Fourrier 2000.
| Methods | Study design: Single‐blind RCT Location: Lille, France Number of centres: 1 Study period: June 1997 to July 1998 Funding source: Not stated |
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| Participants | Setting: Adult ICU Inclusion criteria: Patients admitted to ICU aged > 18 years, medical condition likely to require ICU stay of 5 days, requiring mechanical ventilation by oropharyngeal or nasopharyngeal intubation or tracheostomy Exclusion criteria: Edentulous patients Number randomised: 60 Number evaluated: 58 Baseline characteristics: ‐ Intervention group: Age: 51.2 ± 15.2; M/F: 19/11; SAPS II Score: 37 ± 15 ‐ Control group: Age: 50.4 ± 15.5; M/F: 19/11; SAPS II Score: 33 ± 13 |
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| Interventions |
Comparison: Rinse + chlorhexidine gel versus rinse alone Experimental group: After mouth rinsing and oropharyngeal aspiration, 0.2% chlorhexidine gel was applied to dental and gingival surfaces of the patient using glove‐protected finger. Intervention 3 times daily Control group: Mouthrinsing with bicarbonate isotonic serum followed by gentle oropharyngeal aspiration 4 times daily during ICU stay Participants were allowed to eat and drink freely |
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| Outcomes | 1. Incidence of nosocomial infections 2. Dental status (DMFT/CAO) 3. Amount of dental plaque (Loe & Silness Index) 4. Plaque bacterial culture |
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| Notes | Sample size calculation: Not reported Investigators verified antibacterial activity of chlorhexidine gel in vitro prior to study Unclear numbers on mechanical ventilation developing VAP. Email sent 14 November 2012 |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "...patients were randomized into two groups according to a computer‐generated balanced randomization table" |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information was reported to determine whether or not the allocation of the sequence was concealed |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Not possible as no placebo used |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Bacteriologist blinded to randomisation code, and evaluation of nosocomial infections done by hygienist nurse and physician not aware of the treatment given |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Unclear how many participants are included in the evaluation of the outcomes |
| Selective reporting (reporting bias) | Low risk | Planned outcome of nosocomial infection, dental plaque, and colonisation reported |
| Other bias | Low risk | Groups appear similar at baseline. No other sources of bias identified |