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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00829842
First Posted: January 27, 2009
Last Update Posted: January 27, 2009
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.
Information provided by:
University of Sao Paulo
  Purpose
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 Intervention Phase
Ventilator Associated Pneumonia Nosocomial Pneumonia Heart Surgery Other: oral hygiene Other: placebo Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Enrollment: 160
Study Start Date: February 2006
Study Completion Date: February 2006
Arms Assigned Interventions
Placebo Comparator: 1
Placebo
Other: placebo
oral hygiene placebo
Experimental: 2 Other: oral hygiene
oral hygiene with 0.12% chlorexidine

  Eligibility

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
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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00829842     History of Changes
Other Study ID Numbers: HCRP 8904/2005
First Submitted: January 26, 2009
First Posted: January 27, 2009
Last Update Posted: January 27, 2009
Last Verified: January 2009

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

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