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NCT01477099 Clinical Trial

Toothbrushing and Ventilator-associated Pneumonia

Ventilator Associated Pneumonia Clinical Trial

Official title:
Efficacy of Toothbrushing for the Prevention of Ventilator-associated Pneumonia

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01477099
Other study ID # BRUSH-2009
Secondary ID
Status Completed
Phase Phase 4
First received November 16, 2011
Last updated November 18, 2011
Start date August 2010
Est. completion date August 2011

Study information
Verified date November 2011
Source Hospital Universitario de Canarias
Contact n/a
Is FDA regulated No
Health authority Spain: Comité Ético de Investigación Clínica
Study type Interventional

Clinical Trial Summary

The hypothesis is that adding the toothbrushing to the oral care with clorhexidine 0.12% could be reduce the incidence of ventilator-associated pneumonia due to that oral cavity may be an important reservoir of pathogens that could cause pneumonia.

Recruitment information / eligibility
Status Completed
Enrollment 436
Est. completion date August 2011
Est. primary completion date August 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- mechanical ventilation

Exclusion Criteria:

- edentulous

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Device:
• Toothbrushing with a manual brush
Toothbrushing with a manual brush

Locations
Country Name City State
Spain Leonardo Lorente La Laguna Tenerife

Sponsors (1)
Lead Sponsor Collaborator
Hospital Universitario de Canarias

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Prevention of ventilator-associated pneumonia 60 days No
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