Evaluating the Effectiveness of the Tongue Cleaner in Critical Patients

Ventilator-associated Pneumonia Clinical Trial

Official title:

Evaluating the Effectiveness of the Tongue Cleaner in Patients Wholly or Partially Dependent Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01294943
• Other study ID #: Bauru School of Dentistry, USP
• Status: Completed
• Phase: N/A
• First received: February 11, 2011
• Last updated: August 14, 2012
• Start date: January 2010
• Est. completion date: December 2011

Study information

• Verified date: August 2012
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Oral Infection
• Pneumonia
• Pneumonia, Ventilator-Associated
• Ventilator-associated Pneumonia

Intervention

Device:
• Tongue cleaner
Use of the tongue cleaner (TePe ®) to remove the tongue biofilm in patients on mechanical ventilation.

Locations

Country	Name	City	State
Brazil	Hospital Santa Cruz	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil,