Ozcaka 2012.
| Methods | Study design: double‐blind placebo‐controlled RCT Location: Izmir, Turkey Number of centres: 1 Study period: November 2007 to November 2009 Funding source: "The study was funded solely by the institutions of the authors" |
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| Participants | Setting: respiratory ICU Inclusion criteria: patients aged 18 or over, admitted to respiratory ICU expecting to require ventilation for > 48 hours Exclusion criteria: witnessed episode of aspiration, confirmed diagnosis of post‐obstructive pneumonia, known hypersensitivity to chlorhexidine, diagnosed thrombocytopenia, pregnancy, oral mucositis, readmission to same ICU, expected survival < 1 week, edentulism Number randomised: 66 Number evaluated: 61 Baseline characteristics: ‐ Intervention group: age: 60.5 ± 14.7 years ‐ Control group: age: 56.0 ± 18.2 years |
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| Interventions |
Comparison: Chlorhexidine solution versus saline Experimental group (n = 32): oral mucosa was swabbed with 0.2% chlorhexidine on sponge pellets, 4 times daily. Excess rinse was suctioned from patient's mouth after 1 minute Control group (n = 34): oral mucosa was swabbed with saline on sponge pellets, 4 times daily. Excess rinse was suctioned from patient's mouth after 1 minute Deep suctioning was performed in both groups every 6 hours and following position changes to remove pooled secretions from around the cuff of the endotracheal tube |
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| Outcomes | 1. Incidence of VAP 2. Mortality 3. Duration of ventilation in ICU 4. Length of stay in ICU 5. Presence of potential respiratory pathogens in minibronchoalveolar lavage |
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| Notes | Sample size calculation: Estimated that 28 participants would be required in each group to give 81% power with α of 5%, to show a reduction in VAP from 70% to 30% Email sent 22 January 2013 and reply received 29 January 2013 |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "The randomisation prepared a set of subject identification (SID) numbers which had assigned treatment" Description unclear, but involvement of statistician suggests this was well done |
| Allocation concealment (selection bias) | Low risk | "Study nurse obtained the SID number when the patient was enrolled" Allocation was probably concealed and not able to be anticipated by investigators |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | "Assignment of treatment was blinded to patients and to all investigators, including periodontist, .... respiratory ICU physicians and outcome statisticians" |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | "Assignment of treatment was blinded to patients and to all investigators, including periodontist, .... respiratory ICU physicians and outcome statisticians" |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 66 participants randomised, 1 secondary exclusion from each group, and 2 and 1 early deaths in chlorhexidine and control groups, respectively. Unlikely to have introduced a bias |
| Selective reporting (reporting bias) | Low risk | Planned outcomes reported |
| Other bias | Low risk | No other sources of bias identified |