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Oral Care Interventions and Ventilator Associated Pneumonia in Critically Ill Children

Oral Care Interventions With 0.12% Chlorhexidine and Ventilator Associated Pneumonia in Critically Ill Children: Prospective, Randomic and Double Blind Study

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01083407
Enrollment
146
Registered
2010-03-09
Start date
2005-06-30
Completion date
2008-06-30
Last updated
2010-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ventilator Associated Pneumonia

Keywords

Oral care., Chlorhexidine., Pediatric Nursing, Intensive Care, Nosocomial infection, Pneumonia, Oropharyngeal colonization, Tracheal colonization

Brief summary

This experimental study aims to verify the influence of the oral hygiene performance with chlorhexidine digluconate 0.12% in the development of VAP in children. The data collection begun in April, 2005 during the performance of the masters degree course dissertation entitled Clinical study about the effect of the oral hygiene with chlorhexidine digluconate 0.12% in the oropharynx colonization of children in intensive care, being performed in a PICU of nine beds in a university hospital in the city of São Paulo, after approval of the Research Ethics Committee of the institution. The study is composed by three types of variables: Independent variable, dependent variables, and complementary variables. The categorical variables will be analyzed in accordance with the Person's Chi-Square test of or Fisher's exact test. The numerics will be submitted to the analysis of variance ANOVA or Kruskall Wallis. For variables with heterogeneous distribution between the groups, the multivariate analysis will be applied to the evaluation of the influence in the determination of the development risk of the dependent variable. The rejection level will be fixed in 0.05 of the nullity hypothesis.

Detailed description

Recent progress in identification of oral microorganisms has shown that the oropharynx can be a site of origin for dissemination of pathogenic organisms to distant body sites, such as the lungs. THe aims of the study were to compare the oropharyngeal microbiological profile, VAP incidence, duration of mechanical ventilation, and length of stay in the intensive care unit of children receiving mechanical ventilation who had pharmacological or nonpharmacological oral care. A randomized and controlled study has been performed in a pediatric intensive unit in São Paulo, Brazil. The children are randomly assigned to an experimental group that received oral care with use of 0.12% chlorhexidine digluconate or a control group that received oral care without an antiseptic. Oropharyngeal and tracheal secretions were collected and cultured on days 0, 2, and 4, and at discharge.

Interventions

DRUG0.12% Chlorhexidine Digluconate

Oral care with 0.12% Chlorhexidine Digluconate and toothbrushing is realized twice a day and took about 10 minutes to complete, depending on the child's acceptance and clinical conditions.

OTHERToothbrushing

Gel is applied on a toothbrush, and the teeth are cleaned in quadrants; all teeth surfaces are cleaned (vestibular, lingual, occlusal, and incisal). After each quadrant is cleaned, 10 mL of water (dispensed via a syringe) is used to rinse the quadrant and continual aspiration is used to remove all the gel and debris. After all the teeth are cleaned, the ventral surface of the tongue is brushed with posteriorto-anterior movements.

Sponsors

Fundação de Amparo à Pesquisa do Estado de São Paulo
CollaboratorOTHER_GOV
Federal University of São Paulo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
29 Days to 18 Years
Healthy volunteers
No

Inclusion criteria

* Critically ill children. * Age: 29 days to 18 years.

Exclusion criteria

* Newborn age. * Pneumonia at PICU admission. * Tracheostomy. * Tracheal intubation higher than 24 hours in the PICU admission. * PICU LOS lower than 48 hours. * Responsibles declined consent.

Design outcomes

Primary

MeasureTime frameDescription
Ventilator associated pneumonia48 hours after tracheal intubationInfluence of oral care with 0.12% chlorhexidine on VAP incidence diagnosed by clinical pulmonary infection score.

Secondary

MeasureTime frameDescription
PICU Lengh of StayNecessary days to PICU dischargeInfluence of oral care with 0.12% chlorhexidine on PICU LOS
Time of Mechanical pulmonary ventilationLast day of MPVInfluence of oral care with 0.12% chlorhexidine on time of mechanical ventilation.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026