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

February 11, 2009 updated by: Hospital Universitari Joan XXIII de Tarragona.
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
      • Tarragona, Spain, 43005
        • Recruiting
        • ICU, Hospital Universitari Joan XXIII
        • Contact:
        • Sub-Investigator:
          • Angel Pobo, MD
        • Principal Investigator:
          • Jordi Rello, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Control
EXPERIMENTAL: Raspall
Procedure: Toothbrushing

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitari Joan XXIII de Tarragona.

Investigators

  • Principal Investigator: Jordi Rello, MD, PhD, Hospital Universitari Joan Xxiii

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2005

Study Registration Dates

First Submitted

February 11, 2009

First Submitted That Met QC Criteria

February 11, 2009

First Posted (ESTIMATE)

February 12, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

February 12, 2009

Last Update Submitted That Met QC Criteria

February 11, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FIS 06/0060

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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