Safety and efficacy of a fully closed-loop control ventilation (IntelliVent-ASV®) in sedated ICU patients with acute respiratory failure: a prospective randomized crossover study.

PURPOSE: IntelliVent-ASV(®) is a development of adaptive support ventilation (ASV) that automatically adjusts ventilation and oxygenation parameters. This study assessed the safety and efficacy of IntelliVent-ASV(®) in sedated intensive care unit (ICU) patients with acute respiratory failure.
METHODS: This prospective randomized crossover comparative study was conducted in a 12-bed ICU in a general hospital. Two periods of 2 h of ventilation in randomly applied ASV or IntelliVent-ASV(®) were compared in 50 sedated, passively ventilated patients. Tidal volume (V(T)), respiratory rate (RR), inspiratory pressure (P(INSP)), SpO(2) and E(T)CO(2) were continuously monitored and recorded breath by breath. Mean values over the 2-h period were calculated. Respiratory mechanics, plateau pressure (P(PLAT)) and blood gas exchanges were measured at the end of each period.
RESULTS: There was no safety issue requiring premature interruption of IntelliVent-ASV(®). Minute ventilation (MV) and V(T) decreased from 7.6 (6.5-9.5) to 6.8 (6.0-8.0) L/min (p < 0.001) and from 8.3 (7.8-9.0) to 8.1 (7.7-8.6) mL/kg PBW (p = 0.003) during IntelliVent-ASV(®) as compared to ASV. P(PLAT) and FiO(2) decreased from 24 (20-29) to 20 (19-25) cmH(2)O (p = 0.005) and from 40 (30-50) to 30 (30-39) % (p < 0.001) during IntelliVent-ASV(®) as compared to ASV. RR, P(INSP), and PEEP decreased as well during IntelliVent-ASV(®) as compared to ASV. Respiratory mechanics, pH, PaO(2) and PaO(2)/FiO(2) ratio were not different but PaCO(2) was slightly higher during IntelliVent-ASV(®) as compared to ASV.
CONCLUSIONS: In passive patients with acute respiratory failure, IntelliVent-ASV(®) was safe and able to ventilate patients with less pressure, volume and FiO(2) while producing the same results in terms of oxygenation.

RCT Entities:   Population Interventions Outcomes