Chen 2008.
| Methods | Study design: A single‐centre RCT with 2 parallel groups Location: China Number of centres: 1 surgical ICU in provincial hospital Study period: Not stated Funding source: External |
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| Participants | Inclusion criteria: Admission into the ICU, orally intubated, receiving mechanical ventilation ≥ 7 days, without oral and lung disease Exclusion criteria: Using hormone therapy; with diabetes Number randomised: 120 Number evaluated: 120 ‐ Intervention group: n = 60; mean age: 42.0 ± 9.0; M/F: 39/21 ‐ Control group: n = 60; mean age: 40.0 ± 8.0; M/F: 45/15 Baseline characteristics were comparable |
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| Interventions |
Comparison: Oral care + chlorhexidine rinse versus saline rinse Intervention group: Oral cavity irrigated with 50 ml GSE rinse (chlorhexidine + extracts of grapefruit + FE enzyme) then aspirated off, 4 times a day, and routine oral nursing care was given once a day after the first irrigation Control group: Oral irrigation with 50 ml saline, 4 times a day, without the combination of routine oral care |
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| Outcomes | 3 outcome variables were reported: 1. Incidence of VAP after 7 days of mechanical ventilation 2. Incidence of oral inflammation (ulceration and herpes) 3. Change in bacteria colonisation: the throat swab cultures at baseline and after treatment |
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| Notes | GSE rinse: We are advised by reviewers from China that GSE rinse should be treated as chlorhexidine + 2 potentially active other antiseptics Diagnosis of VAP was according to Chinese Society of Respiratory Diseases criteria Information translated from Chinese paper by Shi Zongdao and colleagues |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Patients were randomised into different groups according to a randomised number table |
| Allocation concealment (selection bias) | Unclear risk | Not mentioned |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Blinding not described and not possible. Difference between intervention and control means caregivers would be aware of who was in each group |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Blinding not described |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No withdrawals |
| Selective reporting (reporting bias) | Unclear risk | Insufficient information on throat swab culture result (baseline and after treatment) |
| Other bias | Unclear risk | The treatment group received co‐intervention of routine oral nursing care once daily, but this was not done in the control group |