NCT00842478

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.

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2005

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

February 11, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 12, 2009

Completed
Last Updated

February 12, 2009

Status Verified

February 1, 2009

First QC Date

February 11, 2009

Last Update Submit

February 11, 2009

Conditions

Ventilator-Associated PneumoniaNosocomial PneumoniaPneumonia

Outcome Measures

Primary Outcomes (1)

  • Ventilator-Associated Pneumonia (VAP)

    28 days

Study Arms (2)

Raspall

EXPERIMENTAL
Procedure: Toothbrushing

Control

NO INTERVENTION

Interventions

ToothbrushingPROCEDURE
Raspall

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ICU, Hospital Universitari Joan XXIII

Tarragona, Tarragona, 43005, Spain

RECRUITING

Related Publications (1)

  • 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.

    PMID: 19482956DERIVED

MeSH Terms

Conditions

Pneumonia, Ventilator-AssociatedHealthcare-Associated PneumoniaPneumonia

Interventions

Toothbrushing

Condition Hierarchy (Ancestors)

Cross InfectionInfectionsRespiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Oral HygienePreventive DentistryDentistry

Study Officials

  • Jordi Rello, MD, PhD

    Hospital Universitari Joan XXIII

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Angel Pobo, MD

CONTACT

34 977 295818angel.pobo@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 11, 2009

First Posted

February 12, 2009

Study Start

May 1, 2005

Last Updated

February 12, 2009

Record last verified: 2009-02

Locations

ES(1)