Oral Care Interventions and Ventilator Associated Pneumonia in Critically Ill Children

Phase 1

Completed

• Conditions: Ventilator Associated Pneumonia
• Interventions: Drug: 0.12% Chlorhexidine Digluconate; Other: Toothbrushing

• Registration Number: NCT01083407
• Lead Sponsor: Federal University of São Paulo

Brief Summary

This experimental study aims to verify the influence of the oral hygiene performance with chlorhexidine digluconate 0.12% in the development of VAP in children. The data collection begun in April, 2005 during the performance of the masters degree course dissertation entitled "Clinical study about the effect of the oral hygiene with chlorhexidine digluconate 0.12% in the oropharynx colonization of children in intensive care", being performed in a PICU of nine beds in a university hospital in the city of São Paulo, after approval of the Research Ethics Committee of the institution. The study is composed by three types of variables: Independent variable, dependent variables, and complementary variables. The categorical variables will be analyzed in accordance with the Person's Chi-Square test of or Fisher's exact test. The numerics will be submitted to the analysis of variance ANOVA or Kruskall Wallis. For variables with heterogeneous distribution between the groups, the multivariate analysis will be applied to the evaluation of the influence in the determination of the development risk of the dependent variable. The rejection level will be fixed in 0.05 of the nullity hypothesis.

Detailed Description

Recent progress in identification of oral microorganisms has shown that the oropharynx can be a site of origin for dissemination of pathogenic organisms to distant body sites, such as the lungs. THe aims of the study were to compare the oropharyngeal microbiological profile, VAP incidence, duration of mechanical ventilation, and length of stay in the intensive care unit of children receiving mechanical ventilation who had pharmacological or nonpharmacological oral care.

A randomized and controlled study has been performed in a pediatric intensive unit in São Paulo, Brazil. The children are randomly assigned to an experimental group that received oral care with use of 0.12% chlorhexidine digluconate or a control group that received oral care without an antiseptic. Oropharyngeal and tracheal secretions were collected and cultured on days 0, 2, and 4, and at discharge.

Study Timeline

• Study Start: 2005-06
• Primary Completion: 2006-06
• Study Completion: 2008-06
• Status Verified: 2009-03
• Study First Submitted: 2010-03-05
• Study First Submitted QC: 2010-03-08
• Last Update Submitted: 2010-03-08
• Study First Posted: 2010-03-09
• Last Update Posted: 2010-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 146

Inclusion Criteria

• Critically ill children.
• Age: 29 days to 18 years.

Exclusion Criteria

• Newborn age.
• Pneumonia at PICU admission.
• Tracheostomy.
• Tracheal intubation higher than 24 hours in the PICU admission.
• PICU LOS lower than 48 hours.
• Responsibles declined consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
0.12% Chlorhexidie Digluconate	0.12% Chlorhexidine Digluconate	Oral care included use of an oral gel containing chlorhexidine digluconate 0.12% as an active ingredient (chlorhexidine digluconate 0.12%; methylcellulose gel 2.12%, 25 g; gooseberry syrup, 4 drops; menthol solution 50%,3 drops; and distilled water, to 30 g).The gel is applied on a toothbrush, and the teeth are cleaned in quadrants; all teeth surfaces are cleaned (vestibular,lingual, occlusal, and incisal). After each quadrant was cleaned, 10 mL of water (dispensed via a syringe) is used to rinse the quadrant and continual aspiration is used to remove all the gel and debris. After all the teeth are cleaned, the ventral surface of the tongue is brushed with posteriorto- anterior movements.
Toothbrushing	Toothbrushing	This group received the same oral care that experimental group with the use of a similarly formulated gel without the antiseptic agent.The gel is applied on a toothbrush, and the teeth are cleaned in quadrants; all teeth surfaces are cleaned (vestibular, lingual, occlusal, and incisal). After each quadrant is cleaned, 10 mL of water (dispensed via a syringe) is used to rinse the quadrant and continual aspiration is used to remove all the gel and debris. After all the teeth are cleaned, the ventral surface of the tongue is brushed with posteriorto-anterior movements.

Primary Outcome Measures

Name	Time	Method
Ventilator associated pneumonia	48 hours after tracheal intubation	Influence of oral care with 0.12% chlorhexidine on VAP incidence diagnosed by clinical pulmonary infection score.

Secondary Outcome Measures

Name	Time	Method
PICU Lengh of Stay	Necessary days to PICU discharge	Influence of oral care with 0.12% chlorhexidine on PICU LOS
Time of Mechanical pulmonary ventilation	Last day of MPV	Influence of oral care with 0.12% chlorhexidine on time of mechanical ventilation.