Patients With Severe Acute Exacerbation of COPD Ans Admitted in ICU Register.

NCT ID: NCT06257329

Last Updated: 2024-02-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-01

Study Completion Date

2028-04-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The objective of this prospective observational study is to describe the epidemiological, clinical and biological characteristics of admitted patients in ICU for severe acute exacerbation of COPD, to assess the different therapeutics used, to evaluate the prognosis of patients with short, medium and long term ( 1 year) and the various factors associated with survival in ICU

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is a prospective study for which data will be collected from pseudonymised. General information on the research activity clinic of the Intensive Care Service of the CH of Versailles is provided by poster, patient booklet or debrief hospitalization, indicating to relatives and/ or patients their possible participation in retrospective or prospective studies.

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

See the medical conditions and disease areas that this research is targeting or investigating.

COPD Exacerbation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

register

Multicentre prospective observational register

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Age ≥ 40 years old
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

1. Known asthma (according to the criteria of the international "Global initiative for asthma" guidelines)
2. Patient refusal to participate (information note, application for non-opposition)
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Alexis FERRE

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Alexis FERRE

coordinating investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Centre hospitalier de Versailles

Le Chesnay, , France

Site Status RECRUITING

CH Le Mans

Le Mans, , France

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

alexis ferre

Role: CONTACT

+33.1.39.63.88.37

virginie chatagner

Role: CONTACT

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

alexis Ferre

Role: primary

Jean Christophe CALLAHAN

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

P22/13_BPCO register

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.