Seguin 2006.
| Methods | Study design: 3‐arm parallel RCT Location: Rennes, France Number of centres: 1 Study period: August 2001 to January 2003 Funding source: Not stated |
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| Participants | Setting: Surgical ICU Inclusion criteria: Adults (> 18 years) with closed head trauma admitted to ICU and expected to need mechanical ventilation for at least 2 days Exclusion criteria: Admitted > 12 hours after initial trauma, those with facial, thoracic, abdominal or spinal injuries, known history of reaction to iodine or of respiratory disease, chest infiltrates at admission or need for curative antibiotics Number randomised: 110 (38/36/36) Number evaluated: 98 (36/31/31) Baseline characteristics: ‐ Iodine group: Age: 38 ± 17 years; M/F: 28/10 ‐ Saline group: Age: 38 ± 16 years; M/F: 24/12 ‐ Control group: Age: 41 ± 18 years; M/F: 23/13 |
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| Interventions |
Comparison: Povidone Iodine versus saline versus usual care (no rinse) Iodine group (n = 38): Nasopharynx and oropharynx rinsed 4‐hourly with 20 ml of 10% povidone iodine aqueous solution (Betadine oral rinse solution) reconstituted in a 60 ml solution with sterile water, followed by aspiration of oropharyngeal secretions Saline group (n = 36): Nasopharynx and oropharynx rinsed 4‐hourly with 60 ml saline, followed by aspiration of oropharyngeal secretions Control group (n = 36): Standard regimen without any instillation but with aspiration of oropharyngeal secretions For all participants the suction catheters were inserted as distally as possible. Procedures were reported on patients chart |
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| Outcomes | 1. Incidence of VAP ‐ early and late onset 2. Duration of ventilation in surgical ICU 3. Length of stay in surgical ICU 4. Surgical ICU mortality |
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| Notes | Sample size calculation: Estimated that 30 participants in each group would provide 80% power with α error = 5% to detect a reduction in VAP from 50% to 20% | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "Patients were randomly assigned to received one of three regimens according to computer‐generated random number codes kept in sealed envelopes" |
| Allocation concealment (selection bias) | Low risk | "Patients were randomly assigned to received one of three regimens according to computer‐generated random number codes kept in sealed envelopes" |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Not possible |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Unclear information about blinding of outcome assessors |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 12 randomised participants (11%) excluded from analysis. 6 participants (1/3/2 in each group) were withdrawn because unexpected recovery meant that they were not on mechanical ventilation for 48 hours and a further 6 participants (1/2/3) died. Unlikely to have introduced a bias |
| Selective reporting (reporting bias) | Low risk | Planned outcomes reported in full |
| Other bias | Low risk | No other sources of bias identified |