COPD ExacerbationOPEDEXANCT05682404
Prevalence, Associated Factors Points and Implementation of Care Procedures of Chronic Obstructive Pulmonary Disease Exacerbation in Healthcare Institution
An observational study of COPD Exacerbation, run by University Hospital, Grenoble at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD Exacerbation
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2017to 30 Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- opposition to participate at the study
- Patients under the law
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- COPD Exacerbation
- Keywords
- COPD, exacerbation, Prospective, Observational, Professional practices guidelines
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 30 days
Secondary outcomes (7)
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
Measured: up to 30 days
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
Measured: up to 30 days
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
Measured: up to 30 days
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
Measured: up to 30 days
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.
Measured: up to 30 days
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
Measured: up to 30 days
Frequency of advance directives.
Frequency of advance directives written by patients with COPD
Measured: at day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2023
- Study start1 Oct 2017
- Primary completion30 Mar 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD ExacerbationStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05682404
- Sponsor's protocol ID
- OPEDEXA (38RC17.073)
- Acronym
- OPEDEXA
- Status last verified
- Jan 2023
- First submitted
- 16 Apr 2019
- Last updated
- 12 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence, Associated Factors Points and Implementation of Care Procedures of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation in Healthcare Institution. Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT05682404
- Acronym / sponsor ID
- OPEDEXA / OPEDEXA (38RC17.073)
- Conditions
- COPD Exacerbation
- Keywords
- COPD, exacerbation, Prospective, Observational, Professional practices guidelines
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 30 Mar 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 12 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- opposition to participate at the study
- Patients under the law
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
7 secondary outcomes
Percentage of corticosteroids prescriptions following the guidelines in COPD exacerbation.
Time frame: up to 30 days
Percentage of hospitalization of patients following the guidelines in COPD exacerbation.
Time frame: up to 30 days
Percentage of non invasive ventilation following the guidelines in COPD exacerbation.
Time frame: up to 30 days
Percentage of invasive ventilation following the guidelines in COPD
Time frame: up to 30 days
Percentage of minimal medical examinations following the guidelines in COPD exacerbation.
Time frame: up to 30 days
Percentage of follow-up management after COPD exacerbation following the guidelines
Time frame: up to 30 days
Frequency of advance directives.
Time frame: at day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2023.
Related trials for COPD Exacerbation
Active, not recruiting
Influence of FreeO2 on Percentage of Time Within Oxygen Saturation Target Using Noninvasive Ventilation (NIV) and Continuous Positive Airway Pressure (CPAP) for Patients Admitted for AECOPD or Bariatric Surgery
COPD Exacerbation, Oxygen Toxicity
Active, not recruiting
FreeDom: Innovative Strategy for the Management of COPD Exacerbations
Oxygen Deficiency, COPD Exacerbation
RecruitingPhase 2
Rademikibart IV for Acute Asthma and COPD Exacerbation
Asthma Acute, COPD Exacerbation Acute
Not yet recruitingPhase 1
Investigating Senolytic Properties in Pulmonary Rehabilitation and Metformin in COPD Exacerbations
Chronic Obstructive Pulmonary Disease (COPD)
RecruitingObservational study
Swiss Chronic Obstructive Pulmonary Disease (COPD) Management Cohort
Chronic Obstructive Pulmonary Disease, COPD Exacerbation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD Exacerbation, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of antibiotics prescriptions following the guidelines in COPD exacerbation. (time frame: up to 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2023.