Effectiveness of Dental Brushing for Preventing Ventilato... | NCT00842478

Studies
Effectiveness of Dental Brushing for Preventing Ventilator-Associated Pneumonia

NCT00842478

Sponsor

Hospital Universitari Joan XXIII de Tarragona.

Status

Unknown status

Last Update Posted

Feb 12, 2009Estimated

Enrollment

400Estimated

Phase

Phase 2Phase 3

Conditions

Ventilator-Associated Pneumonia
Nosocomial Pneumonia
Pneumonia

Interventions

Toothbrushing

Countries

Spain

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

Feb 2009

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

May 2005

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Feb 11, 2009

First Submission Date that Met QC Criteria

Feb 11, 2009

First Posted Date

Feb 12, 2009Estimated

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

Feb 11, 2009

Last Update Posted Date

Feb 12, 2009Estimated

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

Poor oral hygiene is associated with respiratory pathogen colonization and secondary lung infection.The possible association between oral care and incidence of VAP, and the role of dental plaque, mouth and tracheal colonization have not been firmly established. The investigators' hypothesis was that improving oral care with electrical toothbrushing might be effective in reducing the incidence of VAP.

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 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

400Estimated

Label	Type	Description	Intervention Names
Raspall	Experimental		Procedure: Toothbrushing
Control	No Intervention

Name	Type	Description	Arm Group Labels	Other Names
Toothbrushing	Procedure		Raspall

Measure	Description	Time Frame
Ventilator-Associated Pneumonia (VAP)		28 days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult intubated patients
Without evidence of pulmonary infection (randomized within 12h of intubation if they were expected to remain ventilated for longer than 48 hours)

Exclusion Criteria:

Absence of dental pieces
Current diagnosis of pneumonia or massive bronchoaspiration
Tracheostomy (or expected within 48 hours)
Chlorhexidine allergy

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
Angel Pobo, MD	Contact	34 977 295818		angel.pobo@gmail.com

Overall Officials

Name	Affiliation	Role
Jordi Rello, MD, PhD	Hospital Universitari Joan XXIII	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
ICU, Hospital Universitari Joan XXIII	Recruiting	Tarragona	Tarragona	43005	Spain

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19482956	Derived	Pobo A, Lisboa T, Rodriguez A, Sole R, Magret M, Trefler S, Gomez F, Rello J; RASPALL Study Investigators. A randomized trial of dental brushing for preventing ventilator-associated pneumonia. Chest. 2009 Aug;136(2):433-439. doi: 10.1378/chest.09-0706. Epub 2009 May 29.

ID	Term
D053717	Pneumonia, Ventilator-Associated
D000077299	Healthcare-Associated Pneumonia
D011014	Pneumonia

ID	Term
D003428	Cross Infection
D007239	Infections
D012141	Respiratory Tract Infections
D008171	Lung Diseases

ID	Term
D009910	Oral Hygiene
D011313	Preventive Dentistry
D003813	Dentistry