Intubation and Extubation Over 48 Hours Mechanical Ventil... | NCT01123681

Studies
Intubation and Extubation Over 48 Hours Mechanical Ventilation

NCT01123681

Sponsor

Okayama Research Investigator Organizing Network

Status

Unknown status

Last Update Posted

Nov 16, 2010Estimated

Enrollment

200Estimated

Phase

Not provided

Conditions

Pneumonia, Ventilator-Associated
Critical Illness

Interventions

Choice of endotracheal tube

Countries

Japan

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

Nov 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2010

Primary Completion Date

Dec 2010Estimated

Completion Date

Not provided

First Submitted Date

May 9, 2010

First Submission Date that Met QC Criteria

May 13, 2010

First Posted Date

May 14, 2010Estimated

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

Nov 12, 2010

Last Update Posted Date

Nov 16, 2010Estimated

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

The purpose of this study is to determine how often ventilator associated pneumonia happens in the current intensive care units, and how types of endotracheal tube affect its occurrence.

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

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ventilator associated pneumonia			Device: Choice of endotracheal tube
No pneumonia			Device: Choice of endotracheal tube

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Choice of endotracheal tube	Device	Types of endotracheal tube, normal cuff without sub-glottic aspiration, normal cuff with sub-glottic aspiration, Special cuff with sub-glottic aspiration

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Occurrence and timing of ventilator associated pneumonia	From tracheal intubation to ICU duscharge	one month

Secondary Outcomes

Measure	Description	Time Frame
Ventilator-free days	During ICU stay	one month
Duration of ICU stay and hospital stay	From tracheal intubation to ICU or hospital discharge

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age > 20 years old
Mechanically ventilated over 48 hours in the ICU

Exclusion Criteria:

Mask ventilation
Tracheostomy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Critically ill patients in an intensive care unit

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hiroshi Morimatsu, MD, Ph D	Okayama University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Intensive Care Unit, Himeji Red Cross Hospital		Himeji	Hyōgo		Japan
Intensive Care Unit, Hiroshima City Hospital

Label	URL
This is the study homepage written in Japanese.	View source

Condition Browse Module

MeSH Terms

ID	Term
D053717	Pneumonia, Ventilator-Associated
D016638	Critical Illness
D053120	Respiratory Aspiration

Ancestor Terms

ID	Term
D000077299	Healthcare-Associated Pneumonia
D003428	Cross Infection
D007239	Infections
D011014	Pneumonia

Browse Leaves

Not provided

Browse Branches

Not provided