Pobo 2009.

Methods	Study design: Prospective, single‐blind, randomised trial with parallel groups Location: Spain Number of centres: 1 ICU at a hospital Study period: Not stated Funding source: This work was supported by Fondo de Investigaciones Sanitarias (FISS 06/060), Centro de Investigación Biomédica en Red Enfermedades Respiratorias (06/06/36), and the Agency for the Administration of University and Research Grants (2005/SGR/920)
Participants	Inclusion criteria: Intubated adults without evidence of pulmonary infection, expected to remain ventilated for > 48 hours. Randomised within 12 hours of intubation Exclusion criteria: Edentulous, suspicion of pneumonia at time of intubation or evidence of massive aspiration during intubation, tracheostomy (or expected within 48 hours), recent enrolment in other trials, pregnancy, and chlorhexidine allergy Age group: Adults Intervention group: n = 74; age: 55.3 ± 17.9; M/F: 49/25; mean APACHE II Score: 18.8 ± 7.1 Control group: n = 73; age: 52.6 ± 17.2; M/F: 46/27; mean APACHE II Score: 18.7 ± 7.3 Number randomised: 147 (74 in toothbrush group and 73 in standard care group) Number evaluated: 147
Interventions	Comparison: Powered toothbrush + standard oral care versus standard oral care alone Group 1 (n = 74): Standard oral care plus toothbrush group: besides the standard oral care, toothbrushing was performed tooth by tooth, on anterior and posterior surfaces, and along the gumline, the tongue was also brushed. A powered toothbrush was used (Braun Oral B AdvancePower 450 TX, Braun GmbH). This procedure was repeated once every 8 hours Group 2 (n = 73): Standard oral care: maintaining head elevation at 30°. After aspiration of oropharyngeal secretions and adjustment of endotracheal cuff pressure, a gauze containing 20 ml of 0.12% chlorhexidine digluconate was applied to all the oral surfaces including tongue and mucosal surface, and 10 ml of 0.12% chlorhexidine digluconate was injected into oral cavity, being aspirated after 30 seconds, repeated every 8 hours
Outcomes	The following outcome variables were reported for each group: 1. Incidence of VAP 2. Incidence of suspected VAP per 1000 days of mechanical ventilation 3. Mean days of mechanical ventilation (mean ± SD) 4. ICU length of stay (mean ± SD) 5. Mortality
Notes	In the review, the standard oral care group was viewed as intervention with chlorhexidine and the other group was viewed as control with toothbrushing Sample size calculation: Estimated that 200 participants would be required in each group to show a 50% reduction in VAP with 80% power and α error of 5%. After 147 of planned 400 participants were randomised, the study was stopped by the steering committee due to no difference in VAP between the groups NCT 00842478 at ClinicalTrials.gov
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Randomisation by means of a computer‐generated list, stratified for antibiotic use at admission
Allocation concealment (selection bias)	Low risk	The list was concealed in opaque sealed envelopes opened by the nurse within 12 hours of intubation
Blinding of participants and personnel (performance bias) All outcomes	High risk	Blinding not possible. Participants unlikely to be aware of treatment, but caregivers were aware
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Investigators and attending physicians were blinded to assigned groups
Incomplete outcome data (attrition bias) All outcomes	Low risk	No withdrawals. All randomised participants included in the analysis
Selective reporting (reporting bias)	Low risk	Expected outcomes reported, including adverse events
Other bias	High risk	Study stopped early after recruitment of 147 of planned 400 participants because no differences between groups were found and revised estimates indicated that 1500 participants would need to be recruited to show a difference. Numbers not feasible in this centre