Khaky 2018.
Study characteristics | ||
Methods | Study design: Two‐arm parallel‐group RCT Location: Iran Number of centres: one Study period: November 2016 to May 2017 Funding source: Not mentioned |
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Participants | Setting: ICU Inclusion criteria: age between 18 to 70 years old, lack of clear trauma to the jaw and face that prevents oral care, having tracheal tube, locating the patient under mechanical ventilation, lack of pneumonia or respiratory infections at the beginning of entry to the hospital (MCPIS < 7) up to 48 hours after intubation and there was no ban in respect of using Nanosil or Chlorhexidine such as allergy. Exclusion criteria: none Number randomised: 80 (gp A: 40; gp B: 40) Number evaluated: 75 (gp A: 37; gp B: 38) Baseline characteristics: ‐Gp A: (Age: 41.6 ± 15.9; M/F: 29/11; APACHE II score: not reported) ‐Gp B: (Age: 44.1 ± 16.5; M/F: 27/13; APACHE II score: not reported) |
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Interventions |
Comparison: Nanosil versus 2% Chlorhexidine Gp A (Nanosil): Patients in the case group received oral care with same method except that Nanosil was used instead of chlorhexidine. The intervention continued for five days or until obtaining the exit criteria. Gp B (Chlorhexidine): Patients in the control group received standard treatment. For these patients, oral care was done by 15 mL of a 2% chlorhexidine solution, 3 times per day for five days that involved brushing the teeth, suctioning oral secretions, and rubbing the oropharyngeal mucosa. |
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Outcomes | 1. VAP incidence (five days after initiation of intubation) 2. Mortality (five days after initiation of intubation) 3. MCPIS 4. SOFA 5. GCS |
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Notes | Sample size calculation: Not reported Other information of note: None |
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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) | Unclear risk | Not described |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Blinding not described and not possible. Difference between intervention and control meant caregivers would have been 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 | Unclear risk | “During the study, 3 patients in the case group and 2 patients in the control group were excluded.” Reasons for exclusion were not provided. |
Selective reporting (reporting bias) | High risk | Mortality‐related data were not reported. |
Other bias | Low risk | No other sources of bias identified |