Observational registry for COPD patients in ICU

Epidemiological, Clinical and Biological Characteristics and Therapeutic Management of ICU Patients With Severe Acute Exacerbation of COPD. Evaluation of the Prognosis and the Factors Associated With Survival Multicentre Prospective Observational Register

This study is looking at patients with severe COPD who are in the ICU to see how they are treated and what happens to them, in hopes of improving care for future patients.

Quick facts

• Study type: Observational
• Enrollment: 500 (estimated)
• Ages: 40 Years and up
• Sex: All
• Sponsor: Versailles Hospital (other)
• Locations: 1 site (Le Chesnay)
• Trial ID: NCT05734365 on ClinicalTrials.gov

What this trial studies

This observational registry focuses on patients with acute exacerbations of Chronic Obstructive Pulmonary Disease (COPD) who are admitted to an Intensive Care Unit (ICU). It aims to document the clinical characteristics, treatment approaches, and outcomes of these patients to better understand the severity and management of COPD exacerbations. By collecting data from multiple centers, the study seeks to highlight the socio-economic impact of COPD and the burden of exacerbations on healthcare systems. The findings may inform future clinical practices and guidelines for managing severe COPD cases.

Who should consider this trial

Good fit: Ideal candidates for this study are adults 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 lead to improved management strategies for patients experiencing severe COPD exacerbations, potentially reducing mortality and healthcare costs.

How similar studies have performed: Other studies have shown success in documenting and managing COPD exacerbations, indicating that this approach is supported by existing research.

Eligibility 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 syndrome (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, or a dedicated respiratory intensive 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

• Centre hospitalier de Versailles — Le Chesnay, France (RECRUITING)

Study contacts

• Principal investigator: Alexis Ferré, MD — Centre hospitalier de Versailles, 78150, Le Chesnay
• Study coordinator: Alexis Ferré, MD

Conditions: COPD Exacerbation Acute