Rello 2006.
Methods | Mulitcentre, prospective, randomized, single‐blind, controlled study | |
Participants | Setting: 4 centres (3 Spain & 1 USA) Inclusion criteria: Mechanical ventilation for 24 hours and 18 years old Exclusion criteria: Respiratory infection, bronchiectasis, haematemesis, haemoptysis, or cystic fibrosis; sensitivity to silver or silver compounds; immunosuppression; and, in the substudy only, intubation within 30 days and pregnancy Participant numbers: 155 randomly assigned, 34 excluded (6 not intubated, 28 intubated < 24 h); 149 all intubated; 121 intubated ≥ 24 h analysed; 61 silver‐coated ETT versus 60 non‐coated ETT who were intubated for ≥ 24 h | |
Interventions | Silver‐coated ETT (7.5 mm to 8.5 mm internal diameter, high‐volume/low‐pressure) for 7.7 days versus non‐coated ETT (7.5 mm to 8.5 mm internal diameter, high‐volume/low‐pressure) for 5.9 days | |
Outcomes | Hospital mortality; device‐related adverse events | |
Notes | Risk of VAP was not reported Cause of hospital mortality was not specified in this study |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated randomization sequence |
Allocation concealment (selection bias) | Low risk | No details given in manuscript. After contacting study authors: Adequate allocation concealment with central randomization by telephone, with different lists for each institution |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Investigators were blinded to block length; microbiology laboratory personnel were blinded to group assignments |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Single‐blinded study design. The ICU investigators could not be blinded |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 0% of participants lost to follow‐up. |
Selective reporting (reporting bias) | Low risk | All outcomes described in methods section reported |
Other bias | Low risk | None was apparent |
APACHE = Acute Physiology and Chronic Health Evaluation;
ARDS = acute respiratory distress syndrome;
BAL = bronchoalveolar lavage;
ETT = endotracheal tube;
ICU = intensive care unit;
PEEP = positive end‐expiratory pressure;
VAP = ventilator‐associated pneumonia.