Outcomes of RV Dysfunction in Acute Exacerbation of Chron... | NCT04098094

Studies
Outcomes of RV Dysfunction in Acute Exacerbation of Chronic Respiratory Diseases

NCT04098094

Sponsor

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

Status

Unknown status

Last Update Posted

Feb 18, 2022Actual

Enrollment

40Estimated

Phase

Not provided

Conditions

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

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Feb 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 19, 2019Actual

Primary Completion Date

Oct 30, 2022Estimated

Completion Date

Oct 30, 2022Estimated

First Submitted Date

Sep 19, 2019

First Submission Date that Met QC Criteria

Sep 19, 2019

First Posted Date

Sep 23, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 17, 2022

Last Update Posted Date

Feb 18, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sponsor

Lead Sponsor

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

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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.

Conditions Module

Conditions

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

Keywords

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Survival	Survival at day 28	Day 28

Secondary Outcomes

Measure	Description	Time Frame
Duration of ventilation	Duration of non-invasive ventilation and/or mechanical ventilation	Day 28

Other Outcomes

Measure	Description	Time Frame
Duration of hospital stay	Duration of hospital stay	Day 28

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Athénaïs Boucly, MD	Contact	+33669286528		athenais.boucly@gmail.com
Athénaïs Boucly, MD	Contact			athenais.boucly@gmail.com

Overall Officials

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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Service de Pneumologie et Réanimation Médicale, Groupe Hospitalier Pitié Salpêtrière Paris, France	Recruiting	Paris		75013	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D017563	Lung Diseases, Interstitial
D009468	Neuromuscular Diseases
D010845	Obesity Hypoventilation Syndrome

Ancestor Terms

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D009422	Nervous System Diseases
D020181	Sleep Apnea, Obstructive
D012891	Sleep Apnea Syndromes
D001049	Apnea
D012120	Respiration Disorders
D007040	Hypoventilation
D012131	Respiratory Insufficiency
D020919	Sleep Disorders, Intrinsic
D020920	Dyssomnias
D012893	Sleep Wake Disorders
D009765	Obesity
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases