NCT04098094

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 19, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

September 19, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 23, 2019

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2022

Completed
Last Updated

February 18, 2022

Status Verified

February 1, 2022

Enrollment Period

3.1 years

First QC Date

September 19, 2019

Last Update Submit

February 17, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Survival

    Survival at day 28

    Day 28

Secondary Outcomes (1)

  • Duration of ventilation

    Day 28

Other Outcomes (1)

  • Duration of hospital stay

    Day 28

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Pneumologie et Réanimation Médicale, Groupe Hospitalier Pitié Salpêtrière Paris, France

Paris, 75013, France

RECRUITING

MeSH Terms

Conditions

Lung Diseases, InterstitialNeuromuscular DiseasesObesity Hypoventilation Syndrome

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesNervous System DiseasesSleep Apnea, ObstructiveSleep Apnea SyndromesApneaRespiration DisordersHypoventilationRespiratory InsufficiencySleep Disorders, IntrinsicDyssomniasSleep Wake DisordersObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Alexandre Demoule, MD, PHD

    Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Athénaïs Boucly, MD

CONTACT

Athénaïs Boucly, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 19, 2019

First Posted

September 23, 2019

Study Start

September 19, 2019

Primary Completion

October 30, 2022

Study Completion

October 30, 2022

Last Updated

February 18, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations