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Outcomes of RV Dysfunction in Acute Exacerbation of Chronic Respiratory Diseases (DVD)

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ClinicalTrials.gov Identifier: NCT04098094
Recruitment Status : Not yet recruiting
First Posted : September 23, 2019
Last Update Posted : September 23, 2019
Sponsor:
Information provided by (Responsible Party):
Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil

Brief 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.

Condition or disease
Acute Exacerbation of COPD Acute Exacerbation of Bronchiectasis Acute Exacerbation of Asthma Interstitial Lung Disease Neuromuscular Diseases Obesity Hypoventilation Syndrome Acute Respiratory Failure

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.

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prevalence of Right Ventricular Dysfunction in Acute Exacerbation of Chronic Respiratory Diseases and Its Impact on Outcomes
Estimated Study Start Date : September 19, 2019
Estimated Primary Completion Date : October 30, 2021
Estimated Study Completion Date : October 30, 2021



Primary Outcome Measures :
  1. Survival [ Time Frame: Day 28 ]
    Survival at day 28


Secondary Outcome Measures :
  1. Duration of ventilation [ Time Frame: Day 28 ]
    Duration of non-invasive ventilation and/or mechanical ventilation


Other Outcome Measures:
  1. Duration of hospital stay [ Time Frame: Day 28 ]
    Duration of hospital stay



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04098094


Contacts
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Contact: Athénaïs Boucly, MD +33669286528 athenais.boucly@gmail.com
Contact: Athénaïs Boucly, MD athenais.boucly@gmail.com

Locations
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France
Service de Pneumologie et Réanimation Médicale, Groupe Hospitalier Pitié Salpêtrière Paris, France
Paris, France, 75013
Sponsors and Collaborators
Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil
Investigators
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Principal Investigator: Alexandre Demoule, MD, PHD Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil
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Responsible Party: Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil
ClinicalTrials.gov Identifier: NCT04098094    
Other Study ID Numbers: 2018-A03192-53
First Posted: September 23, 2019    Key Record Dates
Last Update Posted: September 23, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Diseases
Respiratory Insufficiency
Bronchiectasis
Lung Diseases, Interstitial
Respiration Disorders
Hypoventilation
Obesity Hypoventilation Syndrome
Neuromuscular Diseases
Respiratory Tract Diseases
Bronchial Diseases
Nervous System Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Apnea, Obstructive
Sleep Apnea Syndromes
Apnea
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Obesity
Overnutrition
Nutrition Disorders