Kusahara 2012a.
| Methods | Study design: Double‐blind placebo‐controlled RCT Location: Sao Paulo, Brazil Number of centres: 1, tertiary care hospital affiliated with Federal University of Sao Paulo Brazil Study period: 36 months dates not stated Funding source: Funded by a grant from Fundacao de Amparo a Pesquisa do Estado de Sao Paulo (04‐13361‐2) |
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| Participants | Setting: PICU Inclusion criteria: Children admitted to PICU likely to require ventilation within 24 hours of admission Exclusion criteria: Newborn, confirmed diagnosis of pneumonia at admission, known hypersensitivity to chlorhexidine, tracheostomy, duration of ventilation < 48 hours, intubated for > 24 hours prior to PICU admission Number randomised: 96 (46/50) Number evaluated: 96, at day 2 (44/45), at day 4 23/23 Baseline characteristics: ‐ Intervention group: Age: 12 ± 49.75 months; M/F: 28/18 ‐ Control group: Age: 34.5 ± 58.8 months; M/F: 32/18 |
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| Interventions |
Toothbrushing + 0.12% chlorhexidine gel versus toothbrushing + placebo Experimental group: Oral care with toothbrushing and oral gel containing chlorhexidine twice daily (08:00 & 20:00 hours). Mouth was divided into 4 quadrants and each brushed in a defined pattern. With child in lateral position, gel was applied directly to toothbrush, and all tooth surfaces (vestibular, lingual, occlusal and incisal) were cleaned and ventral surface of tongue was brushed posterior to anterior. Each quadrant was rinsed with water and excess fluid and debris were removed with continuous suction. Finally oral foam applicator was immersed in the gel and applied all over the gingival surfaces of the participant Control group: Oral care with toothbrushing and placebo oral gel twice daily. With child in lateral position, gel was applied directly to toothbrush, and all tooth surfaces (vestibular, lingual, occlusal and incisal) were cleaned and ventral surface of tongue was brushed posterior to anterior. Each quadrant was rinsed with water and excess fluid and debris were removed with continual suction. Finally oral foam applicator was immersed in the gel and applied all over the gingival surfaces of the participant |
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| Outcomes | 1. Incidence of VAP 2. Duration of ventilation in PICU 3. Length of stay in PICU 4. Hospital mortality 5. Tracheal colonisation with Gram +ve & ‐ve organisms |
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| Notes | Sample size calculation: Reported that this was not done "due to the absence of previous research on this population" Email correspondence with Prof Pedreira confirmed that Pedreira 2009 and Kusahara 2012a both refer to the same study. NCT 01083407 & NCT0410682 at ClinicalTrials.gov |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "..randomised into two groups using a balanced randomisation table generated by True Epistat Program" |
| Allocation concealment (selection bias) | Low risk | Both chlorhexidine and identical placebo gels were supplied by pharmacy in identical containers and only the pharmacist was aware of the gel type for each participant |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double blind. Identical placebo used so that neither participants nor clinical staff were aware of allocated treatment |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Double blind. Only the pharmacist was aware of the gel type for each participant |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | All randomised participants included in the outcome evaluation |
| Selective reporting (reporting bias) | Low risk | One primary and 4 secondary outcomes reported in full |
| Other bias | Unclear risk | Statistically significant difference in mean age of children in each group. This may have introduced a bias |