Lorente 2012.
Methods | Study design: Parallel‐group RCT Location: Tenerife, Spain Number of centres: 1 Study period: August 2010 to August 2011 Funding source: Hospital funding |
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Participants | Setting: Medical/surgical ICU Inclusion criteria: Consecutive patients undergoing invasive mechanical ventilation for at least 24 hours Exclusion criteria: Edentulous, aged < 18 years, pregnant, HIV positive, white blood cells < 1000 cells/mm3, solid or haematological tumour, immunosuppressive therapy, mechanical ventilation duration < 24 hours Number randomised: 436 (217/219) Number evaluated: 436 Baseline characteristics: ‐ Intervention group: Age: 61.0 ± 15.6 years; M/F: 146/71 ‐ Control group: Age: 60.4 ± 16.6 years; M/F: 145/74 |
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Interventions |
Toothbrushing + 0.12% chlorhexidine gel versus chlorhexidine alone Experimental group (n = 217): Oral cleansing performed with 0.12% chlorhexidine impregnated gauze, and oral cavity injection, followed by manual brushing of the teeth with a brush impregnated with 0.12% chlorhexidine (tooth by tooth on the anterior and posterior surfaces, the gum line and the tongue for a period of 90 seconds) Control group (n = 219): Oral cleansing performed with 0.12% chlorhexidine impregnated gauze, and oral cavity injection only In both groups nurse performed oral care every 8 hours. First endotracheal cuff pressure was tested, oropharyngeal secretions were aspirated, then chlorhexidine impregnated gauze was used to cleanse the teeth, tongue and mucosal surfaces, followed by injection of 10 ml 0.12% of chlorhexidine digluconate into oral cavity, and finally after 30 seconds the OParea was suctioned |
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Outcomes | 1. Incidence of VAP 2. Duration of ventilation 3. ICU mortality 4. Tracheal colonisation with Gram +ve & ‐ve organisms 5. Antibiotic exposure |
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Notes | Sample size calculation: Estimated that 218 participants required in each group to give 80% power and α error of 5%, to show a reduction in VAP from 15% to 7.5% | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "..a list of random numbers generated with Excel software (Microsoft, Seattle, WA)" |
Allocation concealment (selection bias) | Unclear risk | No information about allocation concealment |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Not possible |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | "The diagnosis of VAP was made by an expert panel, blinded to group assignment" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All randomised participants are included in the outcome evaluations |
Selective reporting (reporting bias) | Low risk | Planned outcomes reported in full |
Other bias | Low risk | No other sources of bias identified |