Toothbrushing and Ventilator-associated Pneumonia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Miriam Cervino, Hospital Universitario de Canarias
ClinicalTrials.gov Identifier:
NCT01477099
First received: November 16, 2011
Last updated: November 18, 2011
Last verified: November 2011
  Purpose

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 Intervention Phase
Ventilator Associated Pneumonia
Device: Toothbrushing with a manual brush
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Efficacy of Toothbrushing for the Prevention of Ventilator-associated Pneumonia

Resource links provided by NLM:


Further study details as provided by Hospital Universitario de Canarias:

Primary Outcome Measures:
  • Prevention of ventilator-associated pneumonia [ Time Frame: 60 days ] [ Designated as safety issue: No ]

Enrollment: 436
Study Start Date: August 2010
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • mechanical ventilation

Exclusion Criteria:

  • edentulous
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided by Hospital Universitario de Canarias

Additional 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
Study First Received: November 16, 2011
Last Updated: November 18, 2011
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 April 14, 2014