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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05682404
Other study ID # OPEDEXA (38RC17.073)
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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