Time Interval for Changing Closed System Suction Catheter... | NCT00447109

Studies
Time Interval for Changing Closed System Suction Catheters, Effect on Ventilator Associated Pneumonia

NCT00447109

Sponsor

Bayside Health

Status

Completed

Last Update Posted

Mar 14, 2007Estimated

Enrollment

344

Phase

Not Applicable

Conditions

Pneumonia, Ventilator Associated
Closed System Suction Catheter

Interventions

Closed system suction

Countries

Australia

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

ID	Type	Description	Link
T10308

Status Module

Record Verification Date

Mar 2007

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

Sep 2003

Primary Completion Date

Not provided

Completion Date

Apr 2004

First Submitted Date

Mar 12, 2007

First Submission Date that Met QC Criteria

Mar 13, 2007

First Posted Date

Mar 14, 2007Estimated

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

Mar 13, 2007

Last Update Posted Date

Mar 14, 2007Estimated

Name	Class
Deakin University	OTHER

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 was to compare the incidence of ventilator-associated pneumonia between two groups of patients randomised to have closed system suction catheter changes every 24 hours and patients having closed system suction catheter changes every seven days or as required.

Detailed Description

Comparison(s): the incidence of ventilator-associated pneumonia between two groups of patients randomised to have closed system suction catheter changes every 24 hours and patients having closed system suction catheter changes every seven days or as required.

Design Module

Study Type

Interventional

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 Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

344

Name	Type	Description	Arm Group Labels	Other Names
Closed system suction	Device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
ventilator-associated pneumonia

Secondary Outcomes

Measure	Description	Time Frame
length of hospital
intensive care stay
duration of mechanical ventilation

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Aged greater than 18 years
Mechanically ventilated for more than 24 hours

Exclusion Criteria:

Admitted from other hospital already mechanically ventilated
Massive haemoptysis
Previously received mechanical ventilation

Accepts Healthy Volunteers

Yes

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lauren J McTier	Deakin University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Alfred Hospital		Melbourne	Victoria	3181	Australia

Condition Browse Module

MeSH Terms

ID	Term
D053717	Pneumonia, Ventilator-Associated

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided