Department of Anaesthesiology, Intensive Care Medicine and Pain Therapy, University Hospital Frankfurt, Goethe University Frankfurt, Germany, Klinikum der Johann Wolfgang Goethe-Universität Frankfurt, Frankfurt am Main, Hessen, Germany
Department of Biostatistic and Mathematic Modeling, Goethe University, Frankfurt, Germany, Goethe-Universitat Frankfurt am Main, Frankfurt am Main, Hessen, Germany.
BMJ Open. 2022 Feb 23;12(2):e057804. doi: 10.1136/bmjopen-2021-057804.
Patients undergoing heart valve surgery are predominantly transferred postoperatively to the intensive care unit (ICU) under continuous sedation. Volatile anaesthetics are an increasingly used treatment alternative to intravenous substances in the ICU. As subject to inhalational uptake and elimination, the resulting pharmacological benefits have been repeatedly demonstrated. Therefore, volatile anaesthetics appear suitable to meet the growing demands of fast-track cardiac surgery. However, their use requires special preparation at the bedside and trained medical and nursing staff, which might limit the pharmacological benefits. The aim of our work is to assess whether the temporal advantages of recovery under volatile sedation outweigh the higher effort of special preparation.
The study is designed to evaluate the differences between intravenous sedatives (n=48) and volatile sedatives (n=48) in continued intensive care sedation. This study will be conducted as a prospective, randomised, controlled, single-blinded, monocentre trial at a German university hospital in consenting adult patients undergoing heart valve surgery at a university hospital. This observational study will examine the necessary preparation time, staff consultation and overall feasibility of the chosen sedation method. For this purpose, the continuation of sedation in the ICU with volatile sedatives is considered as one study arm and with intravenous sedatives as the comparison group. Due to rapid elimination and quick awakening after the termination of sedation, closer consultation between the attending physician and the ICU nursing staff is required, in addition to a prolonged setup time. Study analysis will include the required setup time, time from admission to extubation as primary outcome and neurocognitive assessability. In addition, possible operation-specific (blood loss, complications), treatment parameters (catecholamine dosages, lung function) and laboratory results (acute kidney injury, acid base balance (lactataemia), liver failure) as influencing factors will be collected. The study-relevant data will be extracted from the continuous digital records of the patient data management system after the patient has been discharged from the ICU. For statistical evaluation, 95% CIs will be calculated for the median time to extubation and neurocognitive assessability, and the association will be assessed with a Cox regression model. In addition, secondary binary outcome measures will be evaluated using Fisher's exact tests. Further descriptive and exploratory statistical analyses are also planned.
The study was approved by the Institutional Ethics Board of the University of Frankfurt, Germany (#20-1050). Informed consent of all individual patients will be obtained before randomisation. Results will be disseminated via publication in peer-reviewed journals.
Clinical trials registration (NCT04958668) was completed on 1 July 2021.
接受心脏瓣膜手术的患者在术后主要被转入重症监护病房（ICU）进行持续镇静。挥发性麻醉剂在 ICU 中作为静脉内药物的替代治疗方法越来越受到关注。由于会被吸入和消除，因此其药理作用已反复得到证实。因此，挥发性麻醉剂似乎适合满足快速通道心脏手术的日益增长的需求。但是，其使用需要在床边进行特殊准备，并需要接受过培训的医疗和护理人员，这可能会限制其药理作用。我们的工作旨在评估在挥发性镇静下恢复的时间优势是否超过特殊准备的更高要求。
该研究旨在评估静脉镇静剂（n=48）与挥发性镇静剂（n=48）在 ICU 持续镇静中的差异。这项研究将在德国一所大学医院进行，作为一项前瞻性、随机、对照、单盲、单中心试验，在同意的成年患者中进行，这些患者在大学医院接受心脏瓣膜手术。这项观察性研究将检查所选镇静方法的必要准备时间、人员咨询和整体可行性。为此，将 ICU 中挥发性镇静剂的镇静作用作为一个研究臂，静脉镇静剂作为对照组。由于在镇静结束后迅速消除和快速苏醒，除了延长设置时间外，还需要主治医生和 ICU 护理人员之间进行更密切的咨询。研究分析将包括所需的设置时间、从入院到拔管的时间作为主要结果和神经认知可评估性。此外，还将收集可能与手术相关的因素（失血量、并发症）、治疗参数（儿茶酚胺剂量、肺功能）和实验室结果（急性肾损伤、酸碱平衡（乳酸血症）、肝功能衰竭）。研究相关数据将从患者从 ICU 出院后，从患者数据管理系统的连续数字记录中提取。对于统计评估，将计算中位数拔管时间和神经认知可评估性的 95%置信区间，并使用 Cox 回归模型评估关联。此外，还将使用 Fisher 确切检验评估次要二项式结果测量。还计划进行进一步的描述性和探索性统计分析。
该研究已获得德国法兰克福大学机构伦理委员会的批准（#20-1050）。将在随机分组前获得所有患者的知情同意。结果将通过在同行评议的期刊上发表来传播。
临床试验注册（NCT04958668）于 2021 年 7 月 1 日完成。
