Hu 2009.
Study characteristics | ||
Methods | Study design: RCT Location: Beijing, China Number of centres: 1 Study period: Not stated Funding source: No external funding |
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Participants | Setting: ICU in second affiliated hospital of PLA General Hospital Inclusion criteria: Patients in ICU receiving mechanical ventilation Exclusion criteria: Unclear Number randomised: 47 Number evaluated: Unclear Baseline characteristics: Not reported for each randomised group in total Those with 48/72 hour data: ‐ Experimental group: n = 25, M/F 16/9, age range 19 ‐ 68 ‐ Control group: n = 22, M/F 13/9, age range 22 ‐ 60 |
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Interventions |
Comparison: Saline swab + rinse versus saline swab Experimental group: Lips, teeth, tongue and palate were swabbed with a saline saturated cotton ball and the oral cavity was rinsed with saline twice daily. Control group: Lips, teeth, tongue and palate were swabbed with saline saturated cotton ball twice daily. |
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Outcomes | VAP, mortality, days on ventilator, days in hospital, halitosis, ulceration | |
Notes | Information translated from Chinese paper by Shi Zongdao and colleagues. Unable to confirm outcome data with trial authors | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Email from author "the sequence was generated by using a random number table". |
Allocation concealment (selection bias) | Low risk | Email from author "allocation was concealed using opaque envelopes numbered with inclusion sequence". |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants and caregivers were not blinded to interventions received. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Email from author "the outcome assessors were a group of nurses not involved with the interventions". Probably blinded to allocated treatment group. |
Incomplete outcome data (attrition bias) All outcomes | High risk | The number of participants included in the outcome assessments at each time point was unclear. VAP reported as percentages only |
Selective reporting (reporting bias) | High risk | All planned outcomes reported but as percentages only |
Other bias | Low risk | No other sources of bias identified |