- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04098094
Outcomes of RV Dysfunction in Acute Exacerbation of Chronic Respiratory Diseases (DVD)
February 17, 2022 updated by: Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil
Prevalence of Right Ventricular Dysfunction in Acute Exacerbation of Chronic Respiratory Diseases and Its Impact on Outcomes
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.
Study Overview
Status
Recruiting
Detailed 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.
Study Type
Observational
Enrollment (Anticipated)
40
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Athénaïs Boucly, MD
- Phone Number: +33669286528
- Email: athenais.boucly@gmail.com
Study Contact Backup
- Name: Athénaïs Boucly, MD
- Email: athenais.boucly@gmail.com
Study Locations
-
-
-
Paris, France, 75013
- Recruiting
- Service de Pneumologie et Réanimation Médicale, Groupe Hospitalier Pitié Salpêtrière Paris, France
-
Contact:
- Athénaïs Boucly, MD
- Phone Number: +33669286528
- Email: athenais.boucly@gmail.com
-
Contact:
- Alexandre Demoule, MD, PhD
- Phone Number: +33142167761
- Email: alexandre.demoule@aphp.fr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
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.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Survival
Time Frame: Day 28
|
Survival at day 28
|
Day 28
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Duration of ventilation
Time Frame: Day 28
|
Duration of non-invasive ventilation and/or mechanical ventilation
|
Day 28
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Duration of hospital stay
Time Frame: Day 28
|
Duration of hospital stay
|
Day 28
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Alexandre Demoule, MD, PHD, Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
September 19, 2019
Primary Completion (ANTICIPATED)
October 30, 2022
Study Completion (ANTICIPATED)
October 30, 2022
Study Registration Dates
First Submitted
September 19, 2019
First Submitted That Met QC Criteria
September 19, 2019
First Posted (ACTUAL)
September 23, 2019
Study Record Updates
Last Update Posted (ACTUAL)
February 18, 2022
Last Update Submitted That Met QC Criteria
February 17, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Apnea
- Sleep Disorders, Intrinsic
- Dyssomnias
- Sleep Wake Disorders
- Bronchial Diseases
- Overnutrition
- Nutrition Disorders
- Signs and Symptoms, Respiratory
- Sleep Apnea Syndromes
- Obesity
- Sleep Apnea, Obstructive
- Bronchiectasis
- Lung Diseases
- Respiratory Insufficiency
- Lung Diseases, Interstitial
- Respiration Disorders
- Respiratory Tract Diseases
- Hypoventilation
- Obesity Hypoventilation Syndrome
- Neuromuscular Diseases
Other Study ID Numbers
- 2018-A03192-53
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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