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

Phase 3

Completed

• Conditions: Ventilator Associated Pneumonia; Nosocomial Pneumonia; Heart Surgery
• Interventions: Other: placebo; Other: oral hygiene

• Registration Number: NCT00829842
• Lead Sponsor: University of Sao Paulo

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-02
• Study Completion: 2006-02
• Status Verified: 2009-01
• Study First Submitted: 2009-01-26
• Study First Submitted QC: 2009-01-26
• Last Update Submitted: 2009-01-26
• Study First Posted: 2009-01-27
• Last Update Posted: 2009-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	placebo	Placebo
2	oral hygiene	-