Patients With Severe Acute Exacerbation of COPD Ans Admitted in ICU Register.
NCT ID: NCT06257329
Last Updated: 2024-02-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
2000 participants
OBSERVATIONAL
2022-10-01
2028-04-01
Brief Summary
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Detailed Description
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This research is conducted in accordance with the reference methodology MR 004 approved by the National Commission of Informatics and Libertés (CNIL) and to which the Centre hospitalier de Versailles is committed to comply. For this purpose, an information note will be given to each patient participating in this project in order to seek its non-opposition of participation in this study.
This prospective study is based solely on the examination of files medical. The data collected are only non-sensitive medical data.
This study complies with legal and regulatory requirements. In addition, this research project was submitted to the Ethics Committee (EC) of the Société de Réanimation de Langue Française (SRLF) who gave an opinion favorable on 06/10/2022 (Registration number referenced: CE SRLF 22- 056).
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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register
Multicentre prospective observational register
Eligibility Criteria
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Inclusion Criteria
2. COPD documented or strongly suspected
* Chronic respiratory symptoms (dyspnoea, cough and/or sputum)
* Exposure to a known risk factor for COPD (such as tobacco smoke)
* If available, respiratory function tests showing non- or partially reversible obstructive syndrom (post-bronchodilator ratio FEV1/CV \< 0.7)
3. Severe acute exacerbation, defined as a worsening of the patient's usual respiratory symptoms with signs of acute respiratory distress (polypnoea ≥ 30 cycles.min-1 or use of accessory respiratory muscles) and/or hypercapnic acidosis (with PaCO2 ≥ 45 mmHg and pH ≤ 7.35)
4. Admission to an ICU, a step-up unit or a respiratory care unit
Exclusion Criteria
2. Patient refusal to participate (information note, application for non-opposition)
40 Years
ALL
No
Sponsors
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Alexis FERRE
OTHER
Responsible Party
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Alexis FERRE
coordinating investigator
Locations
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Centre hospitalier de Versailles
Le Chesnay, , France
CH Le Mans
Le Mans, , France
Countries
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Central Contacts
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Facility Contacts
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alexis Ferre
Role: primary
Jean Christophe CALLAHAN
Role: primary
Other Identifiers
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P22/13_BPCO register
Identifier Type: -
Identifier Source: org_study_id
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