The Classification of Difficult Weaning and the Predictiv... | NCT02487927

Studies
The Classification of Difficult Weaning and the Predictive Value of Relative Factors for Difficult Weaning

NCT02487927

Sponsor

Jianfeng Xie

Status

Unknown status

Last Update Posted

Jul 2, 2015Estimated

Enrollment

110Estimated

Phase

Not provided

Conditions

Intensive Care Medicine
Mechanical Ventilation
Weaning

Interventions

weaning

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

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2012

Primary Completion Date

Jul 2015Estimated

Completion Date

Jul 2015Estimated

First Submitted Date

Jun 23, 2015

First Submission Date that Met QC Criteria

Jun 29, 2015

First Posted Date

Jul 2, 2015Estimated

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 29, 2015

Last Update Posted Date

Jul 2, 2015Estimated

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

To evaluate the distribution of different types of difficult weaning and the predictive value of weaning relative factors.

Detailed Description

108 patients who passed the spontaneous breathing test (SBT) were included in this study,every patient were performed 30-60 minutes SBT after enrollment.Patients were divided into succeed weaning and difficult weaning group according the results of SBT, the difficult weaning group were futher divided into A(Airway and Lung dysfunction),B（Brain dysfunction）,C（Cardic dysfunction）,D（Diaphragm dysfunction）,E（Endocrine and metabolic dysfunction）five different groups according to the causes of difficult weaning. The respiratory mechanical parameters,the diameter of inferior vena cava and the diaphgram excursion were recorded before SBT and 30 minutes after SBT.

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

110Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Weaning success		patients pass SBT and weaning without any ventilation in 48 hours	Behavioral: weaning
weaning failure		patients do not pass SBT or ventilation with any ventilation in 48 hours	Behavioral: weaning

Interventions

Name	Type	Description	Arm Group Labels	Other Names
weaning	Behavioral	T piece	Weaning success weaning failure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the reasons of difficult weaning		30 mins

Secondary Outcomes

Measure	Description	Time Frame
The predictive value of diaphragm associated values in weaning		30mins

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

mechanical ventilation patients
prepared to weaning
sign on the acknowledged

Exclusion Criteria:

endotracheotomy
single lung
pregnant
heart,liver,renal failure

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

80 Years

Standard Ages

ChildAdultOlder Adult

Study Population

mechanical vetilation patients in ICU, and the patients are weaninng candidates

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jianfeng Xie, Dr	Contact	+862583262550		panchun1982@gmail.com

Overall Officials

Name	Affiliation	Role
Haibo Qiu, Dr	Southeast University	Study Director

Locations

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

Intervention Browse Module

MeSH Terms

ID	Term
D014886	Weaning

Ancestor Terms

ID	Term
D007227	Infant Nutritional Physiological Phenomena
D002664	Child Nutritional Physiological Phenomena
D009747	Nutritional Physiological Phenomena
D000066888	Diet, Food, and Nutrition

Browse Leaves

Not provided

Browse Branches

Not provided