Oral Care Interventions and Ventilator Associated Pneumonia in Critically Ill Children

NCT01083407 | Completed Phase 1

• 1 other identifier: Oral care and VAP in children.
• Study Type: interventional
• Target: 146
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Ventilator Associated Pneumonia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Ventilator associated pneumonia

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

  48 hours after tracheal intubation

Secondary Outcomes (2)

• PICU Lengh of Stay

  Necessary days to PICU discharge

• Time of Mechanical pulmonary ventilation

  Last day of MPV

Study Arms (2)

0.12% Chlorhexidie Digluconate

EXPERIMENTAL

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

Toothbrushing

PLACEBO COMPARATOR

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

Interventions

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.

0.12% Chlorhexidie Digluconate

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.

Toothbrushing

Eligibility Criteria

• Age: 29 Days - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of São Paulo: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Related Publications (1)

• 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.

  PMID: 22497915 DERIVED

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated; Cross Infection; Pneumonia

Interventions

chlorhexidine gluconate; Toothbrushing

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Oral Hygiene; Preventive Dentistry; Dentistry

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 5, 2010
• First Posted: March 9, 2010
• Study Start: June 1, 2005
• Primary Completion: June 1, 2006
• Study Completion: June 1, 2008
• Last Updated: March 9, 2010

Record last verified: 2009-03