Evaluating the Effectiveness of the Tongue Cleaner in Critical Patients

NCT01294943 | Completed DMC

• 1 other identifier: Bauru School of Dentistry, USP
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Oral Infection; Ventilator-associated Pneumonia

Keywords

Intensive Care Units; Biofilms; Tongue; Infection; Pneumonia/Aspiration

Study Arms (1)

Tongue cleaner

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

Device: Tongue cleaner

Interventions

Tongue cleaner DEVICE

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

Tongue cleaner

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients undergoing intubation in the intensive care unit

You may not qualify if:

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

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Hospital Santa Cruz

São Paulo, São Paulo, 04122-000, Brazil

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

tongue biofilm

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated; Infections; Pneumonia, Aspiration

Condition Hierarchy (Ancestors)

Healthcare-Associated Pneumonia; Cross Infection; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DDS, MD, PhD

Study Record Dates

• First Submitted: February 11, 2011
• First Posted: February 14, 2011
• Study Start: January 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: December 1, 2011
• Last Updated: August 15, 2012

Record last verified: 2012-08

Locations

BR (1)