characteristics of patients admitted to the ICU for severe acute exacerbations of COPD. It will assess the various therapeutic approaches used and evaluate patient prognosis over short, medium, and long-term periods, including factors associated with survival in the ICU. Data will be collected from pseudonymized medical files, ensuring compliance with legal and ethical standards. The study has received favorable ethical approval and aims to enhance understanding of COPD exacerbations in critical care settings.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 40 and older with documented or suspected COPD who are experiencing a severe acute exacerbation requiring ICU admission.
Not a fit: Patients with known asthma or those who refuse to participate will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve treatment strategies and outcomes for patients experiencing severe COPD exacerbations.
How similar studies have performed: While this study follows a common observational approach, the specific focus on severe COPD exacerbations in ICU settings may provide novel insights, as similar studies have shown varying degrees of success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age ≥ 40 years old 2. 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) 3. 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) 4. Admission to an ICU, a step-up unit or a respiratory care unit Exclusion Criteria: 1. Known asthma (according to the criteria of the international "Global initiative for asthma" guidelines) 2. Patient refusal to participate (information note, application for non-opposition)
Where this trial is running
Le Chesnay and 1 other locations
- Centre hospitalier de Versailles — Le Chesnay, France (Recruiting)
- CH Le Mans — Le Mans, France (Recruiting)
Study contacts
- Study coordinator: alexis ferre
- Email: aferre@ght78sud.fr
- Phone: +33.1.39.63.88.37
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.