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. 2020 Dec 24;2020(12):CD008367. doi: 10.1002/14651858.CD008367.pub4

Ozcaka 2012.

Study characteristics
Methods Study design: double‐blind placebo‐controlled RCT
Location: Izmir, Turkey
Number of centres: 1
Study period: November 2007 to November 2009
Funding source: "The study was funded solely by the institutions of the authors".
Participants Setting: respiratory ICU
Inclusion criteria: patients aged 18 or over, admitted to respiratory ICU expecting to require ventilation for > 48 hours
Exclusion criteria: witnessed episode of aspiration, confirmed diagnosis of post‐obstructive pneumonia, known hypersensitivity to chlorhexidine, diagnosed thrombocytopenia, pregnancy, oral mucositis, readmission to same ICU, expected survival < 1 week, edentulism
Number randomised: 66
Number evaluated: 61
Baseline characteristics:
‐ Intervention group: age: 60.5 ± 14.7 years
‐ Control group: age: 56.0 ± 18.2 years
Interventions Comparison: chlorhexidine solution vs saline
Experimental group (n = 32): oral mucosa was swabbed with 0.2% chlorhexidine on sponge pellets, 4 times daily. Excess rinse was suctioned from patient's mouth after 1 minute.
Control group (n = 34): oral mucosa was swabbed with saline on sponge pellets, 4 times daily. Excess rinse was suctioned from patient's mouth after 1 minute.
Deep suctioning was performed in both groups every 6 hours and following position changes to remove pooled secretions from around the cuff of the endotracheal tube.
Outcomes 1. Incidence of VAP
2. Mortality
3. Duration of ventilation in ICU
4. Length of stay in ICU
5. Presence of potential respiratory pathogens in minibronchoalveolar lavage
Notes Sample size calculation: estimated that 28 participants would be required in each group to give 81% power with α of 5%, to show a reduction in VAP from 70% to 30%
Email sent 22 January 2013 and reply received 29 January 2013
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk "The randomisation prepared a set of subject identification (SID) numbers which had assigned treatment". Description unclear
Allocation concealment (selection bias) Unclear risk "Study nurse obtained the SID number when the patient was enrolled".
Blinding of participants and personnel (performance bias)
All outcomes Low risk "Assignment of treatment was blinded to patients and to all investigators, including periodontist,...respiratory ICU physicians and outcome statisticians".
Blinding of outcome assessment (detection bias)
All outcomes Low risk "Assignment of treatment was blinded to patients and to all investigators, including periodontist,...respiratory ICU physicians and outcome statisticians".
Incomplete outcome data (attrition bias)
All outcomes Low risk 66 participants randomised, 1 secondary exclusion from each group, and 2 and 1 early deaths in chlorhexidine and control groups, respectively. Unlikely to have introduced a bias
Selective reporting (reporting bias) Low risk Planned outcomes reported
Other bias Low risk No other sources of bias identified