Oral Hygiene With Chlorhexidine and Incidence of Ventilator-Associated Pneumonia in Children Submitted to Heart Surgery
Primary Purpose
Ventilator Associated Pneumonia, Nosocomial Pneumonia, Heart Surgery
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
oral hygiene
placebo
Sponsored by
About this trial
This is an interventional prevention trial for Ventilator Associated Pneumonia focused on measuring chlorexidine, ventilator-associated pneumonia, nosocomial pneumonia, heart surgery, oral hygiene
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
1
2
Arm Description
Placebo
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00829842
First Posted
January 26, 2009
Last Updated
January 26, 2009
Sponsor
University of Sao Paulo
1. Study Identification
Unique Protocol Identification Number
NCT00829842
Brief Title
Oral Hygiene With Chlorhexidine and Incidence of Ventilator-Associated Pneumonia in Children Submitted to Heart Surgery
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 Type
Interventional
2. Study Status
Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Sao Paulo
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventilator Associated Pneumonia, Nosocomial Pneumonia, Heart Surgery
Keywords
chlorexidine, ventilator-associated pneumonia, nosocomial pneumonia, heart surgery, oral hygiene
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
160 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Placebo Comparator
Arm Description
Placebo
Arm Title
2
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
oral hygiene
Intervention Description
oral hygiene with 0.12% chlorexidine
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
oral hygiene placebo
10. Eligibility
Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
12. IPD Sharing Statement
Citations:
PubMed Identifier
21558772
Citation
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.
Results Reference
derived
Learn more about this trial
Oral Hygiene With Chlorhexidine and Incidence of Ventilator-Associated Pneumonia in Children Submitted to Heart Surgery
We'll reach out to this number within 24 hrs