Back to resultsToothbrushing and Ventilator-associated Pneumonia
Primary Purpose
Ventilator Associated Pneumonia
Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Toothbrushing with a manual brush
Sponsored by
About this trial
This is an interventional prevention trial for Ventilator Associated Pneumonia
Eligibility Criteria
Inclusion Criteria:
- mechanical ventilation
Exclusion Criteria:
- edentulous
Sites / Locations
- Leonardo Lorente
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Toothbrushing with a manual brush
No toothbrushing
Arm Description
Toothbrushing with a manual brush
no toothbrushing
Outcomes
Primary Outcome Measures
Prevention of ventilator-associated pneumonia
Secondary Outcome Measures
Full Information
NCT ID
NCT01477099
First Posted
November 16, 2011
Last Updated
November 18, 2011
Sponsor
Hospital Universitario de Canarias
1. Study Identification
Unique Protocol Identification Number
NCT01477099
Brief Title
Toothbrushing and Ventilator-associated Pneumonia
Official Title
Efficacy of Toothbrushing for the Prevention of Ventilator-associated Pneumonia
Study Type
Interventional
2. Study Status
Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Universitario de Canarias
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventilator Associated Pneumonia
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
436 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Toothbrushing with a manual brush
Arm Type
Experimental
Arm Description
Toothbrushing with a manual brush
Arm Title
No toothbrushing
Arm Type
No Intervention
Arm Description
no toothbrushing
Intervention Type
Device
Intervention Name(s)
Toothbrushing with a manual brush
Intervention Description
Toothbrushing with a manual brush
Primary Outcome Measure Information:
Title
Prevention of ventilator-associated pneumonia
Time Frame
60 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
mechanical ventilation
Exclusion Criteria:
edentulous
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leonardo Lorente, Medical
Organizational Affiliation
Hospital Universitario de Canarias
Official's Role
Principal Investigator
Facility Information:
Facility Name
Leonardo Lorente
City
La Laguna
State/Province
Tenerife
ZIP/Postal Code
38320
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
22422274
Citation
Lorente L, Lecuona M, Jimenez A, Palmero S, Pastor E, Lafuente N, Ramos MJ, Mora ML, Sierra A. Ventilator-associated pneumonia with or without toothbrushing: a randomized controlled trial. Eur J Clin Microbiol Infect Dis. 2012 Oct;31(10):2621-9. doi: 10.1007/s10096-012-1605-y. Epub 2012 Mar 16.
Results Reference
derived
Learn more about this trial
Toothbrushing and Ventilator-associated Pneumonia
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