the Influence of Tidal Volume to Lung Strain | NCT01864668

Studies
the Influence of Tidal Volume to Lung Strain

NCT01864668

Sponsor

Zhongda Hospital

Status

Unknown status

Last Update Posted

Feb 11, 2014Estimated

Enrollment

25Estimated

Phase

Not provided

Conditions

Critically Ill
Acute Respiratory Distress Syndrome

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

May 2013

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

Jun 2013

Primary Completion Date

Mar 2014Estimated

Completion Date

Mar 2014Estimated

First Submitted Date

May 21, 2013

First Submission Date that Met QC Criteria

May 28, 2013

First Posted Date

May 29, 2013Estimated

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 8, 2014

Last Update Posted Date

Feb 11, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

Measure the lung strain in different tidal volume in ADRS patients to find the relationship between tidal volume and lung strain and find the most suitable tidal volume for each patient.

Detailed Description

Purpose:Find the relationship between tidal volume and lung strain in ARDS patients.Then find the most suitable tidal volume for each patient according to the dividing value.

Methods:Measure the lung strain in the tidal volume of 6mL/kg,8mL/kg,10mL/kg and 12mL/kg in each ARDS patient.

Hypothesis:With the increase of the tidal volume,the lung strain develops.In the patient with larger lung compliance,the strain of the group of conventional tidal volume is less than 0.27 and there is no obvious difference between the group of small tidal volume.

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

25Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the strain in different tidal volume	Use the GE ventilator to measure the EELV and calculate the lung strain(lung strain = VT/EELV)	2 hours

Secondary Outcomes

Measure	Description	Time Frame
28 days mortality	Follow up to determine the mortality in 28 days after inclusion	28 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age:18-85,gender is not limited
Needing Invasive ventilation
Fit the definition of ARDS in 2012 "Berlin Definition"
Sign the paper of informed consent

Exclusion Criteria:

pregnancy and at the end stage of tumour
the COPD patients
less than 24h of mechanical ventilation
more than 5 days of mechanical ventilation
FiO2>80%
presence of air leaks
organ dysfunction and hemodynamic instability
including in other research

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

Critical patients diagnosed with acute respiratory distress syndrome

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Xiaohua Qiu, MD	Contact	0086-025-83262553		xiaohua0917@163.com
Fang Jin, MD	Contact	0086-15850601638		doris_king@163.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Affiliated Zhongda Hospital of Southeast University	Recruiting	Nanjing	Jiangsu	210009	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28159013	Derived	Xie J, Jin F, Pan C, Liu S, Liu L, Xu J, Yang Y, Qiu H. The effects of low tidal ventilation on lung strain correlate with respiratory system compliance. Crit Care. 2017 Feb 3;21(1):23. doi: 10.1186/s13054-017-1600-x.

ID	Term
D016638	Critical Illness
D012128	Respiratory Distress Syndrome

ID	Term
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D008171	Lung Diseases