BACKGROUND: Many new mechanical ventilation modes are proposed without any clinical evaluation. "Dual-controlled" modes, such as AutoFlow™, are supposed to improve patient- ventilator interfacing and could lead to fewer alarms. We performed a long-term clinical evaluation of the efficacy and safety of AutoFlow during assist-controlled ventilation, focusing on ventilator alarms. METHODS:Forty-two adult patients, receiving mechanical ventilation for more than 2 days with a Dräger Evita 4 ventilator were randomized to conventional (n = 21) or AutoFlow (n = 21) assist-controlled ventilation. Sedation was given using a nurse-driven protocol. Ventilator-generated alarms were exhaustively recorded from the ventilator logbook with a computer. Daily blood gases and ventilation outcome were recorded. RESULTS: A total of 403 days of mechanical ventilation were studied and 45,022 alarms were recorded over a period of 8074 hours. The course of respiratory rate, minute ventilation, Fio(2), positive end-expiratory pressure, Pao(2)/Fio(2), Paco(2), and pH and doses and duration of sedation did not differ between the 2 groups. Outcome (duration of mechanical ventilation, ventilator-associated pneumonia, course of Sequential Organ Failure Assessment score, or death) was not different between the 2 groups. The number of alarms per hour was lower with AutoFlow assist-controlled ventilation: 3.3 [1.5 to 17] versus 9.1 [5 to 19], P < 0.0001 (median [quartile range]). In multivariate analysis, a low alarm rate was associated with activation of AutoFlow and a higher midazolam dose. CONCLUSIONS: This first long-term clinical evaluation of the AutoFlow mode demonstrated its safety with regard to gas exchange and patient outcome. AutoFlow also allowed a very marked reduction in the number of ventilator alarms.
RCT Entities:
BACKGROUND: Many new mechanical ventilation modes are proposed without any clinical evaluation. "Dual-controlled" modes, such as AutoFlow™, are supposed to improve patient- ventilator interfacing and could lead to fewer alarms. We performed a long-term clinical evaluation of the efficacy and safety of AutoFlow during assist-controlled ventilation, focusing on ventilator alarms. METHODS: Forty-two adult patients, receiving mechanical ventilation for more than 2 days with a Dräger Evita 4 ventilator were randomized to conventional (n = 21) or AutoFlow (n = 21) assist-controlled ventilation. Sedation was given using a nurse-driven protocol. Ventilator-generated alarms were exhaustively recorded from the ventilator logbook with a computer. Daily blood gases and ventilation outcome were recorded. RESULTS: A total of 403 days of mechanical ventilation were studied and 45,022 alarms were recorded over a period of 8074 hours. The course of respiratory rate, minute ventilation, Fio(2), positive end-expiratory pressure, Pao(2)/Fio(2), Paco(2), and pH and doses and duration of sedation did not differ between the 2 groups. Outcome (duration of mechanical ventilation, ventilator-associated pneumonia, course of Sequential Organ Failure Assessment score, or death) was not different between the 2 groups. The number of alarms per hour was lower with AutoFlow assist-controlled ventilation: 3.3 [1.5 to 17] versus 9.1 [5 to 19], P < 0.0001 (median [quartile range]). In multivariate analysis, a low alarm rate was associated with activation of AutoFlow and a higher midazolam dose. CONCLUSIONS: This first long-term clinical evaluation of the AutoFlow mode demonstrated its safety with regard to gas exchange and patient outcome. AutoFlow also allowed a very marked reduction in the number of ventilator alarms.