Cabov 2010.
| Methods | Study design: 2 parallel‐arm RCT Location: Croatia Number of centres: 1 Study period: March 2008 to December 2008 Funding source: Supported by Croatian Ministry of Science Education and Sports Grant number 065‐1080057‐0429 |
|
| Participants | Setting: Surgical ICU in university hospital Inclusion criteria: Aged > 18 years, medical condition suggesting hospitalisation in ICU > 3 days, eventual requirement for mechanical ventilation by oropharyngeal or nasotracheal ventilation Exclusion criteria: Number randomised: 60. 40 of the 60 participants (17 and 23 in each group) were on mechanical ventilation Number evaluated: 60 Baseline characteristics: ‐Intervention group: Age: 57 ± 16; M/F: 19/11 ‐Control group: Age: 52 ± 19; M/F: 20/10 |
|
| Interventions |
Comparison: Chlorhexidine gel versus placebo Experimental group (n = 17): 3 times daily, following standard oral care comprising rinsing mouth with bicarbonate isotonic serum, followed by gentle oropharyngeal sterile aspiration, participants received application of 0.2% chlorhexidine gel applied by nurses to dental gingival and oral surfaces using a sterile gloved finger Control group (n = 23): Standard oral care, 3 times daily as above followed by administration of placebo gel In both groups gel was left in place and oral cavity was not rinsed |
|
| Outcomes | Simplified acute physiological score (SAPS), dental status, dental plaque, plaque culture, nosocomial infections, mortality | |
| Notes | Sample size calculation: Not reported | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "...randomized into two groups using a computer‐generated balanced randomization table" |
| Allocation concealment (selection bias) | Unclear risk | Unclear who conducted the allocation and whether it was concealed from the investigators |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double blind |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Double blind |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | All randomised participants included in outcome evaluations |
| Selective reporting (reporting bias) | Low risk | All planned outcomes reported |
| Other bias | Low risk | No other sources of bias identified |