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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Hospital Universitari Joan XXIII de Tarragona..
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Hospital Universitari Joan XXIII de Tarragona.
ClinicalTrials.gov Identifier:
NCT00842478
First received: February 11, 2009
Last updated: NA
Last verified: February 2009
History: No changes posted
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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 ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Hospital Universitari Joan XXIII de Tarragona.

Additional 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
Study First Received: February 11, 2009
Last Updated: February 11, 2009
Health Authority: Spain: Comité Ético de Investigación Clínica

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

ClinicalTrials.gov processed this record on September 14, 2014