Reducing the Incidence of VAP in Critically Ill Children and Assessment of Oral Care With CHX
Condition: Ventilator Associated Pneumonia
MeSH terms: Pneumonia; Pneumonia, Ventilator-Associated
Study type: Interventional

Summary: 
      This was a single-centered, randomized, placebo-controlled double-blind clinical trial
      conducted in the pediatric intensive care unit (PICU), in patients who were aged 1 month to
      18 years, needing MV for at least 48 hours, to evaluate the effect of Chlorhexidine (CHX) on
      Ventilator-associated pneumonia (VAP) incidence and to determine VAP risk factors.
    

Detailed description: 
      Patients were randomized into two groups receiving CHX (0.12%) or placebo (0.9% NaCl) and
      followed for VAP development. All patients were consecutively randomized (1:1) to receive
      either 0.12% CHX rinse solution or placebo applications using a computer generated balanced
      randomization table. The unlabeled standardized tubes containing placebo or 0.12% CHX were
      serially numbered and bagged for each patient according to randomization. The preparation of
      bagged treatments and their numbering were done by the same personnel who was not involved in
      the study. The placebo rinse contained 0.9% NaCl (normal saline [NS]), and was identical to
      the 0.12% CHX rinse solution with regard to appearance, consistency, taste and smell. The
      patients, physicians, outcome assessors, and data analysts were kept blinded to the
      intervention.

      The standard care protocols in the PICU were performed. Before beginning the study, nurses
      received a training program for VAP prevention, procedure/technique for oral hygiene and use
      of oral mucosa assessment score under supervision of pediatric residents. They were trained
      on the method of application of solutions according to CDC guidelines in order to ensure
      uniform treatments. Nurses were double blinded and had no knowledge of the solution they were
      using.

      Both treatment groups (placebo and 0.12% CHX) received treatments at 4-hour intervals, nurses
      used the whole content of 5 ml tubes containing rinse solution. In both groups, nurses
      performed oral cleansing as follows: first, the endotracheal cuff pressure was tested to
      ensure proper pressure prior to oral care and oropharyngeal secretions were aspirated to
      remove any accumulated secretions. Then the application of rinse solutions to cleanse all
      areas of the oral cavity, including the anterior and posterior pharynx, gums, teeth, tongue,
      and buccal mucosa, with standard disposable applicator (foam swab) was applied, followed by
      removal of excess solution from the mouth by a sterile catheter. Strict hand hygiene was
      ensured during the procedures. The period of application was from the day of intubation until
      extubation. Presence of any adverse effect of the solutions was recorded. Beck oral
      assessment score (BOAS) was used twice daily to evaluate the oral health of both groups.
    

Intervention name(s): Oral care with 0,12% Chlorhexidine
Intervention type(s): Other
Intervention description(s): 0, 12 % CHX, and standard oral care with 0,9% NaCl were compared to assess VAP rates. Both solutions were applied to critically ill children who were intubated.
Intervention MeSH terms: Chlorhexidine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: All patients were consecutively randomized (1:1) to receive either 0.12% CHX rinse solution or placebo applications using a computer generated balanced randomization table.
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
Keywords: Oral care; Chlorhexidine; ventilator associated pneumonia