Dongelmans 2009.
Methods | Single centre randomized controlled trial | |
Participants | 128 adults (intervention 64:control 64) ≥18 years of age after uncomplicated coronary artery bypass grafting without a history of pulmonary disease or haemodynamic instability. Excluded patients comprised those with pulmonary disease or history of pulmonary surgery, intraaortic balloon pump on admission to ICU, receiving inotropes and/pr vasopressors at a rate higher than usual (upper limits in milligrams per hour: dopamine 20, norepinephrine 0.5, dobutamine 25, and epinephrine at any rate). Setting: The Netherlands, 28 bed ICU of academic medical centre. Staffing comprised 140 nurses, 8 full‐time intensivists, 8 ICU fellows, and 10 residents of other specialties |
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Interventions | Intervention: Adaptive Support Ventilation with the minute ventilation was set at 100% of the theoretical value based on predicted body weight, FiO2 of 50%, PEEP of 10 cmH2O (maintained constant for 4 hours after which it was set to 5cmH2O until extubation), maximum airway pressure of 35 cmH2O equivalent to an absolute Pinsp limit of 25cmH2O, flow trigger 2 L/s. Arterial blood gas (ABG) analysis was performed 30 minutes after connection to the ventilator. If the PaCO2 was <3.5 kPa or >5.5 kPa, minute ventilation was decreased or increased by 10%. Any modification of ventilator settings was followed after 30 minutes by an ABG. Extubation criteria included: responsive and cooperative, urine output >0.5 mL/kg/hr, chest drainage <100 mL last hour, no uncontrolled arrhythmia, rectal temperature >36.0C, respiratory frequency of 10‐20 breaths/min without machine‐controlled breaths, FiO2 40% and Pinsp 5‐10 cmH2O for 30 minutes. Control: Pressure Control Ventilation with VT of 6‐8 mL/kg predicted body weight, respiratory rate of 12‐15 breaths/min, FiO2, PEEP and flow trigger at same settings as ASV group. Respiratory rate was increased or decreased to satisfy ASV PaCO2 criteria on ABG taken 30 minutes after ventilation commenced. Any modification of ventilator settings was followed after 30 minutes by an ABG. When patients breathed spontaneously, the mode was switched to PSV set at 10 cmH2O, support was decreased to 5‐10 cmH2O depending on VT. Extubation criteria were the same as ASV group. |
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Outcomes | Primary endpoint was time to tracheal extubation. Secondary endpoints were the duration of assisted ventilation as the proportion of the total duration of ventilation of MV and switches from controlled ventilation to assisted ventilation. Also studied ASV with respect to VT, airway pressures, respiratory rate, and ABG results | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Allocation in random order (author communication) |
Allocation concealment (selection bias) | Low risk | Opaque, sealed envelopes used |
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 | Not possible due to nature of intervention |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Outcome assessors were not involved in daily care of patients. Assumed as low risk due to the objective nature of outcomes (weaning commencement/extubation) |