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

January 10, 2023 updated by: University Hospital, Grenoble

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Grenoble, France
        • Chu Grenoble Alpes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Every Patient who is 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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to 30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to 30 days
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
up to 30 days
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
up to 30 days
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
up to 30 days
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.
up to 30 days
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
up to 30 days
Frequency of advance directives.
Time Frame: at day 0
Frequency of advance directives written by patients with COPD
at day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2017

Primary Completion (Actual)

March 30, 2018

Study Completion (Actual)

June 30, 2018

Study Registration Dates

First Submitted

April 16, 2019

First Submitted That Met QC Criteria

January 10, 2023

First Posted (Actual)

January 12, 2023

Study Record Updates

Last Update Posted (Actual)

January 12, 2023

Last Update Submitted That Met QC Criteria

January 10, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OPEDEXA (38RC17.073)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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