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Completed

NCT Number: NCT01083407

Oral Care Interventions and Ventilator Associated Pneumonia in Critically Ill Children

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.

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Key information

Conditions

Ventilator Associated Pneumonia Cross Infection Disease Attributes Healthcare-Associated Pneumonia Iatrogenic Disease Infections Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Ventilator-Associated Respiratory Tract Diseases Respiratory Tract Infections

Age range

29 day–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

0.12% Chlorhexidine Digluconate

Drug

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.

Toothbrushing

Other

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.

Primary outcomes

  1. Ventilator associated pneumonia

    Time frame: 48 hours after tracheal intubation

    Influence of oral care with 0.12% chlorhexidine on VAP incidence diagnosed by clinical pulmonary infection score.

Secondary outcomes

  1. PICU Lengh of Stay

    Time frame: Necessary days to PICU discharge

    Influence of oral care with 0.12% chlorhexidine on PICU LOS

  2. Time of Mechanical pulmonary ventilation

    Time frame: Last day of MPV

    Influence of oral care with 0.12% chlorhexidine on time of mechanical ventilation.

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2006
Study completion
2008
First posted
Mar 9, 2010
Registry last updated
Mar 9, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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