BACKGROUND: One single-center randomized clinical trial showed that INTELLiVENT-adaptive support ventilation (ASV) is superior to conventional ventilation with respect to the quality of ventilation in post-cardiac surgery patients. Other studies showed that this automated ventilation mode reduces the number of manual interventions at the ventilator in various types of critically ill patients. In this multicenter study in patients post-cardiac surgery, we test the hypothesis that INTELLiVENT-ASV is superior to conventional ventilation with respect to the quality of ventilation.
METHODS: \"POStoperative INTELLiVENT-adaptive support VEntilation in cardiac surgery patients II (POSITiVE II)\" is an international, multicenter, two-group randomized clinical superiority trial. In total, 328 cardiac surgery patients will be randomized. Investigators screen patients aged > 18 years of age, scheduled for elective cardiac surgery, and expected to receive postoperative ventilation in the ICU for longer than 2 h. Patients either receive automated ventilation by means of INTELLiVENT-ASV or ventilation that is not automated by means of a conventional ventilation mode. The primary endpoint is quality of ventilation, defined as the proportion of postoperative ventilation time characterized by exposure to predefined optimal, acceptable, and critical (injurious) ventilatory parameters in the first two postoperative hours. One major secondary endpoint is ICU team staff workload, captured by the ventilator software collecting manual settings on alarms. Patient-centered endpoints include duration of postoperative ventilation and length of stay in ICU.
CONCLUSIONS: POSITiVE II is the first international, multicenter, randomized clinical trial designed to confirm that POStoperative INTELLiVENT-ASV is superior to non-automated conventional ventilation and secondary to determine if this closed-loop ventilation mode reduces ICU team staff workload. The results of POSITiVE II will support intensive care teams in their choices regarding the use of automated ventilation in postoperative care of uncomplicated cardiac surgery patients.
BACKGROUND: Clinicaltrials.gov NCT06178510 . Registered on December 4, 2023.

Driving pressure (ΔP) and mechanical power (MP) are associated with outcomes in critically ill patients, irrespective of the presence of Acute Respiratory Distress Syndrome (ARDS). INTELLiVENT-ASV, a fully automated ventilatory mode, controls the settings that affect ΔP and MP. This study compared the intensity of ventilation (ΔP and MP) with INTELLiVENT-ASV versus conventional ventilation in a cohort of COVID-19 ARDS patients in two intensive care units in the Netherlands. The coprimary endpoints were ΔP and MP before and after converting from conventional ventilation to INTELLiVENT-ASV. Compared to conventional ventilation, INTELLiVENT-ASV delivered ventilation with a lower ΔP and less MP. With conventional ventilation, ΔP was 13 cmH2O, and MP was 21.5 and 24.8 J/min, whereas with INTELLiVENT-ASV, ΔP was 11 and 10 cmH2O (mean difference -2 cm H2O (95 %CI -2.5 to -1.2 cm H2O), p < 0.001) and MP was 18.8 and 17.5 J/min (mean difference -7.3 J/Min (95% CI -8.8 to -5.8 J/min), p < 0.001). Conversion from conventional ventilation to INTELLiVENT-ASV resulted in a lower intensity of ventilation. These findings may favor the use of INTELLiVENT-ASV in COVID-19 ARDS patients, but future studies remain needed to see if the reduction in the intensity of ventilation translates into clinical benefits.

