Huh 2009.
| Methods | Randomized controlled trial. Time period of study: July 2004 through September 2006. | |
| Participants | 57 participants (one centre). Included: ARDS (PaO2/FIO2 ≤ 200). Conditions excluded: elevated intracranial pressure, severe acute cardiac disease, high risk of mortality within 3 months for reasons other than ARDS (cancer patients in the terminal stage of their disease), persistent haemodynamic instability. | |
| Interventions | Control (27) and intervention (30): MV: VT: 6 mL/kg PBW, with allowances of up to 8 mL/kg PBW if the SpO2 were below 88%, or less than 7.2 of arterial pH by severe hypercapnoea.FIO2, PEEP, and respiratory rate were set to achieve an SpO2 between 88% and 92%. PEEP. Control: PEEP/FIO2 combination with the goal of obtaining a lower PEEP level compatible with an oxygenation target (SpO2 between 88% and 92%). Mean PEEP: 9 cm H2O. Intervention: recruiting manoeuvres (extended‐sigh method), next PEEP added set to 25 cm H2O and then lowered until a decrease of greater than 2% of saturation from the previous SpO2 and drop of static compliance. |
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| Outcomes | Primary: improvement in oxygenation (PaO2/FIO2). Secondary: respiratory mechanics (PEEP and dynamic compliance), ICU stay, duration of sedatives and paralysing agents, mortality at day 28, mortality at day 60, duration of MV. |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Allocation intervention was done by random number table. |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information to permit judgement of "low risk" or "high risk". |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Incomplete blinding (blinding of participants but not personnel), but outcomes not influenced. |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | No blinding, but outcomes not influenced. |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Insufficient reporting of exclusions. Three out of 30 participants missing from control group and 1 out of 31 participants missing from intervention group. |
| Selective reporting (reporting bias) | Low risk | Published reports included all expected outcomes. |
| Other bias | Low risk | Review author believed the study to be free of other sources of bias. |