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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2009 by Hospital Universitari Joan XXIII de Tarragona..
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00842478
First Posted: February 12, 2009
Last Update Posted: February 12, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hospital Universitari Joan XXIII de Tarragona.
  Purpose
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.

Condition Intervention Phase
Ventilator-Associated Pneumonia Nosocomial Pneumonia Pneumonia Procedure: Toothbrushing Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: Effectiveness of Dental Brushing for Preventing Ventilator-Associated Pneumonia

Resource links provided by NLM:


Further study details as provided by Hospital Universitari Joan XXIII de Tarragona.:

Primary Outcome Measures:
  • Ventilator-Associated Pneumonia (VAP) [ Time Frame: 28 days ]

Estimated Enrollment: 400
Study Start Date: May 2005
Arms Assigned Interventions
Experimental: Raspall Procedure: Toothbrushing
No Intervention: Control

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00842478


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

Locations
Spain
ICU, Hospital Universitari Joan XXIII Recruiting
Tarragona, Spain, 43005
Contact: Angel Pobo, MD    34 977295818    angel.pobo@gmail.com   
Sub-Investigator: Angel Pobo, MD         
Principal Investigator: Jordi Rello, MD, PhD         
Sponsors and Collaborators
Hospital Universitari Joan XXIII de Tarragona.
Investigators
Principal Investigator: Jordi Rello, MD, PhD Hospital Universitari Joan XXIII
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jordi Rello, Hospital Universitari Joan XXIII
ClinicalTrials.gov Identifier: NCT00842478     History of Changes
Other Study ID Numbers: FIS 06/0060
First Submitted: February 11, 2009
First Posted: February 12, 2009
Last Update Posted: February 12, 2009
Last Verified: February 2009

Additional relevant MeSH terms:
Pneumonia
Pneumonia, Ventilator-Associated
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Cross Infection
Infection
Ventilator-Induced Lung Injury
Lung Injury