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Oral Care Interventions and Ventilator Associated Pneumonia in Critically Ill Children

Primary Purpose

Ventilator Associated Pneumonia

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
0.12% Chlorhexidine Digluconate
Toothbrushing
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Ventilator Associated Pneumonia focused on measuring Oral care., Chlorhexidine., Pediatric Nursing, Intensive Care, Nosocomial infection, Pneumonia, Oropharyngeal colonization, Tracheal colonization

Eligibility Criteria

29 Days - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    0.12% Chlorhexidie Digluconate

    Toothbrushing

    Arm Description

    Oral care included use of an oral gel containing chlorhexidine digluconate 0.12% as an active ingredient (chlorhexidine digluconate 0.12%; methylcellulose gel 2.12%, 25 g; gooseberry syrup, 4 drops; menthol solution 50%,3 drops; and distilled water, to 30 g).The 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 was 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.

    This group received the same oral care that experimental group with the use of a similarly formulated gel without the antiseptic agent.The 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.

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    PICU Lengh of Stay
    Influence of oral care with 0.12% chlorhexidine on PICU LOS
    Time of Mechanical pulmonary ventilation
    Influence of oral care with 0.12% chlorhexidine on time of mechanical ventilation.

    Full Information

    First Posted
    March 5, 2010
    Last Updated
    March 8, 2010
    Sponsor
    Federal University of São Paulo
    Collaborators
    Fundação de Amparo à Pesquisa do Estado de São Paulo
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01083407
    Brief Title
    Oral Care Interventions and Ventilator Associated Pneumonia in Critically Ill Children
    Official Title
    Oral Care Interventions With 0.12% Chlorhexidine and Ventilator Associated Pneumonia in Critically Ill Children: Prospective, Randomic and Double Blind Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2005 (undefined)
    Primary Completion Date
    June 2006 (Actual)
    Study Completion Date
    June 2008 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Federal University of São Paulo
    Collaborators
    Fundação de Amparo à Pesquisa do Estado de São Paulo

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ventilator Associated Pneumonia
    Keywords
    Oral care., Chlorhexidine., Pediatric Nursing, Intensive Care, Nosocomial infection, Pneumonia, Oropharyngeal colonization, Tracheal colonization

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    146 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    0.12% Chlorhexidie Digluconate
    Arm Type
    Experimental
    Arm Description
    Oral care included use of an oral gel containing chlorhexidine digluconate 0.12% as an active ingredient (chlorhexidine digluconate 0.12%; methylcellulose gel 2.12%, 25 g; gooseberry syrup, 4 drops; menthol solution 50%,3 drops; and distilled water, to 30 g).The 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 was 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.
    Arm Title
    Toothbrushing
    Arm Type
    Placebo Comparator
    Arm Description
    This group received the same oral care that experimental group with the use of a similarly formulated gel without the antiseptic agent.The 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.
    Intervention Type
    Drug
    Intervention Name(s)
    0.12% Chlorhexidine Digluconate
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Toothbrushing
    Intervention Description
    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 Outcome Measure Information:
    Title
    Ventilator associated pneumonia
    Description
    Influence of oral care with 0.12% chlorhexidine on VAP incidence diagnosed by clinical pulmonary infection score.
    Time Frame
    48 hours after tracheal intubation
    Secondary Outcome Measure Information:
    Title
    PICU Lengh of Stay
    Description
    Influence of oral care with 0.12% chlorhexidine on PICU LOS
    Time Frame
    Necessary days to PICU discharge
    Title
    Time of Mechanical pulmonary ventilation
    Description
    Influence of oral care with 0.12% chlorhexidine on time of mechanical ventilation.
    Time Frame
    Last day of MPV

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    29 Days
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    22497915
    Citation
    Kusahara DM, Friedlander LT, Peterlini MA, Pedreira ML. Oral care and oropharyngeal and tracheal colonization by Gram-negative pathogens in children. Nurs Crit Care. 2012 May-Jun;17(3):115-22. doi: 10.1111/j.1478-5153.2012.00494.x. Epub 2012 Feb 23.
    Results Reference
    derived

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    Oral Care Interventions and Ventilator Associated Pneumonia in Critically Ill Children

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