Department of Anaesthesiology, Intensive Care, Emergency and Pain Medicine, University Hospital Würzburg, Oberdürrbacher Str. 6, 97080, Würzburg, Germany.
Clinical Trial Center, University Hospital Würzburg, Josef-Schneider-Str. 2, 97080, Würzburg, Germany.
BMC Anesthesiol. 2023 Apr 18;23(1):128. doi: 10.1186/s12871-023-02083-3.
Data on the routine use of video-assisted laryngoscopy in peri-operative intubations are rather inconsistent and ambiguous, in part due to small populations and non-uniform outcome measures in past trials. Failed or prolonged intubation procedures are a reason for relevant morbidity and mortality. This study aims to determine whether video-assisted laryngoscopy (with both Macintosh-shaped and hyperangulated blades) is at least equal to the standard method of direct laryngoscopy with respect to the first-pass success rate. Furthermore, validated tools from the field of human factors will be applied to examine within-team communication and task load during this critical medical procedure.
In this randomized, controlled, three-armed parallel group design, multi-centre trial, a total of more than 2500 adult patients scheduled for perioperative endotracheal intubation will be randomized. In equally large arms, video-assisted laryngoscopy with a Macintosh-shaped or a hyperangulated blade will be compared to the standard of care (direct laryngoscopy with Macintosh blade). In a pre-defined hierarchical analysis, we will test the primary outcome for non-inferiority first. If this goal should be met, the design and projected statistical power also allow for subsequent testing for superiority of one of the interventions. Various secondary outcomes will account for patient safety considerations as well as human factors interactions within the provider team and will allow for further exploratory data analysis and hypothesis generation.
This randomized controlled trial will provide a solid base of data in a field where reliable evidence is of major clinical importance. With thousands of endotracheal intubations performed every day in operating rooms around the world, every bit of performance improvement translates into increased patient safety and comfort and may eventually prevent significant burden of disease. Therefore, we feel confident that a large trial has the potential to considerably benefit patients and anaesthetists alike.
ClincalTrials.gov NCT05228288.
1.1, November 15, 2021.
关于在围手术期插管中常规使用视频辅助喉镜的数据相当不一致和模糊，部分原因是过去的试验中人口较少且结果测量方法不统一。插管失败或延长是导致相关发病率和死亡率的一个原因。本研究旨在确定视频辅助喉镜（包括 Macintosh 形状和超角度刀片）在首次通过成功率方面是否至少与直接喉镜标准方法相当。此外，将从人为因素领域应用经过验证的工具来检查在这一关键医疗过程中团队内的沟通和任务负荷。
在这项随机、对照、三臂平行组设计的多中心试验中，将对 2500 多名计划进行围手术期气管内插管的成年患者进行随机分组。在相等大小的组中，将比较使用 Macintosh 形状或超角度刀片的视频辅助喉镜与标准护理（Macintosh 刀片的直接喉镜）。在预先定义的分层分析中，我们将首先测试非劣效性的主要结局。如果达到这一目标，设计和预测的统计能力也允许随后测试其中一种干预措施的优越性。各种次要结局将考虑到患者安全考虑因素以及提供者团队内的人为因素相互作用，并允许进一步进行探索性数据分析和假设生成。
这项随机对照试验将为一个具有主要临床重要性的可靠证据的领域提供坚实的数据基础。全球手术室每天进行数千次气管内插管，每一点性能改进都转化为增加患者的安全性和舒适度，并最终可能预防重大疾病负担。因此，我们有信心，一项大型试验有可能使患者和麻醉师都受益。
ClincalTrials.gov NCT05228288。
1.1，2021 年 11 月 15 日。
