Skip to main content
OpenTrials
Completed

NCT Number: NCT05682404

Prevalence, Associated Factors Points and Implementation of Care Procedures of Chronic Obstructive Pulmonary Disease Exacerbation in Healthcare Institution

Chronic Obstructive Pulmonary Disease (COPD) is a public health problem responsible for high mortality rate and significant costs for society. The disease evolution is punctuated by exacerbations worsening the health state of patients.

Many guidelines of care procedures have been written but many disparities persist in medical practices.

This pilot prospective observational study is an overview of current local practices in the university health center of Grenoble Alpes and it is the first step towards developing a regional observatory in order to standardize and improve patient cares. The primary outcome is to compare the international guidelines to the local practices regarding the prescription of key treatments of exacerbation, especially antibiotics.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

COPD Exacerbation Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Grenoble Alpes

Grenoble, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient older than 18 years (included)
  • Known or suspected Chronic Obstructive Pulmonary Disease
  • Admitted for COPD exacerbation in emergency department or pneumology department or intensive care unit of university health center of Grenoble Alpes during the period of data collection.

Exclusion criteria

  • opposition to participate at the study
  • Patients under the law

Treatment and study plan

Primary outcomes

  1. Percentage of antibiotics prescriptions following the guidelines in COPD exacerbation.

    Time frame: up to 30 days

    Adherence to guidelines regarding antibiotics prescription in COPD exacerbation that is justified by :

    • sputum purulence
    • severe symptoms
    • severe comorbidities
    • pneumonia

Secondary outcomes

  1. Percentage of corticosteroids prescriptions following the guidelines in COPD exacerbation.

    Time frame: up to 30 days

    Adherence to guidelines regarding corticosteroids prescription in COPD exacerbation that is :

    • not a systematic prescription
    • if needed, it is 30 to 40mg per day of prednisone equivalent and 5 to 7 days maximum

  2. Percentage of hospitalization of patients following the guidelines in COPD exacerbation.

    Time frame: up to 30 days

    Adherence to guidelines regarding hospitalization criteria in COPD exacerbation that are :

    • severe symptoms
    • respiratory failure
    • failure of first treatments
    • severe comorbidities
    • deficient social environment
    • patient older than 85 years old
    • baseline dyspnea around 4 to 5 in Modified Medical Research Council Dyspnea Scale (mMRC scale)

    Adherence to guidelines regarding criteria for intensive care unit hospitalization in COPD exacerbation that are :

    • severe dyspnea not responding to first treatments
    • neurologic troubles
    • persistant hypoxemia despite oxygen administration or Non Invasive Ventilation.
    • respiratory acidosis despite Non Invasive Ventilation
    • need for invasive mechanical ventilation
    • hemodynamic instability and need for aminergic support

  3. Percentage of non invasive ventilation following the guidelines in COPD exacerbation.

    Time frame: up to 30 days

    Adherence to guidelines regarding criteria for non invasive ventilation in COPD exacerbation that are :

    • respiratory acidosis
    • signs of respiratory failure
    • hypoxemia despite oxygen administration
    • absence of medical contraindications

  4. Percentage of invasive ventilation following the guidelines in COPD

    Time frame: up to 30 days

    Adherence to guidelines regarding criteria for invasive ventilation in COPD exacerbation that are :

    • failure of non invasive ventilation
    • medical contraindications for non invasive ventilation
    • cardiac arrest
    • neurologic troubles needing sedation
    • pernicious vomiting
    • ineffective coughing

  5. Percentage of minimal medical examinations following the guidelines in COPD exacerbation.

    Time frame: up to 30 days

    Adherence to guidelines regarding the prescription of minimal medical examinations in COPD exacerbation that is :

    • complete blood count, kidney function, glucose level
    • blood gases
    • chest radiography
    • electrocardiogram
    • bacteriological sputum examination only if antibiotic-resistant germ infection is suspected.

  6. Percentage of follow-up management after COPD exacerbation following the guidelines

    Time frame: up to 30 days

    Adherence to guidelines regarding follow-up management after COPD exacerbation that is :

    • adherence to discharge criteria
    • first medical evaluation one week after discharge
    • early specialized follow-up into four to six weeks after discharge

  7. Frequency of advance directives.

    Time frame: at day 0

    Frequency of advance directives written by patients with COPD

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Official study title

Prevalence, Associated Factors Points and Implementation of Care Procedures of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation in Healthcare Institution. Prospective Cohort Study

Acronym: OPEDEXA

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 12, 2023
Registry last updated
Jan 12, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.