Bellissimo‐Rodrigues 2009.
| Methods | Study design: RCT, 2 parallel groups Location: Sao Paulo, Brazil Number of centres: 1 Study period: March 2006 to February 2008 Funding source: Not stated |
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| Participants | Setting: ICU in tertiary care hospital Inclusion criteria: All patients admitted to ICU with expected stay > 48 hours. Not all participants received mechanical ventilation Exclusion criteria: Previous chlorhexidine sensitivity, pregnancy, formal indication for chlorhexidine use, prescription of another oral topical medication Number randomised: 200 (only 133 on ventilators) Number evaluated: 194 Baseline characteristics: ‐ Intervention group: Age: median 62.5 (17 ‐ 89) M/F: 47/51; APACHE II Score: median 17 (5 ‐ 35) ‐ Control group: Age: median 54.0 (15 ‐ 85) M/F: 51/45; APACHE II Score: median 19 (5 ‐ 41) |
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| Interventions |
Comparison: 0.12% chlorhexidine solution versus placebo Experimental group (n = 64 on vent): 0.12% chlorhexidine solution applied orally 3 times daily. Oral hygiene was conducted by nurses specially trained in the protocol. 3 times daily after mechanical cleaning of the mouth by a nurse, 15 ml of study solution was applied and attempts made to distribute solution over all oral surfaces Control group (n = 69 on vent): The same protocol was conducted with the placebo solution, which was identical in colour, consistency, smell and taste |
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| Outcomes | 1. Respiratory tract infections (VAP for those on ventilators) 2. Respiratory tract infection‐free survival time 3. Time from ICU admission to first RTI 4. Duration of mechanical ventilation 5. Length of ICU stay 6. Total mortality 7. Mortality due to RTI 8. Antibiotic use 9. Microbiological culture of endotracheal secretions 10. Adverse effects |
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| Notes | Sample size calculation: "to have sufficient power to detect a 69% difference in incidence of VAP with α = 5% and β = 20% it was estimated that 96 patients per group were required" Only 133/194 of patients evaluated received mechanical ventilation Email sent 3 September 2012. Reply received The Cochrane calculator was used to calculate the SD value for duration of mechanical ventilation, but the SD obtained seemed inappropriate and was therefore not used in data synthesis |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "randomised" Method of sequence generation not described but undertaken by pharmacy |
| Allocation concealment (selection bias) | Low risk | "only the pharmacist knew which code numbers corresponded to which type of solution" |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double blind |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Double blind |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 6/200 participants were excluded from the analysis. 1 control participant needed to receive chlorhexidine treatment, and further 3 in control group and 2 in experimental group were excluded due to protocol violation. Unlikely to have introduced a bias |
| Selective reporting (reporting bias) | Low risk | All planned outcomes reported |
| Other bias | Low risk | No other sources of bias identified |