Agarwal 2013.
Methods | Randomized controlled trial in a single respiratory ICU | |
Participants | Adults with acute respiratory distress syndrome | |
Interventions | Intervention: ASV. Patients were stabilized on volume control assist ventilation for 1 hour to determine the adequate minute ventilation.Peak pressure alarm was set at 45 cm H2O to avoid Pplat ≥35 cm H2O. Subsequent manipulation of %MV was guided by interpretation of the following parameters: Pinsp, spontaneous respiratory frequency while on ASV (fspont) and target respiratory frequency (ftarget) calculated by the ASV algorithm. If the fspont was greater than ftarget by 10 breaths and/or associated was hypoxaemia (PaO2 <55 mm Hg or SpO2 <88%) or hypercapnic acidosis (pH <7.25), then the %MV was escalated by 20%. If the fspont was similar to ftarget without any hypercapnoea or hypoxaemia, then the %MV was de‐escalated by 10%. The pressurization slope (percentage of the inspiratory time taken to reach the peak pressure) was maintained at 25% for all subjects. Weaning comprised sequential decrease in %MV every 2 h (or earlier). Spontaneous breathing trial was considered once %MV was ≤ 70% and Pinsp was ≤ 8 cmH2O. Patients were extubated if able to tolerate the spontaneous breathing trial for 60 min. Control: assist control mode ventilation using low tidal volume strategy of 6ml/kg to maintain plateau pressures < 30 cm H2O and pH > 7.3 with option to reduce tidal volume to 4 ml/kg and increase respiratory rate to 35/ min to achieve the above said goals. PSV weaning commenced once PEEP and FiO2 requirements decreased to 8 cm H2O and 0.4 respectively. The PS used was the Pplat recorded during VCV (PSmax). PS was decreased by 2 cmH2O every 6 h (or earlier) until PS of 7 cmH2O. A 1 hour SBT viaT‐piece off ventilator was then performed. FIO2/PEEP was set according to ARDSnet protocol for both study arms to maintain SpO2 of 88–92% at minimum possible FiO2. |
|
Outcomes | Duration of mechanical ventilation Duration of ICU stay Duration of hospital stay Mortality Ease of use of ventilator mode Frequency of blood gas analysis |
|
Notes | NCT01165528 | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomization sequence was computer generated |
Allocation concealment (selection bias) | Low risk | Assignments were placed in sealed opaque envelopes |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No attrition, no missing outcome data |
Selective reporting (reporting bias) | Low risk | All pre‐specified outcomes are reported |
Other bias | Low risk | No other sources of bias detected |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Assumed as high risk due to the nature of the intervention |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Outcome assessors were also involved in treatment of patients |