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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 22, 2014