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Effectiveness of Dental Brushing for Preventing Ventilator-Associated Pneumonia (RASPALL)

Primary Purpose

Ventilator-Associated Pneumonia, Nosocomial Pneumonia, Pneumonia

Status

Unknown status

Phase

Phase 2

Locations

Spain

Study Type

Interventional

Intervention

Toothbrushing

About this trial

This is an interventional prevention trial for Ventilator-Associated Pneumonia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

ICU, Hospital Universitari Joan XXIIIRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Raspall

Control

Arm Description

Outcomes

Primary Outcome Measures

Ventilator-Associated Pneumonia (VAP)

Secondary Outcome Measures

Full Information

NCT ID

NCT00842478

First Posted

February 11, 2009

Last Updated

February 11, 2009

Sponsor

Hospital Universitari Joan XXIII de Tarragona.

1. Study Identification

Unique Protocol Identification Number

NCT00842478

Brief Title

Effectiveness of Dental Brushing for Preventing Ventilator-Associated Pneumonia

Acronym

RASPALL

Official Title

Effectiveness of Dental Brushing for Preventing Ventilator-Associated Pneumonia

Study Type

Interventional

2. Study Status

Record Verification Date

February 2009

Overall Recruitment Status

Unknown status

Study Start Date

May 2005 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Hospital Universitari Joan XXIII de Tarragona.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ventilator-Associated Pneumonia, Nosocomial Pneumonia, Pneumonia

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Raspall

Arm Type

Experimental

Arm Title

Control

Arm Type

No Intervention

Intervention Type

Procedure

Intervention Name(s)

Toothbrushing

Primary Outcome Measure Information:

Title

Ventilator-Associated Pneumonia (VAP)

Time Frame

28 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Angel Pobo, MD

Phone

34 977 295818

angel.pobo@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jordi Rello, MD, PhD

Organizational Affiliation

Hospital Universitari Joan XXIII

Official's Role

Principal Investigator

Facility Information:

Facility Name

ICU, Hospital Universitari Joan XXIII

City

Tarragona

ZIP/Postal Code

43005

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Angel Pobo, MD

Phone

34 977295818

angel.pobo@gmail.com

First Name & Middle Initial & Last Name & Degree

Angel Pobo, MD

First Name & Middle Initial & Last Name & Degree

Jordi Rello, MD, PhD

12. IPD Sharing Statement

Citations:

PubMed Identifier

19482956

Citation

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.

Results Reference

derived

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Effectiveness of Dental Brushing for Preventing Ventilator-Associated Pneumonia

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