Effects of Chest Wall Elastance on Pulmonary Mechanics of... | NCT02196870

Studies
Effects of Chest Wall Elastance on Pulmonary Mechanics of Acute Respiratory Failure (ARF)

NCT02196870

Sponsor

Southeast University, China

Status

Completed

Last Update Posted

Jun 24, 2015Estimated

Enrollment

12Actual

Phase

Not provided

Conditions

Airway Pressure Stress Index
Transpulmonary Pressure Stress Index
Acute Respiratory Failure
Chest Wall Elastance

Interventions

Not provided

Countries

China

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

Jun 2015

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

Jul 2014

Primary Completion Date

Jun 2015Actual

Completion Date

Jun 2015Actual

First Submitted Date

Jul 12, 2014

First Submission Date that Met QC Criteria

Jul 21, 2014

First Posted Date

Jul 22, 2014Estimated

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

Jun 23, 2015

Last Update Posted Date

Jun 24, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jianfeng Xie, Department of Critical Care Medicine, Zhong-Da Hospital, Southeast University, ChinaPrincipal Investigator

Lead Sponsor

Southeast University, ChinaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

Patients with chest wall elastance increasing could worsen lung function. Increasing of chest wall elastance plays a great role in lung mechanics, and could influence mechanical ventilation settings. Therefore, It could help the physicians to find appropriate indicators and optimize the treatments of ARF patients to explore the mechanisms of lung mechanics changse in the patients with high chest wall elastance.

Detailed Description

Mechanical ventilation(MV) is an important treatment for acute respiratory failure(ARF) patients, could improve hypoxemia, maintain lung volume and promote alveolar opening. However, because of barotrauma, volutrauma and biotrauma, MV could cause or aggravate acute lung injury not only in acute respiratory distress syndrome(ARDS) patients, but in patients with normal lung function1,2.

The present study is set out to examine the effects of high chest wall elastance on changes of lung mechanics and the correlation of airway pressure(Paw) stress index and transpulmonary pressure(PL) stress index.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

3 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Measure	Description	Time Frame
Changes of oxygenation and lung mechanics		up to 24 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ARF
mechanical ventilation
cardiovascular stable

Exclusion Criteria:

age < 18y or > 85y
pregnancy
COPD or chronic pulmonary disease

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

acute respiratory failure patients

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jianfeng Xie, Dr.	Zhongda hospital, Southeast University, Jiangsu, China	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Zhongda Hospital		Nanjing	Jiangsu	210009	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27411451	Derived	Pan C, Chen L, Zhang YH, Liu W, Urbino R, Ranieri VM, Qiu HB, Yang Y. Physiological Correlation of Airway Pressure and Transpulmonary Pressure Stress Index on Respiratory Mechanics in Acute Respiratory Failure. Chin Med J (Engl). 2016 Jul 20;129(14):1652-7. doi: 10.4103/0366-6999.185855.