ClinicalTrials.gg
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has not verified this record recently (last verified Feb 2022), so the status shown — last known as Recruiting — may be out of date.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

Where this study stands

Counted across the records on this site · 2026-11-12

Among 90 studies in Lung Diseases, Interstitial with a site in France — 37 open to participants now, 48 under way, 15 of them phase 3. Lung Diseases, Interstitial · France.

Planned enrollment
27th of 30
40 · median 265
Started
2019
with 4 others
Observational
30 of 90
10 open now
Registered
23rd of 90
by date

Among the 90 studies in Lung Diseases, Interstitial with a site in France, this one is the 27th largest by planned enrollment of the 30 observational ones, is one of 5 that started in 2019, is one of 30 observational ones, and was the 23rd registered.

By phase

90 studies; the count open now beside each. This study's row is marked.

Observationalthis study30 · 10 open
Phase 327 · 11 open
No phase18 · 9 open
Phase 211 · 4 open
Phase 2/32 · 1 open
Phase 11 · 1 open
Phase 1/21 · 1 open

By the year they started

First in 2003; this study’s year is marked. 5 started in 2019.

Size and results

Median enrollment 138 across the 60 interventional studies, 265 across the 30 observational. Of the 34 that completed or were terminated, 12 (35%) have results posted.

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02

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.
03

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
04

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Chronic respiratory disease (, 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
40 participants (estimated)
Patient registry
No
06

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

07

Study locations

1 of 1 sites recruiting
  • Service de Pneumologie et Réanimation Médicale, Groupe Hospitalier Pitié Salpêtrière Paris, France
    Paris, 75013, France
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2019 (actual). Primary completion is estimated for Oct 2022, 37 months after the start.

Of 111 non-industry observational studies under Lung Diseases, Interstitial, half reached primary completion within 72 months of starting (the median), counting those still running; a quarter within 35 and three quarters within 274. This study's planned 37 months is below that.

Counting every sponsor, half of 132 studies reached it within 55 months; a quarter within 31 and three quarters within 83.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 19, 2019
First posted
Sep 23, 2019
StartActual
Sep 19, 2019
Primary completionEst.
Oct 30, 2022
CompletionEst.
Oct 30, 2022
Last update
Feb 18, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 18, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

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 ↗

Not currently enrolling

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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Discussion

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