Meinberg 2012.
| Methods | Study design: Parallel‐group RCT Location: Brazil Number of centres: 1 Study period: July 2007 to December 2009 Funding source: Not stated |
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| Participants | Setting: surgical ICU Inclusion criteria: > 18 years, receiving mechanical ventilation within 24 hours of admission, expected to require ventilation for > 72 hours. Exclusion criteria: Aspiration pneumonia, tracheostomy, pregnancy and immunosuppression Number randomised: 52 (28/24) Number evaluated: 52 (28/24) Baseline characteristics: ‐ Intervention group: Age: 40.1 ± 14.6 years; APACHE II 17.9 ± 4.5 ‐ Control group: Age: 41.0 ± 19.0 years; APACHE II 16.7 ± 6.8 |
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| Interventions |
Comparison: Toothbrushing + 2% chlorhexidine gel versus toothbrushing + placebo gel Experimental group (n = 28): Toothbrushing plus chlorhexidine gel 2% 4 times daily Control group (n = 24): Toothbrushing plus placebo gel 4 times daily |
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| Outcomes | 1. VAP 2. Mortality 2. ICU mortality 3. Duration of intubation 4. Duration of ICU stay 5. Duration of hospital stay |
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| Notes | Errors in numbers reported for duration of intubation in Table 2 | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | This was undertaken by the pharmacist |
| Allocation concealment (selection bias) | Low risk | "only the pharmacist responsible for preparing the solutions and for the randomisation process knew the contents of the distributed gel tubes" |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | "only the pharmacist responsible for preparing the solutions and for the randomisation process knew the contents of the distributed gel tubes" "placebo group (gel with same colour and consistency)" |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | "only the pharmacist responsible for preparing the solutions and for the randomisation process knew the contents of the distributed gel tubes" |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No dropouts |
| Selective reporting (reporting bias) | High risk | Adverse events not reported. Data not fully reported. Data errors |
| Other bias | High risk | Study terminated due to 'futility'. Reason for termination unclear |