Long 2012.
| Methods | Study design: A single‐centre RCT with 2 parallel groups Location: China Number of centres: 1 ICU in the university hospital Study period: February 2010 to March 2012 Funding source: Program for masters degree |
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| Participants | Inclusion criteria: Patients admitted to ICU, with oral intubation, receiving mechanical ventilation ≥ 48 hours, age ≥ 18 years, patients or their relatives agreed to participate in the study Exclusion criteria: Intubated in emergency e.g. after cardiac arrest, operations upon the oral cavity, trauma of the respiratory tract, with severe bleeding or coagulation disorders Number randomised: 70 Number evaluated: 61 (the other 9 were death or ventilation < 48 hours) ‐ Intervention group: Mean age: 60.06 ± 10.71 years, M/F 20/11, APACHE 17.94 ± 1.24 ‐ Control group: Mean age: 63.67 ± 10.02 years, M/F 18/12, APACHE 18.23 ± 0.57 |
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| Interventions |
Comparison: Povidone iodine + toothbrushing versus povidone iodine alone Experimental group (n = 31): Modified oral nursing method: swab with 0.1% povidone iodine immediately before intubation, then toothbrushing and rinsing with 0.1 povidone iodine, 3 times a day Control group (n = 30): Usual oral nursing method: swab with cotton balls soaked with 0.1% povidone iodine |
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| Outcomes | 3 outcome variables were available: 1. Incidence of VAP 2. Mortality 3. Ventilation days |
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| Notes | Microbial examinations for the aspirate secretions obtained from inferior respiratory tract every day after intubation were referred for diagnosis of VAP | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "...patients were randomly assigned into 2 groups, observing group and control group with 35 cases in each group" |
| Allocation concealment (selection bias) | Unclear risk | Not specified |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Blinding not described and not possible for the caregivers who would be aware of who was in each group |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not specified |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 9 randomised participants were excluded from analysis, numbers and reasons similar for each group |
| Selective reporting (reporting bias) | Low risk | Planned outcomes reported |
| Other bias | Unclear risk | Only the results of microbial examination of the aspirate secretions from the inferior respiratory tract as tool of VAP diagnosis may not be enough |