Prendergast 2012.
| Methods | Study design: Prospective, randomised trial with 2 parallel groups. NCT 00518752 Location: USA Number of centres: 1 neuroscience ICU at a tertiary medical centre Study period: August 2007 to August 2009 Funding source: Not stated |
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| Participants | Inclusion criteria: All patients aged at least 18 years admitted to neuroscience ICU, intubated within 24 hours of admission Exclusion criteria: Pregnancy, edentulous, aged < 18 years, facial fractures or trauma affecting oral cavity, unstable cervical fractures, anticipated extubation within 24 hours, grim prognosis Intervention group: n = 38; age: 54 ± 17.8; M/F: 19/19 Control group: n = 40; age: 51 ± 18.4; M/F: 23/17 Number randomised: 78 (38 in comprehensive group and 40 in standard care group) Number evaluated: Variable (fewer than 11 participants/group) |
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| Interventions |
Comparison: Powered toothbrush + comprehensive oral care versus manual toothbrush + standard oral care Group 1 (n = 38): Tongue scraping using a low‐profile tongue scraper with posterior to anterior sweeping motion across the dorsal surface of the tongue. Then toothbrushing with Oral B vitality powered toothbrush + Biotene (non‐foaming) toothpaste for 2 minutes, then a liberal application or Oral Balance gel. Care performed twice daily Group 2 (n = 40): Standard oral care: using manual paediatric toothbrush, toothpaste with 1000 ppm fluoride with SLS and water‐based inert lubricant (KY jelly). Care performed twice daily |
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| Outcomes | The following outcome variables were reported for each group: 1. Oral and sputum cultures every 48 hours 2. Incidence of suspected VAP (day 2 ‐ 6) 3. ICU length of stay (mean ± SD) 4. Mortality |
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| Notes | Sample size calculation: Not reported NCT 00518752 at ClinicalTrials.gov |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "..randomized ... using a computer generated list maintained in a separate locked cabinet" |
| Allocation concealment (selection bias) | Low risk | "..list was maintained in a separate locked cabinet from enrolment forms to prevent manipulation of eligibility judgements" |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Not possible |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Diagnosis of VAP by examination of chest radiographs, by physicians blinded to allocated treatment (information in Prendergast dissertation) |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Unclear how many were assessed at each time point but paper states that "less than 11 patients in each group at each time point" |
| Selective reporting (reporting bias) | Low risk | All planned outcomes reported |
| Other bias | Low risk | No other sources of bias identified |