Berry 2011.
| Methods | Study design: Feasibility study – single‐blind parallel‐group RCT with 3 groups Location: Australia Number of centres: 1 Study period: Not stated Funding source: Hospital |
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| Participants | Setting: A 20‐bed adult intensive care unit in a university hospital Inclusion criteria: All intubated patients admitted to the unit were considered for inclusion in the study provided they met the following criteria: able to be randomised within 12 hours of intubation, aged over 15 years and next‐of‐kin able to give informed consent Exclusion criteria: Patients were ineligible for study participation if they: required specific oral hygiene procedures in relation to maxillofacial trauma or dental trauma/surgery; had been in the ICU previously during the current period of hospitalisation; received irradiation or chemotherapy on admission to the ICU or in the preceding 6 weeks; or suffered an autoimmune disease. Informed consent was obtained for all participants and agreement to participate could be withdrawn at any time Number randomised: 225 (71, 76, 78 in Groups 1, 2, 3) Number evaluated: 109 (33, 33, 43 in Groups 1, 2, 3) Group 1 (chlorhexidine 0.2% aqueous) group: Age: 58.2 ± 19.4; M/F: 35/36; APACHE II Score: 22.8 ± 7.8 Group 2 (sodium bicarbonate mouthwash rinsed 2‐hourly): Age: 60.4 ± 17.5; M/F: 42/24; APACHE II Score: 22.0 ± 7.5 Group 3 (sterile water rinsed 2‐hourly): Age: 59.1 ± 18.1; M/F: 44/34; APACHE II Score: 21.6 ± 7.8 |
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| Interventions |
Comparison: Chlorhexidine 0.2% versus water versus sodium bicarbonate Group 1: Twice daily irrigation with chlorhexidine 0.2% aqueous oral rinse with 2‐hourly irrigation with sterile water Group 2: Sodium bicarbonate mouthwash rinsed 2‐hourly Group 3: sterile water rinsed 2‐hourly (used as the control in this review) "All treatment options included a comprehensive cleaning of the mouth using a soft, pediatric toothbrush 3 times a day" |
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| Outcomes | 3 outcome variables were reported: 1. Microbial colonisation of dental plaque (or gums in edentulous participants) 2. Incidence of VAP 3. Adverse events |
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| Notes | Sample size calculation: Feasibility study to inform sample size calculation for main study | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "...randomisation into one of three groups according to a balanced randomisation table prepared by biostatistician" |
| Allocation concealment (selection bias) | Low risk | Study packs were identical in outward appearance and allocation remained blinded until study pack opened by attending nurse |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants: Blinding not possible, but non‐blinding of caregivers may have introduced a risk of bias |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Microbiologist and radiologists who assessed outcomes were blinded to allocated treatment |
| Incomplete outcome data (attrition bias) All outcomes | High risk | 102/225 participants evaluated. High rate of attrition and reasons varied in each group. Death rate higher in Group B, breach of inclusion criteria more likely in Groups B & C |
| Selective reporting (reporting bias) | Low risk | Planned outcomes reported |
| Other bias | High risk | Study stopped early due to withdrawal of investigational product by regulator |