Dahiya 2012.
| Study characteristics | ||
| Methods | Study design: RCT Location: New Delhi, India Number of centres: 1 Study period: not reported Funding source: not reported |
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| Participants | Setting: ICU of All India Institute of Medical Sciences Inclusion criteria: adult patients (> 18 years) admitted to ICU on mechanical ventilation for < 24 hours Exclusion criteria: not reported Number randomised: 70 (CHX: 35; H2O2: 35) Number evaluated: 70 (CHX: 35; H2O2: 35) Baseline characteristics: not reported; only stated that the demographic characteristics including age and sex were comparable between two groups (P > 0.05) |
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| Interventions |
Comparison: 0.2% chlorhexidine gluconate solution versus hydrogen peroxide solution Oral decontamination was done for the groups twice daily at 8:00 a.m. and 7.00 p.m. for three consecutive days by the investigator. CHX: oral decontamination with 0.2% chlorhexidine gluconate solution (15 mL) twice daily at 8 a.m. and 7 p.m. for three consecutive days H2O2: oral decontamination using H2O2 with normal saline in a ratio of 1:8 (16 mL) twice daily at 8 a.m. and 7 p.m. for three consecutive days |
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| Outcomes | 1. Incidence of VAP 2. Oropharyngeal colonisation |
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| Notes | Sample size calculation: not reported Other information of note: study investigator replied to email 18 March 2020 and stated that 1) all included patients received MV for over 48 hours, 2) the CDC standard was used for diagnosis, and 3) VAP diagnosis was made at 48 and 72 hours. |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Not described |
| Allocation concealment (selection bias) | Low risk | “random assignment was done by using numbered sealed envelope method”. |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Blinding not described and not possible. Difference between intervention and control means caregivers would be aware of who was in each group. |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not described |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No dropouts |
| Selective reporting (reporting bias) | Low risk | Planned outcomes reported |
| Other bias | Unclear risk | Insufficient information in the trial report to produce confidence in the methodology of this trial |