Patient-Ventilator Dyssynchrony: How is the Effect of Man... | NCT00683072

Studies
Patient-Ventilator Dyssynchrony: How is the Effect of Management?

NCT00683072

Sponsor

National Cheng-Kung University Hospital

Status

Unknown status

Last Update Posted

May 23, 2008Estimated

Enrollment

40Estimated

Phase

Not provided

Conditions

Respiratory Failure

Interventions

Not provided

Countries

Taiwan

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 2008

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

Mar 2008

Primary Completion Date

Dec 2008Estimated

Completion Date

Dec 2008Estimated

First Submitted Date

May 21, 2008

First Submission Date that Met QC Criteria

May 22, 2008

First Posted Date

May 23, 2008Estimated

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

May 22, 2008

Last Update Posted Date

May 23, 2008Estimated

Description Module

Brief Summary

Although patient-ventilator asynchrony is a frequent phenomenon, its course following management is unknown. As the aid of a data recording system, we try to observe the consequence of patient-ventilator asynchrony following management. Our target is aimed at the patients with high asynchronization index ( > 10%) as this group of patients have been shown to have prolonged course in intensive care unit and are also prone to be tracheostomized

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

Not provided

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

40Estimated

Label	Type	Description	Intervention Names
1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Asynchrony index (AI). (Number of asynchrony events/total respiratory rate)		20 minutes after alternation of ventilator settings or any therapeutic means

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients admitted to respiratory intensive care unit with acute respiratory failure and presence of patient-ventilator asynchrony(AI of more than 10%)
patient can trigger the ventilator

Exclusion Criteria:

High oxygen fraction: > 60%.
High PEEP need: > 12cmH2O.
Hemodynamic unstable: shock
Central nervous system problem.
Hyperacitve delirium
Without informed consent

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

Between March 2008 through December 2008, patients admitted to our respiratory intensive care unit for the management of acute respiratory failure were daily screened for the presence of patient-ventilator asynchrony.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Kuang Ming Liao, MD	Contact	886-6-235-3535	2588	abc8870@yahoo.com.tw
Chang Wen Chen, MD, MS	Contact	886-6-235-3535	2577	cwchen@mail.ncku.edu.tw

Overall Officials

Name	Affiliation	Role
Chang wen Chen, MD, MS	National Cheng-Kung University Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Cheng-Kung University Hospital	Recruiting	Tainan		704	Taiwan

Condition Browse Module

MeSH Terms

ID	Term
D012131	Respiratory Insufficiency
D000097742	Patient-Ventilator Asynchrony

Ancestor Terms

ID	Term
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D012818	Signs and Symptoms, Respiratory
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided