Acute Exacerbation of COPDDVDNCT04098094
Outcomes of RV Dysfunction in Acute Exacerbation of Chronic Respiratory Diseases
An observational study of Acute Exacerbation of COPD and Acute Exacerbation of Bronchiectasis, run by Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Exacerbation of COPD, Acute Exacerbation of Bronchiectasis, Acute Exacerbation of Asthma
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 19 Sep 2019to 30 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Chronic respiratory disease (COPD, ILD, OHS...)
- Admission in ICU for acute respiratory failure
- Patient's non-opposition
Who cannot join
- Patients < 18 year-old
- Protected patients
- Pregnant women
Trial locations and contacts
1 site in 1 country.
Athénaïs Boucly, MD contact
France1 site, 1 recruiting
- Recruiting
Service de Pneumologie et Réanimation Médicale, Groupe Hospitalier Pitié Salpêtrière Paris, France
Paris, 75013
Alexandre Demoule, MD, PhD, +33142167761, alexandre.demoule@aphp.fr
Athénaïs Boucly, MD, +33669286528, athenais.boucly@gmail.com
About this study
Official title: Prevalence of Right Ventricular Dysfunction in Acute Exacerbation of Chronic Respiratory Diseases and Its Impact on Outcomes
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.
- Conditions
- Acute Exacerbation of COPD, Acute Exacerbation of Bronchiectasis, Acute Exacerbation of Asthma, Interstitial Lung Disease, Neuromuscular Diseases, Obesity Hypoventilation Syndrome
- Medical subject headings
- Lung Diseases, Interstitial, Neuromuscular Diseases, Obesity Hypoventilation Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Survival at day 28
Measured: Day 28
Secondary outcomes (1)
Duration of ventilation
Duration of non-invasive ventilation and/or mechanical ventilation
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2019
- Study start19 Sep 2019
- Primary completion30 Oct 2022 (estimated)
- Study completion30 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Exacerbation of COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexandre Demoule, MD, PHD, Principal investigator, Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04098094
- Sponsor's protocol ID
- 2018-A03192-53
- Acronym
- DVD
- Status last verified
- Feb 2022
- First submitted
- 19 Sep 2019
- Last updated
- 18 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Right Ventricular Dysfunction in Acute Exacerbation of Chronic Respiratory Diseases and Its Impact on Outcomes
- ClinicalTrials.gov ID
- NCT04098094
- Acronym / sponsor ID
- DVD / 2018-A03192-53
- Conditions
- Acute Exacerbation of COPD, Acute Exacerbation of Bronchiectasis, Acute Exacerbation of Asthma, Interstitial Lung Disease, Neuromuscular Diseases, Obesity Hypoventilation Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le SommeilUniversity, hospital or other
- Study start
- 19 Sep 2019 (actual)
- Primary completion
- 30 Oct 2022 (estimated)
- Study completion
- 30 Oct 2022 (estimated)
- First posted
- 23 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Chronic respiratory disease (COPD, ILD, OHS...)
- Admission in ICU for acute respiratory failure
- Patient's non-opposition
Key exclusion criteria (3 listed)
- Patients < 18 year-old
- Protected patients
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Survival
Time frame: Day 28
Survival at day 28
1 secondary outcome
Duration of ventilation
Time frame: Day 28
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2022.
- Individual participant dataSharing planned: No
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COPD Exacerbation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Athénaïs Boucly, MD contact
Alexandre Demoule, MD, PHD principal investigator
Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Exacerbation of COPD and Acute Exacerbation of Bronchiectasis, run by Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Athénaïs Boucly, MD (+33669286528, athenais.boucly@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival (time frame: Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2022.