Talmor 2008.
| Methods | Randomized controlled trial. | |
| Participants | 61 participants, (one centre). Included: ALI and ARDS according to the AECC. Excluded: recent injury or other pathologic condition of the oesophagus, major bronchopleural fistula and solid‐organ transplantation. | |
| Interventions | In both groups, control (31) and intervention (30), the goals of MV included: a VT of 6 mL/kg PBW; a recruiting manoeuvre to standardize the history of lung volume, a PaO2 between 55 and 120 mm Hg or an SpO2 between 88% and 98%, an arterial pH of 7.30 to 7.45, and a PaCO2 of 40 to 60 mm Hg. PEEP: Control: PEEP/FIO2 combination. Intervention: Transpulmonary pressure (airway pressure minus pleural pressure) was determined, airway pressure was recorded during MV, and pleural pressure was estimated by an oesophageal balloon catheter. PEEP levels were set to achieve a transpulmonary pressure of 0 to 10 cm H2O at end‐expiration. All measurements were performed within 72 hours of patient inclusion. |
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| Outcomes | Primary: improvement in arterial oxygenation (PaO2/FIO2). Secondary: indices of lung mechanics and gas exchange (respiratory system compliance and the ratio of physiological dead space to tidal volume), VFD, length of stay in the ICU, days not spent in ICU, mortality at day 28, mortality at day 180, days of ventilation among survivors. |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Patients randomly allocated because authors used random allocation with the use of a block randomization scheme. |
| Allocation concealment (selection bias) | Low risk | Opaque sealed envelopes that were randomly ordered. |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Incomplete blinding (blinding of participants but not of personnel), but the outcomes not influenced. |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | No blinding, but outcomes not influenced by lack of blinding. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | In the experimental group, one participant who could not be assessed was included in the analysis on the basis of the intention‐to‐treat principle. |
| 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. |