Demory 2007.
Methods | Single‐centre RCT in France from November 2003 to December 2004 | |
Participants | 43 (28 included in this review) adults (mean age 49) with ARDS and PaO₂/FiO₂ < 150 and PEEP ≥ 5 cm H₂O | |
Interventions | 3100B high‐frequency oscillatory ventilator (SensorMedics). Initial settings were FiO₂ 1.0, frequency of 5 Hz with inspiratory time of 33%, mPaw of CV+ 5 cm H₂O (but ≤ plateau pressure), pressure amplitude of oscillation = PaCO₂ during conventional mechanical ventilation (max 110) Controls were ventilated with volume‐assist control with tidal volume 6 ‐ 7 mL/kg predicted body weight. PEEP was adjusted according to the ARDSNet protocol Participants included in this review were randomized to receive conventional mechanical ventilation in the prone position for 12 hours prior to: supine HFO (intervention, n = 13), or supine conventional mechanical ventilation (control, n = 15). A third group (n = 15) was randomly assigned to conventional ventilation in the supine position for 12 hours, followed by HFO, and was not included in this review |
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Outcomes | Physiologic data including PaO₂/FiO₂, OI, venous admixture | |
Notes | Duration of HFO was limited to 12 hours; therefore we included only physiologic data (PaO₂/FiO₂ and OI) in pooled analyses Recruitment manoeuvres were performed at HFO initiation, but not during conventional mechanical ventilation. Sedation and paralysis were applied equally to both treatment groups |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated list of random numbers (email correspondence, L Papazian, 9 August 2011) |
Allocation concealment (selection bias) | Low risk | Sealed opaque envelopes (email correspondence, L Papazian, 9 August 2011) |
Blinding (performance bias and detection bias) All outcomes | Low risk | Although blinding of caregivers and family members was not possible, the use of protocols, equal application of sedation and paralysis, and short study duration, likely minimizes the risk of performance bias The primary outcome, PaO₂/FiO₂, was measured from arterial blood in a standardized manner, and is therefore not likely to be susceptible to detection bias |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No incomplete outcome data |
Selective reporting (reporting bias) | Low risk | All primary and secondary outcomes reported; authors provided additional physiologic data for this review after being contacted |
Other bias | Low risk | No other source of bias identified |