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

COPD Exacerbation Clinical Trial

— OPEDEXA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05682404
• Other study ID #: OPEDEXA (38RC17.073)
• Status: Completed
• Start date: October 1, 2017
• Est. completion date: June 30, 2018

Study information

• Verified date: January 2023
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 30, 2018
• Est. primary completion date: March 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COPD Exacerbation
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
France	CHU Grenoble Alpes	Grenoble

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of antibiotics prescriptions following the guidelines in COPD exacerbation.	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	Percentage of corticosteroids prescriptions following the guidelines in COPD exacerbation.	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
Secondary	Percentage of hospitalization of patients following the guidelines in COPD exacerbation.	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
Secondary	Percentage of non invasive ventilation following the guidelines in COPD exacerbation.	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
Secondary	Percentage of invasive ventilation following the guidelines in COPD	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
Secondary	Percentage of minimal medical examinations following the guidelines in COPD exacerbation.	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
Secondary	Percentage of follow-up management after COPD exacerbation following the guidelines	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
Secondary	Frequency of advance directives.	Frequency of advance directives written by patients with COPD	at day 0