Department of Anesthesiology, Intensive Care and Pain Medicine, BG University Hospital Bergmannsheil, Ruhr-University Bochum, Buerkle de La Camp-Platz 1, 44789, Bochum, Germany.
Department of Medical Informatics, Biometry & Epidemiology, Ruhr-University Bochum, 44780, Bochum, Germany.
Trials. 2023 Mar 16;24(1):195. doi: 10.1186/s13063-023-07201-7.
In on-pump cardiac surgery, lungs are at high risk of periprocedural organ impairment because of atelectasis formation, ventilator-induced lung injury, and hyperinflammation due to the cardiopulmonary bypass which results in postoperative pulmonary complications in half of this patient population. The new ventilation mode flow-controlled ventilation (FCV) uniquely allows full control of ins- and expiratory airway flows. This approach reduces the mechanical power of invasive ventilation as a possible cause of ventilator-induced lung injury. The scope of FLOWVENTIN HEARTSURG is to compare perioperative individualized FCV with best clinical practice pressure-controlled ventilation (PVC) modes in patients with elective on-pump cardiac surgery procedures. We hypothesize that the postoperative inflammatory response can be reduced by the perioperative application of FCV compared to PCV.
FLOWVENTIN HEARTSURG is a single-center, randomized, parallel-group trial with two intervention arms: perioperative PCV modes (n = 70, PCV group) with an individualized positive end-expiratory pressure (PEEP) and a tidal volume of 6-8 ml/kg predicted bodyweight compared to perioperative FCV (n = 70, FCV group) with an individualized PEEP and driving pressure, resulting in a liberal tidal volume. As the primary study endpoint interleukin 8 plasma level is assessed 6 h after cardiopulmonary bypass as a surrogate biomarker of systemic and pulmonary inflammation. As secondary aims clinically relevant patient outcomes are analyzed, e.g., perioperative lung function regarding oxygenation indices, postoperative pulmonary and extra-pulmonary complications, SIRS-free days as well as ICU and total inpatient stays. As additional sub-studies with an exploratory approach perioperative right ventricular function parameters are assessed by echocardiography and perioperative lung aeration by electrical impedance tomography.
Current paradigms regarding protective low tidal volume ventilation are consciously left in the FCV intervention group in order to reduce mechanical power as a determinant of ventilator-induced lung injury in this high-risk patient population and procedures. This approach will be compared in a randomized controlled trial with current best clinical practice PCV in FLOWVENTIN HEARTSURG.
German Clinical Trials Register DRKS00018956 . Registered on 12 June 2020 (Version 1), last update on 22 August 2022 (Version 4).
在体外循环心脏手术中，由于肺不张形成、呼吸机诱导的肺损伤和体外循环引起的过度炎症，肺部在围手术期存在器官损伤的高风险，导致一半的患者术后发生肺部并发症。新型通气模式流量控制通气（FCV）独特地允许对吸气和呼气气道流量进行完全控制。这种方法减少了有创通气的机械功率，这可能是呼吸机诱导的肺损伤的一个原因。FLOWVENTIN HEARTSURG 的研究范围是比较择期体外循环心脏手术患者围手术期个体化 FCV 与最佳临床实践压力控制通气（PCV）模式。我们假设与 PCV 相比，围手术期应用 FCV 可以减轻术后炎症反应。
FLOWVENTIN HEARTSURG 是一项单中心、随机、平行组试验，有两个干预组：围手术期 PCV 模式（n=70，PCV 组）采用个体化呼气末正压（PEEP）和 6-8ml/kg 预测体重的潮气量，与围手术期 FCV（n=70，FCV 组）采用个体化 PEEP 和驱动压力，导致潮气量宽松。作为主要研究终点，白细胞介素 8 血浆水平在体外循环后 6 小时评估，作为全身和肺炎症的替代生物标志物。作为次要目标，分析临床相关的患者结局，例如围手术期氧合指数相关的肺功能、术后肺和肺外并发症、SIRS 无天数以及 ICU 和总住院时间。作为探索性亚研究，通过超声心动图评估围手术期右心室功能参数，通过电阻抗断层扫描评估围手术期肺充气。
在 FCV 干预组中，有意识地保留保护性低潮气量通气的现有范式，以减少机械功率作为该高危患者人群和手术中呼吸机诱导的肺损伤的决定因素。在 FLOWVENTIN HEARTSURG 中，将这种方法与当前最佳临床实践 PCV 进行随机对照试验比较。
德国临床试验注册中心 DRKS00018956。于 2020 年 6 月 12 日注册（第 1 版），2022 年 8 月 22 日更新（第 4 版）。
