Fourrier 2005.
| Methods | Study design: A multicentre double‐blind placebo‐controlled study with 2 parallel groups Location: France Number of centres: 6 ICUs (3 in university hospitals & 3 in general hospitals) Study period: January 2001 to September 2002 Funding source: Partial funding from Programme Hospitalier de Recherche Clinique PHRC (French Ministry of Health) |
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| Participants | Inclusion criteria: Age > 18 years and a medical condition suggesting an ICU stay at least 5 days and the requirement for mechanical ventilation by orotracheal or nasotracheal intubation. Only patients hospitalised for 48 hours before admission in the ICU could be included Exclusion criteria: Patients with a tracheostomy tube at recruitment; completely edentulous; suffering from facial trauma; post‐surgical and requiring specific oropharyngeal care; known allergy to chlorhexidine Age group: Mean 61.0 SD 14.7, 61.1 years SD 14.9 in each group Number randomised: 228 Number evaluated: 228 (ITT) Intervention group: Age: 61.1 ± 14.9; M/F: 73/41; SAPS II Score: 45.0 ± 17.5 Control group: Age: 61.0 ± 14.7; M/F: 83/31; SAPS II Score: 45.2 ± 17.5 |
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| Interventions |
Comparison: Chlorhexidine gel versus placebo Intervention (n = 114): After mouthrinsing and aspiration, plaque antiseptic decontamination of gingival and dental plaque with a 0.2% chlorhexidine gel provided by nurses at least 3 times a day during the entire ICU stay Control (n = 114): A placebo gel, same usage as that of plaque antiseptic decontamination "Toothbrushing was not allowed in the protocol" |
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| Outcomes | The following variables were reported and compared: 1. Incidence of VAP 2. Incidence of VAP (%) per 1000 days of mechanical ventilation 3. Incidence of VAP (%) per 1000 days of intubation 5. Mortality from day 0 to day 28 6. ICU days (mean ± SD) 7. Days of intubation (mean ± SD) 8. Antibiotic days (mean ± SD) |
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| Notes | Sample size calculation: Calculation provided based on expected incidence of nosocomial infections of 30% in placebo group and 15% in treatment group. Planned interim analysis to determine effects of interventions, and study stopped based on pre‐planned stopping rule after this interim analysis Email sent to author 14 November 2012 |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "...randomly assigned … block randomization stratified by site" |
| Allocation concealment (selection bias) | Low risk | "all randomization lists were held in sealed envelopes in the pharmacy departments of the 6 centres" |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | The placebo gel was indistinguishable by colour, taste or odour from the tested agent. The investigators were unaware of participants' assignments |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Double blind |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Only 1 participant in intervention group was excluded and the reason was clearly explained. ITT analysis |
| Selective reporting (reporting bias) | Low risk | All planned outcomes clearly defined and reported |
| Other bias | Low risk | No other sources of bias identified. Although this study was stopped early, interim analysis was planned in protocol and carried out appropriately |