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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00829842
Recruitment Status : Completed
First Posted : January 27, 2009
Last Update Posted : January 27, 2009
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Ventilator Associated Pneumonia Nosocomial Pneumonia Heart Surgery Other: oral hygiene Other: placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Evaluation of Oral Hygiene With 0.12% Chlorhexidine Antiseptic Solution on the Incidence of Nosocomial Pneumonia and Ventilator-Associated Pneumonia in Children Submitted to Heart Surgery
Study Start Date : February 2006
Actual Study Completion Date : February 2006

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: 1
Other: placebo
oral hygiene placebo

Experimental: 2 Other: oral hygiene
oral hygiene with 0.12% chlorexidine

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00829842     History of Changes
Other Study ID Numbers: HCRP 8904/2005
First Posted: January 27, 2009    Key Record Dates
Last Update Posted: January 27, 2009
Last Verified: January 2009

Keywords provided by University of Sao Paulo:
ventilator-associated pneumonia
nosocomial pneumonia
heart surgery
oral hygiene

Additional relevant MeSH terms:
Pneumonia, Ventilator-Associated
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Cross Infection
Ventilator-Induced Lung Injury
Lung Injury
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Dermatologic Agents