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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04098094
Other study ID # 2018-A03192-53
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 19, 2019
Est. completion date October 30, 2022

Study information

Verified date February 2022
Source Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil
Contact Athénaïs Boucly, MD
Phone +33669286528
Email athenais.boucly@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Observational study in patients with chronic respiratory diseases (chronic obstructive pulmonary diseases, bronchiectasis, interstitial lung diseases, neuromuscular diseases, obesity-hypoventilation syndrome...) admitted in intensive care unit for acute respiratory failure. The main objective is to determine the prevalence of right ventricular (RV) dysfunction in this population and to analyze the impact of such a complication on outcomes (survival at day-28, duration of non-invasive or mechanical ventilation, duration of hospital stay). RV function will be assessed by echocardiography at admission, after 3 days and at discharge. Plasma NT-proBNP and troponin levels will be collected.


Description:

Observational study in patients with chronic respiratory diseases (chronic obstructive pulmonary diseases, bronchiectasis, interstitial lung diseases, neuromuscular diseases, obesity-hypoventilation syndrome...) admitted in intensive care unit for acute respiratory failure. Inclusion Criteria: - Chronic respiratory disease (COPD, ILD, OHS...) - Admission in ICU for acute respiratory failure - Patient's non-opposition Exclusion Criteria: - Patients < 18 year-old - Protected patients - Pregnant women The main objective is to determine the prevalence of right ventricular (RV) dysfunction in this population and to analyze the impact of such a complication on outcomes (survival at day-28, duration of non-invasive or mechanical ventilation, duration of hospital stay). RV function will be assessed by echocardiography at admission, after 3 days and at discharge. Plasma NT-proBNP and troponin levels will be collected.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date October 30, 2022
Est. primary completion date October 30, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Chronic respiratory disease (COPD, ILD, OHS...) - Admission in ICU for acute respiratory failure - Patient's non-opposition Exclusion Criteria: - Patients < 18 year-old - Protected patients - Pregnant women

Study Design


Locations

Country Name City State
France Service de Pneumologie et Réanimation Médicale, Groupe Hospitalier Pitié Salpêtrière Paris, France Paris

Sponsors (1)

Lead Sponsor Collaborator
Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Other Duration of hospital stay Duration of hospital stay Day 28
Primary Survival Survival at day 28 Day 28
Secondary Duration of ventilation Duration of non-invasive ventilation and/or mechanical ventilation Day 28
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