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Toothbrushing and Ventilator-associated Pneumonia

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ClinicalTrials.gov Identifier: NCT01477099
Recruitment Status : Completed
First Posted : November 22, 2011
Last Update Posted : November 22, 2011
Sponsor:
Information provided by (Responsible Party):
Miriam Cervino, Hospital Universitario de Canarias

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.

Condition or disease Intervention/treatment Phase
Ventilator Associated Pneumonia Device: Toothbrushing with a manual brush Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 436 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Efficacy of Toothbrushing for the Prevention of Ventilator-associated Pneumonia
Study Start Date : August 2010
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Toothbrushing with a manual brush
Toothbrushing with a manual brush
Device: Toothbrushing with a manual brush
Toothbrushing with a manual brush
No Intervention: No toothbrushing
no toothbrushing



Primary Outcome Measures :
  1. Prevention of ventilator-associated pneumonia [ Time Frame: 60 days ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • mechanical ventilation

Exclusion Criteria:

  • edentulous

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01477099


Locations
Spain
Leonardo Lorente
La Laguna, Tenerife, Spain, 38320
Sponsors and Collaborators
Hospital Universitario de Canarias
Investigators
Principal Investigator: Leonardo Lorente, Medical Hospital Universitario de Canarias

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Miriam Cervino, Medical Doctor, Hospital Universitario de Canarias
ClinicalTrials.gov Identifier: NCT01477099     History of Changes
Other Study ID Numbers: BRUSH-2009
First Posted: November 22, 2011    Key Record Dates
Last Update Posted: November 22, 2011
Last Verified: November 2011

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