Oral Care Interventions and Ventilator Associated Pneumonia in Critically Ill Children
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Ventilator Associated Pneumonia |
Drug: 0.12% Chlorhexidine Digluconate Other: Toothbrushing |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Prevention |
| Official Title: | Oral Care Interventions With 0.12% Chlorhexidine and Ventilator Associated Pneumonia in Critically Ill Children: Prospective, Randomic and Double Blind Study |
- Ventilator associated pneumonia [ Time Frame: 48 hours after tracheal intubation ] [ Designated as safety issue: No ]Influence of oral care with 0.12% chlorhexidine on VAP incidence diagnosed by clinical pulmonary infection score.
- PICU Lengh of Stay [ Time Frame: Necessary days to PICU discharge ] [ Designated as safety issue: No ]Influence of oral care with 0.12% chlorhexidine on PICU LOS
- Time of Mechanical pulmonary ventilation [ Time Frame: Last day of MPV ] [ Designated as safety issue: No ]Influence of oral care with 0.12% chlorhexidine on time of mechanical ventilation.
| Enrollment: | 146 |
| Study Start Date: | June 2005 |
| Study Completion Date: | June 2008 |
| Primary Completion Date: | June 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 0.12% Chlorhexidie Digluconate
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.
|
Drug: 0.12% 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.
|
|
Placebo Comparator: Toothbrushing
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.
|
Other: Toothbrushing
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.
|
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.
Eligibility| Ages Eligible for Study: | up to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts 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.
Contacts and Locations More Information
No publications provided by Federal University of São Paulo
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Federal University of São Paulo, Nursing Department |
| ClinicalTrials.gov Identifier: | NCT01083407 History of Changes |
| Other Study ID Numbers: | Oral care and VAP in children. |
| Study First Received: | March 5, 2010 |
| Last Updated: | March 8, 2010 |
| Health Authority: | Brazil: Ethics Committee |
Keywords provided by Federal University of São Paulo:
|
Oral care. Chlorhexidine. Pediatric Nursing Intensive Care |
Nosocomial infection Pneumonia Oropharyngeal colonization Tracheal colonization |
Additional relevant MeSH terms:
|
Critical Illness Pneumonia Pneumonia, Ventilator-Associated Disease Attributes Pathologic Processes 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 May 22, 2013