Munro 2009.
| Methods | Study design: A single‐centre RCT with 4 parallel groups Location: 3 ICUs in large urban University Medical Centre, Virginia, USA Number of centres: 3 (ICUs) Study period: Not stated Funding source: Grant NIH R01 NR07652 |
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| Participants | Inclusion criteria: Critically ill adults (> 18) in 3 intensive care units were enrolled within 24 hours of intubation. All patients older than 18 years (n = 10,913) in medical, surgical/trauma, and neuroscience ICUs were screened for inclusion Exclusion criteria: Clinical diagnosis of pneumonia at the time of intubation, edentulous patients, patients who had a previous endotracheal intubation during the current hospital admission Group 1: 26/18 M/F, age mean 46.1 (18.2) Group 2: 28/21 M/F, age mean 47.1 (15.7) Group 3: 28/20 M/F, age mean 47.3 (18.8) Group 4: 37/14 M/F, age mean 46.8 (16.4) Number randomised: 547 (but 355 subsequently excluded due to pneumonia at baseline) Number evaluated: 192 |
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| Interventions |
Comparison: Chlorhexidine swab versus toothbrushing versus both versus usual care Group 1: (n = 44) a 0.12% solution of chlorhexidine gluconate (chlorhexidine) 5 mL by oral swab twice daily (at 10 AM and 10 PM) Group 2: (n = 49) toothbrushing (manual toothbrush) 3 times a day (at 9 AM, 2 PM, and 8 PM), detailed toothbrushing protocol followed quadrant by quadrant Group 3: (n = 48) combination care (toothbrushing 3 times a day and chlorhexidine every 12 hours) Group 4: (n = 51) control (usual care) |
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| Outcomes | VAP measured by CPIS score, also dichotomised at days 1, 3, 5, 7 Mortality (died during hospitalisation) |
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| Notes | Median length of stay and stay in ICU were presented | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "A randomized controlled 2 × 2 factorial experimental design was used...Patients were randomly assigned to 1 of 4 treatments". "Patients were randomized to treatment within each ICU according to a permuted block design developed by the biostatistician (D.K.M.) before the start of the study" |
| Allocation concealment (selection bias) | Unclear risk | Not mentioned. |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Not possible |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not described |
| Incomplete outcome data (attrition bias) All outcomes | High risk | 355/547 (65%) of those originally randomised were excluded from the analysis at day 3 because they were found to have pneumonia at baseline |
| Selective reporting (reporting bias) | Unclear risk | VAP reported as percentages only and denominator unclear |
| Other bias | Low risk | No other sources of bias identified |