Interstitial Lung DiseaseNCT03416075

Mechanical Ventilation in Interstitial Lung Disease

An observational study of Interstitial Lung Disease and Mechanical Ventilation, run by Beijing Chao Yang Hospital.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

To identify risk factors for mortality in patients with interstitial lung disease receiving mechanical ventilation. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Interstitial Lung Disease, Mechanical Ventilation, Risk Factors
What is being tested?: Mechanical ventilation
Type of treatment: Medical device
How many people: 94 participants
Where: No sites listed yet
Study dates: 1 Jan 2011to 31 Dec 2017
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: Patients were diagnosed as interstitial lung disease and received mechanical ventilation.

Who may be able to join

They were clearly diagnosed as interstitial lung disease in hospital;
They had progressive worsening of dyspnea and their oxygenation indexes were less than 300 in ICU;
They received at least 48 hours of mechanical ventilation after being admitted into ICU.

Who cannot join

We excluded patients who were admitted into ICU because of postoperative monitoring.

About this study

Official title: Risk Factors for Mortality in Patients With Interstitial Lung Disease Receiving Mechanical Ventilation: A Retrospective, Observational Cohort Study

To identify risk factors for mortality in patients with interstitial lung disease receiving mechanical ventilation.

Conditions: Interstitial Lung Disease, Mechanical Ventilation, Risk Factors, Morality
Being tested: Mechanical ventilation
Medical subject headings: Lung Diseases, Interstitial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Mechanical ventilationDevice
Noninvasive and/or invasive mechanical ventilation were performed when patients had respiratory failure.

What is being measured

The primary outcome is the main question the study is designed to answer.

ICU Mortality
Measured: 7 years

Secondary outcomes (3)

Hospital mortality
Measured: 7 years
Noninvasive mechanical ventilation failure
Measured: 7 years
Invasive mechanical ventilation failure
Measured: 7 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 201131 Dec 2017

First posted30 Jan 2018
Study start1 Jan 2011
Primary completion31 Dec 2017
Study completion31 Dec 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Interstitial Lung DiseaseStudies 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: Retrospective
Enrolment: 94 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03416075
Sponsor's protocol ID: BeijingCYH-ICU-006
Status last verified: Jan 2018
First submitted: 7 Jan 2018
Last updated: 30 Jan 2018
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingPhase 3
A Study to Find Out How Nerandomilast is Tolerated, Handled by the Body, and if it Helps Children and Adolescents With Interstitial Lung Disease (FIBRONEER-chILD)
Fibrosing Interstitial Lung Disease
Active, not recruitingPhase 2
A Study to Find Out Whether BI 765423 Has an Effect on Lung Function in People With Idiopathic Pulmonary Fibrosis (IPF) With or Without Standard Treatment
Idiopathic Pulmonary Fibrosis
RecruitingPhase 2
Study of TX000045 in Participants With Pulmonary Hypertension Due to Interstitial Lung Disease
Hypertension, Pulmonary, Lung Diseases, Interstitial
RecruitingPhase 2
Study to Evaluate the Efficacy, Safety, and Tolerability of PIPE 791 in Subjects With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
RecruitingPhase 3
An Open-Label Extension Study of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)
Pulmonary Hypertension, Interstitial Lung Disease

All Interstitial Lung Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Risk Factors for Mortality in Patients With Interstitial Lung Disease Receiving Mechanical Ventilation: A Retrospective, Observational Cohort Study
ClinicalTrials.gov ID: NCT03416075
Acronym / sponsor ID: BeijingCYH-ICU-006
Conditions: Interstitial Lung Disease, Mechanical Ventilation, Risk Factors, Morality
Study type: Observational
Recruitment status: Completed
Enrolment: 94 participants (actual)
Lead sponsor: Beijing Chao Yang HospitalUniversity, hospital or other
Study start: 1 Jan 2011 (actual)
Primary completion: 31 Dec 2017 (actual)
Study completion: 31 Dec 2017 (actual)
First posted: 30 Jan 2018 (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.

To identify risk factors for mortality in patients with interstitial lung disease receiving mechanical ventilation.

Study design

Observational model: Cohort
Time perspective: Retrospective

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients were diagnosed as interstitial lung disease and received mechanical ventilation.

Key inclusion criteria (3 listed)

They were clearly diagnosed as interstitial lung disease in hospital;
They had progressive worsening of dyspnea and their oxygenation indexes were less than 300 in ICU;
They received at least 48 hours of mechanical ventilation after being admitted into ICU.

Key exclusion criteria (1 listed)

We excluded patients who were admitted into ICU because of postoperative monitoring.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Mechanical ventilationNoninvasive and/or invasive mechanical ventilation were performed when patients had respiratory failure.	Device	–

Primary outcome

ICU Mortality
Time frame: 7 years

3 secondary outcomes

Hospital mortality
Time frame: 7 years
Noninvasive mechanical ventilation failure
Time frame: 7 years
Invasive mechanical ventilation failure
Time frame: 7 years

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2018.
Individual participant dataSharing planned: No

Related trials for Interstitial Lung Disease

RecruitingPhase 3
A Study to Find Out How Nerandomilast is Tolerated, Handled by the Body, and if it Helps Children and Adolescents With Interstitial Lung Disease (FIBRONEER-chILD)
Fibrosing Interstitial Lung Disease
Active, not recruitingPhase 2
A Study to Find Out Whether BI 765423 Has an Effect on Lung Function in People With Idiopathic Pulmonary Fibrosis (IPF) With or Without Standard Treatment
Idiopathic Pulmonary Fibrosis
RecruitingPhase 2
Study of TX000045 in Participants With Pulmonary Hypertension Due to Interstitial Lung Disease
Hypertension, Pulmonary, Lung Diseases, Interstitial
RecruitingPhase 2
Study to Evaluate the Efficacy, Safety, and Tolerability of PIPE 791 in Subjects With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
RecruitingPhase 3
An Open-Label Extension Study of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)
Pulmonary Hypertension, Interstitial Lung Disease

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.

Zujin Luo, MD principal investigator

Beijing Chao Yang Hospital

Questions about this trial

What is this clinical trial studying?

An observational study of Interstitial Lung Disease and Mechanical Ventilation, run by Beijing Chao Yang Hospital.

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 1 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: finished, as of the sponsor's last update on 30 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ICU Mortality (time frame: 7 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03416075.

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 30 Jan 2018.