Ventilator-associated Pneumonia (VAP) and Humidification... | NCT01546974

Studies
Ventilator-associated Pneumonia (VAP) and Humidification System

NCT01546974

Sponsor

Hospital Sao Domingos

Status

Unknown status

Last Update Posted

Mar 7, 2012Estimated

Enrollment

306Estimated

Phase

Phase 4

Conditions

Ventilator-associated Pneumonia

Interventions

HME filter Twin Star 55, Drager Medical, Germany
Heated humidification

Countries

Brazil

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
CEP026/2011	Other Identifier	Hospital Sao Domingos

Status Module

Record Verification Date

Jan 2012

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

Nov 2011

Primary Completion Date

Nov 2013Estimated

Completion Date

Feb 2014Estimated

First Submitted Date

Mar 3, 2012

First Submission Date that Met QC Criteria

Mar 6, 2012

First Posted Date

Mar 7, 2012Estimated

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 6, 2012

Last Update Posted Date

Mar 7, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

José Raimundo Araujo de Azevedo, Coordinator ICU, Hospital Sao DomingosPrincipal Investigator

Lead Sponsor

Hospital Sao DomingosOTHER

Collaborators

Not provided

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

The purpose of this study is to determine which humidification system is more effective in preventing pneumonia in mechanically ventilated patients. The study will compare a heat and moisture exchanger versus heated humidification.

Detailed Description

Not provided

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

306Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
HME filter	Experimental		Device: HME filter Twin Star 55, Drager Medical, Germany
Heated humidificator MR 730 Fisher & Paykel	Experimental		Device: Heated humidification

Interventions

Name	Type	Description	Arm Group Labels	Other Names
HME filter Twin Star 55, Drager Medical, Germany	Device		HME filter
Heated humidification

Measure	Description	Time Frame
VAP incidence

Measure	Description	Time Frame
Duration of mechanical ventilation

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients expected to require mechanical ventilation for at least 48 hours

Exclusion Criteria:

Patients < 18 yo and pregnant

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
JOSE R AZEVEDO, MD	Contact	55 98 32168110		jrazevedo@elo.com.br

Overall Officials

Name	Affiliation	Role
JOSE R AZEVEDO, MD	Director ICU	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Sao Domingos	Recruiting	São Luís	Maranhão	65060-000	Brazil

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