Oral Hygiene With Chlorhexidine and Incidence of Ventilator-Associated Pneumonia in Children Submitted to Heart Surgery

University of Sao Paulo

Status and phase: Completed; Phase 3

Conditions: Heart Surgery; Ventilator Associated Pneumonia; Nosocomial Pneumonia

Treatments: Other: placebo; Other: oral hygiene

Study type: Interventional

Funder types: Other

Identifiers

NCT00829842

HCRP 8904/2005

Details and patient eligibility

About

Hospital infections play an important role in the increase of patients' morbimortality and hospitalization costs, especially in the case of individuals admitted to intensive care units (ICU) during postoperative heart surgery. Analysis of the epidemiological profile of the hospital infections in the pediatric-ICU (P-ICU) of Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto, University of São Paulo (HCFMRP-USP) demonstrated a 31.1% incidence of pneumonia (PNM) and a rate of ventilator-associated pneumonia (VAP) of 23.81 per 1000 ventilators-day between March 2004 and February 2005 in the group submitted to cardiac surgery. Knowledge of the pathophysiology and risk factors associated with this infection allows for measures aiming at reducing its incidence. The objective of the present study is to evaluate the effect of oral hygiene with a 0.12% chlorhexidine solution on the incidence of PNM and PAV in children submitted to cardiac surgery.

Enrollment: 160 patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age 0 to 18 years submitted to heart surgery
• parent approval

Exclusion criteria

• previous oral intubation
• previous or present pneumonia
• parent refusal
• death during surgery

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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160 participants in 2 patient groups, including a placebo group

1

Placebo Comparator group

Description:

Placebo

Treatment:

Other: placebo

2

Experimental group

Treatment:

Other: oral hygiene