Evaluating the Effectiveness of the Tongue Cleaner in Critical Patients
| Tracking Information | |
|---|---|
| First Received Date ICMJE | February 11, 2011 |
| Last Updated Date | August 14, 2012 |
| Start Date ICMJE | January 2010 |
| Primary Completion Date | June 2011 (final data collection date for primary outcome measure) |
| Current Primary Outcome Measures ICMJE | Not Provided |
| Original Primary Outcome Measures ICMJE | Not Provided |
| Change History | Complete list of historical versions of study NCT01294943 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | Not Provided |
| Original Secondary Outcome Measures ICMJE | Not Provided |
| Current Other Outcome Measures ICMJE | Not Provided |
| Original Other Outcome Measures ICMJE | Not Provided |
| Descriptive Information | |
| Brief Title ICMJE | Evaluating the Effectiveness of the Tongue Cleaner in Critical Patients |
| Official Title ICMJE | Evaluating the Effectiveness of the Tongue Cleaner in Patients Wholly or Partially Dependent Care |
| Brief 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. |
| 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. |
| Study Type ICMJE | Observational |
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Prospective |
| Target Follow-Up Duration | Not Provided |
| Biospecimen | Retention: Samples Without DNA Description: tongue biofilm |
| Sampling Method | Probability Sample |
| Study Population | Patients undergoing intubation in the intensive care unit |
| Condition ICMJE |
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| Intervention ICMJE | Device: Tongue cleaner
Use of the tongue cleaner (TePe ®) to remove the tongue biofilm in patients on mechanical ventilation. |
| Study Group/Cohort (s) | Tongue cleaner
Use of the tongue cleaner (TePe ®) to remove the tongue biofilm in patients on mechanical ventilation.
Intervention: Device: Tongue cleaner |
| Publications * | Not Provided |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | 50 |
| Completion Date | December 2011 |
| Primary Completion Date | June 2011 (final data collection date for primary outcome measure) |
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both |
| Ages | 15 Years and older |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | Brazil |
| Administrative Information | |
| NCT Number ICMJE | NCT01294943 |
| Other Study ID Numbers ICMJE | Bauru School of Dentistry, USP |
| Has Data Monitoring Committee | Yes |
| Responsible Party | Paulo Sergio da Silva Santos, University of Sao Paulo |
| Study Sponsor ICMJE | University of Sao Paulo |
| Collaborators ICMJE | Not Provided |
| Investigators ICMJE | Not Provided |
| Information Provided By | University of Sao Paulo |
| Verification Date | August 2012 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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