DVD: Outcomes of RV Dysfunction in Acute Exacerbation of Chronic Respiratory Diseases

Sponsor
Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil (Other)
Overall Status
Recruiting
CT.gov ID
NCT04098094
Collaborator
(none)
40
1
37.4
1.1

Study Details

Study Description

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.

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 Design

Study Type:
Observational
Anticipated 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
Actual Study Start Date :
Sep 19, 2019
Anticipated Primary Completion Date :
Oct 30, 2022
Anticipated Study Completion Date :
Oct 30, 2022

Outcome Measures

Primary Outcome Measures

  1. Survival [Day 28]

    Survival at day 28

Secondary Outcome Measures

  1. Duration of ventilation [Day 28]

    Duration of non-invasive ventilation and/or mechanical ventilation

Other Outcome Measures

  1. Duration of hospital stay [Day 28]

    Duration of hospital stay

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 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

  • Principal Investigator: Alexandre Demoule, MD, PHD, Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
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:
Sep 23, 2019
Last Update Posted:
Feb 18, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 18, 2022