Oral Care and Gram-negative Pathogen in Children

Federal University of São Paulo

Status: Completed

Conditions: Tracheal and Oropharyngeal Colonization by Gram-negative Pathogens

Treatments: Other: 0,12% digluconate chlorhexidine; Other: toothbrushing

Study type: Interventional

Funder types: Other

Identifiers

NCT01410682

ORAL CARE

Details and patient eligibility

About

Critical care nursing interventions related to oral care can reduce the microorganisms in the oropharynx available for translocation to other sites. THis is a randomized, controlled and double blinded study performed in a pediatric intensive care unit (PICU) from a Brazilian university hospital which objectives were to analyze 0.12% chlorhexidine digluconate influence on Gram-negative pathogens colonization of oropharyngeal and tracheal secretions of mechanically ventilated children.

Enrollment: 74 patients

Sex: All

Ages: 29 days to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All the PICU children during 24 months of study were selected for participation.

Exclusion criteria

• newborns, those that fulfilled the Centers for Disease Control and Prevention criteria for pneumonia in infants and children at the time of PICU admission, PICU LOS less than 48 hours, presence of tracheostomy and those that declined to participate.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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74 participants in 2 patient groups, including a placebo group

0.12% Chlorhexidine Digluconate

Experimental group

Description:

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.

Treatment:

Other: 0,12% digluconate chlorhexidine

tothbrushing

Placebo Comparator group

Description:

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 posterior to anterior movements.

Treatment:

Other: toothbrushing