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NCT00842478 Clinical Trial

Effectiveness of Dental Brushing for Preventing Ventilator-Associated Pneumonia

Pneumonia Clinical Trial

— RASPALL  

Official title:
Effectiveness of Dental Brushing for Preventing Ventilator-Associated Pneumonia

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00842478
Other study ID # FIS 06/0060
Secondary ID
Status Recruiting
Phase Phase 2/Phase 3
First received February 11, 2009
Last updated February 11, 2009
Start date May 2005

Study information
Verified date February 2009
Source Hospital Universitari Joan XXIII de Tarragona.
Contact Angel Pobo, MD
Phone 34 977 295818
Email angel.pobo@gmail.com
Is FDA regulated No
Health authority Spain: Comité Ético de Investigación Clínica
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 400
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Procedure:
• Toothbrushing

Locations
Country Name City State
Spain ICU, Hospital Universitari Joan XXIII Tarragona

Sponsors (1)
Lead Sponsor Collaborator
Hospital Universitari Joan XXIII de Tarragona.

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Ventilator-Associated Pneumonia (VAP) 28 days No
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