Mechanical Ventilation in Interstitial Lung Disease | NCT03416075

Studies
Mechanical Ventilation in Interstitial Lung Disease

NCT03416075

Sponsor

Beijing Chao Yang Hospital

Status

Completed

Last Update Posted

Jan 30, 2018Actual

Enrollment

94Actual

Phase

Not provided

Conditions

Interstitial Lung Disease
Mechanical Ventilation
Risk Factors
Morality

Interventions

Mechanical ventilation

Countries

Not provided

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

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2011Actual

Primary Completion Date

Dec 31, 2017Actual

Completion Date

Dec 31, 2017Actual

First Submitted Date

Jan 7, 2018

First Submission Date that Met QC Criteria

Jan 29, 2018

First Posted Date

Jan 30, 2018Actual

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

Jan 29, 2018

Last Update Posted Date

Jan 30, 2018Actual

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

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

Detailed Description

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

94Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mechanical ventilation	Device	Noninvasive and/or invasive mechanical ventilation were performed when patients had respiratory failure.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
ICU Mortality		7 years

Secondary Outcomes

Measure	Description	Time Frame
Hospital mortality		7 years
Noninvasive mechanical ventilation failure		7 years
Invasive mechanical ventilation failure

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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

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

Patients were diagnosed as interstitial lung disease and received mechanical ventilation.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Zujin Luo, MD	Beijing Chao Yang Hospital	Principal Investigator

Locations

Not provided

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

Condition Browse Module

MeSH Terms

ID	Term
D017563	Lung Diseases, Interstitial

Ancestor Terms

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D012121	Respiration, Artificial

Ancestor Terms

ID	Term
D058109	Airway Management
D013812	Therapeutics
D012151	Resuscitation
D004638	Emergency Treatment

Browse Leaves

Not provided

Browse Branches

Not provided