Effectiveness of Dental Brushing for Preventing Ventilator-Associated Pneumonia - Full Text View

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

First Received on February 11, 2009. No Changes Posted

Sponsor:	Hospital Universitari Joan XXIII de Tarragona.
Information provided by:	Hospital Universitari Joan XXIII de Tarragona.
ClinicalTrials.gov Identifier:	NCT00842478

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 II Phase III

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:

MedlinePlus related topics: Pneumonia

U.S. FDA Resources

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

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):

Pobo A, Lisboa T, Rodriguez A, Sole R, Magret M, Trefler S, Gómez F, Rello J; RASPALL Study Investigators. A randomized trial of dental brushing for preventing ventilator-associated pneumonia. Chest. 2009 Aug;136(2):433-9. Epub 2009 May 29.

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 February 09, 2012