Yao 2011.
| Methods | Study design: Single‐blind pilot RCT (NCT 00604916) Location: Taiwan Number of centres: 1 Study period: March to November 2007 Funding source: Grants from Taiwan National Science Council and career development grant from National Health Research Institutes |
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| Participants | Setting: Surgical ICU Inclusion criteria: Intubated and ventilated postoperative patients expected to be in ICU > 48 hours and expected to require mechanical ventilation for 48 ‐ 72 hours with nasal or endotracheal intubation Exclusion criteria: Patients with pneumonia at baseline Number randomised: 53 Number evaluated: 53 (VAP), day 3 ‐ 4 50, day 7 ‐ 8 42 Baseline characteristics: ‐ Intervention group: Age: 60.7 ± 16.0; M/F: 17/11; APACHE II Score: 19.6 ± 5.2 ‐ Control group: Age: 60.5 ± 16.5; M/F: 17/8; APACHE II Score: 19.4 ± 4.4 |
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| Interventions |
Comparison: Oral care + toothbrushing twice a day versus usual oral care Experimental group: Standardised oral care protocol twice daily for 15 ‐ 20 minutes for 7 days from trained intervention nurse. Bed elevated 30° to 45°, hypopharyngeal suctioning, mouth moistened with 5 ‐ 10 ml purified water, buccal surfaces of teeth cleaned with powered toothbrush and lingual tooth surfaces and tongue, gums and mucosa massaged with soft paediatric toothbrush. Oral cavity then cleaned with toothette swab connected to a suction tube and rinsed with 50 ml water + hypopharyngeal suctioning Control group: Received oral care protocol, twice daily for 10 ‐ 15 minutes provided by same trained intervention nurse. Participants elevated, hypopharyngeal suctioning, lips moistened with toothette swab and water, then further hypopharyngeal suctioning |
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| Outcomes | 1. Oral Assessment Guide (OAG) score 2. Plaque score (Turesky‐Gilmore‐Glickman modification of Quigley‐Hein plaque index with disclosing dye. Recorded 1 tooth from each quadrant (prioritising premolars and incisors) scores summed) 3. Duration of ventilation 4. Length of ICU stay 5. Incidence of VAP (defined as CPIS > 6) 4. Mortality (ICU) |
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| Notes | Sample size calculation: Pilot study NCT 00604916 at ClinicalTrials.gov Email sent to author 14 November 2012. Reply received 12 December 2012 |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "...randomized using a computer generated randomization table" |
| Allocation concealment (selection bias) | Unclear risk | Not mentioned in trial report Unclear whether allocation was concealed from researchers prior to assignment |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Experimental group received toothbrushing (both powered and manual) and control group did not, so blinding of participants and personnel not possible |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Outcomes assessed blinded to allocated treatment. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | VAP outcome assessed in all randomised participants. For oral health and plaque outcomes 8/28 (experimental) and 7/25 (control) participants lost (transferred to ward) and 2/28 participants in experimental group died |
| Selective reporting (reporting bias) | Low risk | Planned outcomes reported, but denominators unclear for VAP and mortality. However this information was supplied by email from the authors |
| Other bias | Unclear risk | 3/28 (11%) and 1/25 (4%) participants in experimental and control groups were edentulous. Unclear how the intervention and outcomes were applied in these participants |