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

COPD Exacerbation Clinical Trial

— COPDregister  

Official title:

Epidemiological, Clinical and Biological Characteristics and Therapeutic Management of ICU Patients With Severe Acute Exacerbation of COPD. Evaluation of Prognosis and Factors Associated With Survival.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06257329
• Other study ID #: P22/13_BPCO register
• Status: Recruiting
• Start date: October 1, 2022
• Est. completion date: April 1, 2028

Study information

• Verified date: February 2024
• Source: Versailles Hospital
• Contact: alexis ferre
• Phone: +33.1.39.63.88.37
• Email: aferre[@]ght78sud.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

Description:

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: April 1, 2028
• Est. primary completion date: October 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• COPD Exacerbation

Intervention

Other:
• register
Multicentre prospective observational register

Locations

Country	Name	City	State
France	Centre hospitalier de Versailles	Le Chesnay
France	CH Le Mans	Le Mans

Sponsors (1)

Lead Sponsor	Collaborator
Alexis FERRE

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the epidemiological, clinical and biological characteristics of patients admitted to the ICU for a severe acute exacerbation of COPD	to describe the epidemiological, clinical and biological characteristics of patients admitted to the ICU for a severe acute exacerbation of COPD	5 year