Evaluating the Effectiveness of the Tongue Cleaner in Critical Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Paulo Sergio da Silva Santos, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01294943
First received: February 11, 2011
Last updated: August 14, 2012
Last verified: August 2012
  Purpose

The concern with oral infection and its systemic repercussions is old, many studies have been undertaken to establish this relationship more precisely. One of the areas mouth still little studied in this regard is the colonization of language within this universe of the oral microbiota colonization and how this may affect the general state of health care-dependent individuals.

This research aims to evaluate the efficiency of a tongue cleaning device and its potential impacts on infectious patients fully or partially dependent care hospital.

Patients admitted to intensive care units and inpatient units will be evaluated, divided into two groups: Study Group (SG) - Patients who receive oral hygiene using the tongue cleaning device, and Control Group (CG) - Patients who are cared for according to the routine of hospital nursing.


Condition Intervention
Oral Infection
Ventilator-associated Pneumonia
Device: Tongue cleaner

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Evaluating the Effectiveness of the Tongue Cleaner in Patients Wholly or Partially Dependent Care

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Biospecimen Retention:   Samples Without DNA

tongue biofilm


Enrollment: 50
Study Start Date: January 2010
Study Completion Date: December 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Tongue cleaner
Use of the tongue cleaner (TePe ®) to remove the tongue biofilm in patients on mechanical ventilation.
Device: Tongue cleaner
Use of the tongue cleaner (TePe ®) to remove the tongue biofilm in patients on mechanical ventilation.

Detailed Description:

Patients admitted to intensive care units and inpatient units will be evaluated, divided into two groups: Study Group (SG) - Patients who receive oral hygiene using the tongue cleaning device, and Control Group (CG) - Patients who are cared for According to the routine of hospital nursing.

The criteria for inclusion of elements of the research will follow the criteria of dependence of patients on mechanical ventilation, if they are or not. Patients fully or partially dependent care are patients who can not make your oral hygiene alone and dependent on another individual to do so, if a hospital staff member health. Exclusion criteria will be based on condition of dependency of the patient, intubation period under 48 hours and if one refuses to participate in the research.

Patients will first be evaluated by a dentist, doctor and nursing, which together decide on the inclusion of patients in the study based on the criterion of seriousness of the patient by APACHE. The assessment will follow the clinical criterion of presence or absence of tongue biofilm (Adachi 2005), and the collection swab with biofilm lingual to perform culture and sensitivity. These assessments take place twice within five days, being held in the first and fifth days. During this period the patients participating in the GE will hygienic tongue using tongue cleaner (Tepe ®) and other standardized oral hygiene care by the nursing team previously coached by dentist. CG patients receive the standard oral hygiene care with a spatula and gauze soaked in mouthwash and tongue will not use the tongue cleaner.

For the assessment of plaque and tongue of sample qualitative material for culture and sensitivity attend three calibrated dentists.

For this study 25 patients will be assessed for EG and 25 for GC, a total of 50 patients evaluated, and 100 samples of material collected.

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients undergoing intubation in the intensive care unit

Criteria

Inclusion Criteria:

  • The criteria for inclusion of elements of the research will follow the criteria of dependence of patients on mechanical ventilation they are or not. Patients fully or partially dependent care are patients who can not make your oral hygiene alone and dependent on another individual to do so, if a hospital staff member health.

Exclusion Criteria:

  • Condition of not being dependent on the patient
  • Intubation period under 48 hours
  • If one refuses to participate in the research
  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: NCT01294943

Locations
Brazil
Hospital Santa Cruz
São Paulo, Brazil, 04122-000
Sponsors and Collaborators
University of Sao Paulo
  More Information

No publications provided

Responsible Party: Paulo Sergio da Silva Santos, DDS, MD, PhD, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01294943     History of Changes
Other Study ID Numbers: Bauru School of Dentistry, USP
Study First Received: February 11, 2011
Last Updated: August 14, 2012
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo:
Intensive Care Units
Biofilms
Tongue
Infection
Pneumonia/Aspiration

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 July 22, 2014