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

Sponsor:	University of Sao Paulo
Information provided by:	University of Sao Paulo
ClinicalTrials.gov Identifier:	NCT00829842

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 III

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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:

MedlinePlus related topics: Dental Health Heart Surgery Pneumonia

Drug Information available for: Chlorhexidine Chlorhexidine digluconate Hibiclens

U.S. FDA Resources

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

Ages Eligible for Study:	up to 18 Years
Genders Eligible for Study:	Both
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

No publications provided by University of Sao Paulo

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Jácomo 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.

ClinicalTrials.gov Identifier:	NCT00829842 History of Changes
Other Study ID Numbers:	HCRP 8904/2005
Study First Received:	January 26, 2009
Last Updated:	January 26, 2009
Health Authority:	Brazil: Ministry of Health; Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo:

chlorexidine
ventilator-associated pneumonia
nosocomial pneumonia
heart surgery
oral hygiene

Additional relevant MeSH terms:

Pneumonia
Pneumonia, Ventilator-Associated
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
Therapeutic Uses
Pharmacologic Actions
Disinfectants
Dermatologic Agents

ClinicalTrials.gov processed this record on February 09, 2012