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

NCT ID: NCT00829842

Last Updated: 2009-01-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-02-28
• Study Completion Date: 2006-02-28

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.

Conditions

Ventilator Associated Pneumonia; Nosocomial Pneumonia; Heart Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

1

Placebo

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: OTHER

oral hygiene placebo

2

Group Type: EXPERIMENTAL

oral hygiene

Intervention Type: OTHER

oral hygiene with 0.12% chlorexidine

Interventions

oral hygiene

oral hygiene with 0.12% chlorexidine

Intervention Type: OTHER

placebo

oral hygiene placebo

Intervention Type: OTHER

Eligibility Criteria

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

• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo

OTHER

Sponsor Role: lead

References

Jacomo AD, Carmona F, Matsuno AK, Manso PH, Carlotti AP. Effect of oral hygiene with 0.12% chlorhexidine gluconate on the incidence of nosocomial pneumonia in children undergoing cardiac surgery. Infect Control Hosp Epidemiol. 2011 Jun;32(6):591-6. doi: 10.1086/660018.

Reference Type: DERIVED

PMID: 21558772 (View on PubMed)

Other Identifiers

HCRP 8904/2005

Identifier Type: -

Identifier Source: org_study_id