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NCT Number: NCT05734365

COPD-ICU Multicentre Prospective Observational Register

COPD is one of the leading causes of morbidity, mortality and health care utilisation worldwide. Currently, COPD is the third leading cause of death worldwide and is therefore a major public health problem. Projections show an increase in the prevalence and burden of COPD in the coming decades due to ageing populations and continued exposure to risk factors.

In patients with COPD, mortality due to exacerbations is about 35%. Exacerbations represent the most important respiratory event in the history of this chronic disease and are of major socio-economic interest (about 50-75% of healthcare expenditure in this disease).

In the most severe cases, COPD exacerbations lead to respiratory distress with hypercapnic ventilatory acidosis requiring ventilatory support. These most severe episodes are common, accounting for 20% of exacerbations and are a signal of advanced disease, with a high risk of future hospitalisations and a limited long-term prognosis.

Despite progress in management, the mortality of these severe acute exacerbations is around 15% in the ICU and 20% in hospital. The long-term prognosis following hospitalisation for an acute exacerbation of COPD is poor with a 5-year mortality of around 50%. On the one hand, the means and treatments likely to improve the prognosis of these patients are of great medical and socio-economic interest, on the other hand, it seems important to identify the elements that may be associated with management failure and to treat them where appropriate.

Thus, improving scientific knowledge thanks to prospective data, evaluating the different characteristics and prognosis of patients hospitalised for a severe acute exacerbation of COPD seems, in the 21st century, a major axis in order to continue to optimise the individual management of these patients but also collectively, given the COPD public health burden.

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Key information

Conditions

COPD Exacerbation Acute

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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 syndrome (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, or a dedicated respiratory intensive 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

Primary outcomes

  1. ICU survival

    Time frame: immediately after hospitalization in ICU

    vital status at ICU discharge

  2. Day 90 survival

    Time frame: 90 days after ICU admission

    vital status at day 90

Secondary outcomes

  1. One-year survival

    Time frame: one year after ICU admission

    Rate of survivors and non-survivors will be assessed at one year

    To better understand the one-year survival outcome, numerous factors will be assessed for an association with one-year survival: Demographic characteristics and chronic comorbidities; COPD severity; performans status; chronic use of long term oxygen therapy, systemic steroids or homecare non-invasive ventilation; previous intubation for COPD exacerbation; type of triggering factors of COPD exacerbation; type of treatment used during ICU stay (systemic steroids, intravenous bronchodilators, non-invasive ventilation and invasive ventilation); decision of withholding and withdrawal of care during ICU and hospital stay; further COPD exacerbation between hospital discharge and one year outcome; further COPD exacerbation requiring hospitalization between hospital discharge and one year outcome.

    We will perform descriptive analysis and multivariate analysis with odds ratio for each factor

  2. Factors associated with ICU mortality

    Time frame: immediately after hospitalization in ICU

    Numerous factors will be assessed for an association with ICU mortality: Demographic characteristics and chronic comorbidities; COPD severity; performans status; chronic use of long term oxygen therapy, systemic steroids or homecare non-invasive ventilation; previous intubation for COPD exacerbation; type of triggering factors of COPD exacerbation; vital parameters at ICU admission (temperature, heart rate, mean arterial pressure, respiratory rate, coma glasgow scale); SAPS 2; arterial blood gaz results prameters at ICU admission; biological sample results at ICU admission; type of treatment used during ICU stay (systemic steroids, intravenous bronchodilators, non-invasive ventilation and invasive ventilation).

    We will perform descriptive analysis and multivariate analysis with odds ratio for each factor

  3. Factors associated with hospital mortality

    Time frame: immediately after hospital discharge

    Numerous factors will be assessed for an association with hospital mortality: Demographic characteristics and chronic comorbidities; COPD severity; performans status; chronic use of long term oxygen therapy, systemic steroids or homecare non-invasive ventilation; previous intubation for COPD exacerbation; type of triggering factors of COPD exacerbation; vital parameters at ICU admission (temperature, heart rate, mean arterial pressure, respiratory rate, coma glasgow scale); SAPS 2; arterial blood gaz results prameters at ICU admission; biological sample results at ICU admission; type of treatment used during ICU stay (systemic steroids, intravenous bronchodilators, non-invasive ventilation and invasive ventilation).

    We will perform descriptive analysis and multivariate analysis with odds ratio for each factor

  4. Factors associated with the need for invasive mechanical ventilation

    Time frame: immediately after the intervention named invasive mechanical ventilation

    Numerous factors will be assessed for an association with invasive mechanical ventlation: Demographic characteristics and chronic comorbidities; COPD severity; performans status; chronic use of long term oxygen therapy, systemic steroids or homecare non-invasive ventilation; previous intubation for COPD exacerbation; type of triggering factors of COPD exacerbation; vital parameters at ICU admission (temperature, heart rate, mean arterial pressure, respiratory rate, coma glasgow scale); SAPS 2; arterial blood gaz results prameters at ICU admission; biological sample results at ICU admission; type of treatment before ICU admission (systemic steroids, non-invasive ventilation) and type of treatment used during ICU stay (systemic steroids, intravenous bronchodilators, non-invasive ventilation).

    We will perform descriptive analysis and multivariate analysis with odds ratio for each factor

Study contacts

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

Alexis Ferré, MD

CONTACT

[email protected]

+33139638700

Laure Morisset

CONTACT

[email protected]

+33139239785

Sponsors and collaborators

Lead sponsor

Versailles Hospital

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 the Prognosis and the Factors Associated With Survival Multicentre Prospective Observational Register

Acronym: COPD-ICU

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Feb 17, 2023
Registry last updated
Feb 17, 2023

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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