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Status unknownNCT04098094DVDUpdated Feb 18, 2022

Outcomes of RV Dysfunction in Acute Exacerbation of Chronic Respiratory Diseases

An observational study in Acute Exacerbation of COPD, Acute Exacerbation of Bronchiectasis and Acute Exacerbation of Asthma, sponsored by Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-02-18.

Sponsored by Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil · Observational

The sponsor has not verified this record recently (last verified Feb 2022), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
40
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Acute Exacerbation of COPD
  • Acute Exacerbation of Bronchiectasis
  • Acute Exacerbation of Asthma
  • Interstitial Lung Disease
  • Neuromuscular Diseases
  • Obesity Hypoventilation Syndrome
  • Acute Respiratory Failure
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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.

Inclusion criteria

  • Chronic respiratory disease (COPD, ILD, OHS...)
  • Admission in ICU for acute respiratory failure
  • Patient's non-opposition

Exclusion criteria

Exclusion Criteria:

  • Patients \< 18 year-old
  • Protected patients
  • Pregnant women
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
40 participants (estimated)
Patient registry
No
05

What researchers measure

Primary outcomes

  1. Survival

    Survival at day 28

    Time frame: Day 28

Secondary outcomes

  1. Duration of ventilation

    Duration of non-invasive ventilation and/or mechanical ventilation

    Time frame: Day 28

Other outcomes

  1. Duration of hospital stay

    Duration of hospital stay

    Time frame: Day 28

06

Study locations

1 of 1 sites recruiting
  • Service de Pneumologie et Réanimation Médicale, Groupe Hospitalier Pitié Salpêtrière Paris, France
    Paris, 75013, France
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT04098094
Lead sponsor
Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil
Responsible party
Sponsor
First posted
Sep 23, 2019
Start date
Sep 19, 2019
Primary completion
Oct 30, 2022 (estimated)
Completion
Oct 30, 2022 (estimated)
Last update
Feb 18, 2022

Study contacts

Athénaïs Boucly, MD
Contact
athenais.boucly@gmail.com
+33669286528
Athénaïs Boucly, MD
Contact
athenais.boucly@gmail.com
Alexandre Demoule, MD, PHD
principal investigator · Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

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