OBJECTIVE: the study purpose was to evaluate the efficacy of the IntelliVent-ASV mode in maintaining the target range of PaCO2 in patients with severe TBI.
METHODS: The study included 12 severe TBI patients with the wakefulness level scored 4-9 (GCS). This was a crossover design study. Two ventilation modes were consecutively used: IntelliVent-ASV and P-CMV, for 12 h each. When using the P-CMV mode, the ventilation parameters were set to maintain PaCO2 in a range of 35-38 mm Hg. The IntelliVent-ASV mode involved the Brain Injury ventilation algorithm. The target range of EtCO2 was set in accordance with the delta PaCO2-EtCO2 to maintain PaCO2 in a range of 35-38. At the beginning of each ventilation period and every 3 hours, the arterial blood gas composition was analyzed. When PaCO2 occurred out of the 35-38 range, appropriate adjustments were made to the ventilation parameters. In the P-CMV mode, the Pinsp and RR parameters were adjusted to achieve the target PaCO2 range. In IntelliVent mode, a shift of the target EtCO2 range was adjusted in accordance with a changed PaCO2-EtCO2 difference. In all patients, ICP, blood pressure, and EtCO2 were monitored; the arterial blood gas composition was analyzed every 3 h; the frequency of manual settings of ventilation parameters was recorded.
RESULTS: The EtCO2 and PaCO2 parameters were found not to be significantly different in the P-CMV and IntelliVent modes, but the spread in these parameters was significantly lower in the IntelliVent ventilation mode. The PaCO2 parameter occurred out of the target range significantly less often in the IntelliVent mode than in the P-CMV mode. The mean frequency of manual respirator settings needed to maintain the target EtCO2 range was significantly lower in the IntelliVent-ASV mode than in the P-CMV mode.
CONCLUSIONS: The IntelliVent-ASV mode provides more efficient maintenance of PaCO2 in the target range compared to traditional artificial ventilation using fewer manual settings of the ventilation parameters.
Цель исследования - оценить эффективность режима IntelliVent-ASV для поддержания целевого диапазона РаСО2 у пациентов с тяжелой ЧМТ. Материал и методы. В исследование включены 12 пациентов с тяжелой ЧМТ c угнетением уровня бодрствования до 4-9 баллов по шкале комы Глазго. Исследование имело дизайн кроссовера. Последовательно использовались два режима ИВЛ: IntelliVent-ASV и P-CMV по 12 ч каждый. При использовании режима P-CMV параметры вентиляции устанавливались таким образом, чтобы PaCO2 находился в диапазоне 35-38 мм рт.ст. При использовании режима IntelliVent-ASV включался алгоритм вентиляции Brain Injury. Целевой диапазон EtCO2 устанавливался в соответствии с дельтой PaCO2-EtCO2 таким образом, чтобы РаСО2 находилось в диапазоне 35-38 мм рт.ст. В начале каждого периода ИВЛ, а также каждые 3 ч выполнялся анализ газового состава артериальной крови. При выходе PaCO2 за границы 35-38 мм рт.ст. вносились соответствующие корректировки в параметры вентиляции. В режиме P-CMV для достижения целевого диапазона PaCO2 регулировались параметры Pinsp и частоты вдохов. В режиме IntelliVent регулировалось смещение целевого диапазона EtCO2 в соответствии с изменившейся разницей PaCO2-EtCO2. Всем пациентам проводился мониторинг внутричерепного давления, артериального давления, EtCO2, каждые 3 ч выполнялся анализ газового состава артериальной крови, фиксировалась частота ручных настроек параметров вентиляции. Результаты. В ходе исследования установлено, что показатели EtCO2 и PaCO2 при использовании режимов P-CMV и IntelliVent статистически значимо не различались, однако разброс этих показателей был существенно меньше при ИВЛ, проводимой в режиме IntelliVent. При использовании режима IntelliVent показатель PaCO2 выходил за рамки целевого диапазона существенно реже, чем при использовании режима P-CMV. Средняя частота необходимости ручных настроек респиратора для поддержания целевого диапазона EtCO2 при использовании режима IntelliVent-ASV была существенно ниже, чем при использовании режима P-CMV. Заключение. Использование режима IntelliVent-ASV позволяет более эффективно поддерживать РаСО2 в целевом диапазоне по сравнению с традиционной ИВЛ с использованием меньшего количества ручных настроек параметров вентиляции.

BACKGROUND: The discontinuation of mechanical ventilation after coronary surgery may prolong and significantly increase the load on intensive care unit personnel. We hypothesized that automated mode using INTELLiVENT-ASV can decrease duration of postoperative mechanical ventilation, reduce workload on medical staff, and provide safe ventilation after off-pump coronary artery bypass grafting (OPCAB). The primary endpoint of our study was to assess the duration of postoperative mechanical ventilation during different modes of weaning from respiratory support (RS) after OPCAB. The secondary endpoint was to assess safety of the automated weaning mode and the number of manual interventions to the ventilator settings during the weaning process in comparison with the protocolized weaning mode.
METHODS: Forty adult patients undergoing elective OPCAB were enrolled into a prospective single-center study. Patients were randomized into two groups: automated weaning (n = 20) using INTELLiVENT-ASV mode with quick-wean option; and protocolized weaning (n = 20), using conventional synchronized intermittent mandatory ventilation (SIMV) + pressure support (PS) mode. We assessed the duration of postoperative ventilation, incidence and duration of unacceptable RS, and the load on medical staff. We also performed the retrospective analysis of 102 patients (standard weaning) who were weaned from ventilator with SIMV + PS mode based on physician\'s experience without prearranged algorithm.
CONCLUSIONS: Realization of the automated weaning protocol required change in respiratory settings in 2 patients vs. 7 (5-9) adjustments per patient in the protocolized weaning group. Both incidence and duration of unacceptable RS were reduced significantly by means of the automated weaning approach. The FiO2 during spontaneous breathing trials was significantly lower in the automated weaning group: 30 (30-35) vs. 40 (40-45) % in the protocolized weaning group (p < 0.01). The average time until tracheal extubation did not differ in the automated weaning and the protocolized weaning groups: 193 (115-309) and 197 (158-253) min, respectively, but increased to 290 (210-411) min in the standard weaning group.
CONCLUSIONS: The automated weaning system after off-pump coronary surgery might provide postoperative ventilation in a more protective way, reduces the workload on medical staff, and does not prolong the duration of weaning from ventilator. The use of automated or protocolized weaning can reduce the duration of postoperative mechanical ventilation in comparison with non-protocolized weaning based on the physician\'s decision.