Bopp 2006.
| Methods | Study design: Pilot study, 2‐arm RCT Location: USA Number of centres: 1 Study period: February 2002 to August 2002 Funding source: Grant from American Dental Hygienists' Association's Institute for Oral Health |
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| Participants | Setting: Critical care unit Inclusion criteria: Orally and nasally intubated patients entering critical care unit Exclusion criteria: Taking metronidazole, history of allergy to chlorhexidine, sensitive to alcohol, risk for endocarditis, history of other serious illness (specified), those with pneumonia Number randomised: 5 Number evaluated: 5 Baseline characteristics: ‐ Intervention group: Age: 40, range 28 ‐ 52; M/F: 0/2 ‐ Control group: Age: 73.7, range 62 ‐ 81; M/F: 2/1 |
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| Interventions |
Comparison: 0.12% chlorhexidine + suction toothbrush versus suction swab + hydrogen peroxide Experimental group (n = 2): Twice daily oral hygiene care with 0.12% chlorhexidine gluconate during intubation period plus oral cleaning with PlaqVac suction toothbrush Control group (n = 3): Standard oral care 6 times daily using a suctioning soft foam swab and half‐strength hydrogen peroxide, plus oral lubricant |
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| Outcomes | Microbial colonisation VAP, mortality | |
| Notes | Sample size calculation: This was a pilot study. Data were not used in meta‐analysis on advice of statistician Email sent to contact author 14 November 2012, reply received 19 November 2012 |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "...randomly assigned to either control or experimental treatment by the flip of a coin" |
| Allocation concealment (selection bias) | High risk | Coin toss was undertaken by researcher. No allocation concealment |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Blinding not possible. Reply from contact author "they were not blinded" |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Reply from contact author "they were not blinded" |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | All randomised participants included in outcome evaluation |
| Selective reporting (reporting bias) | Unclear risk | VAP planned and reported in this pilot study. Microbial culture data not reported per person, and mortality is also reported |
| Other bias | Low risk | No other sources of bias detected |