通过皮肤进行耳膜迷走神经刺激对败血症引起的凝血病的影响:随机对照试验的协议
Chun Yang1, Jixiang Zhu2, Yingying Zhang1
1Department of Anesthesiology, First Affiliated Hospital of Soochow University, Suzhou, Jiangsu, China.
BMJ open
|August 11, 2025
概括
通过皮肤进行耳道迷走神经刺激 (taVNS),可以通过调节炎症和凝血来改善败血症诱导的凝血病 (SIC). 这项随机试验将评估taVNS在增强SIC患者凝血功能的有效性.
科学领域:
- 关键护理医学 关键护理医学
- 神经调节是一种神经调节.
- 凝血障碍 凝血障碍 凝血障碍
背景情况:
- 败血症引起的凝血病 (SIC) 是败血症的严重并发症,增加死亡率.
- 目前SIC的治疗仅限于支持性护理.
- 通过皮肤进行的耳膜迷走神经刺激 (taVNS) 显示出调节炎症和凝血通路的潜力.
研究的目的:
- 评估taVNS在改善SIC患者凝血功能障碍方面的疗效和安全性.
- 为了确定taVNS是否可以在7天内导致SIC分数的显著改善.
主要方法:
- 一个单中心,随机化,假控制,单盲试验,涉及184名成人SIC患者.
- 参与者将每天两次接受活跃的taVNS或假刺激,持续7天.
- 主要结局:到第7天,SIC评分有≥2点改善的患者比例. 二次结局包括各种凝血标志物和临床终点.
主要成果:
- 当研究完成并可获得结果后,该部分应填写.
结论:
- 当研究完成并可获得结果后,该部分应填写.
相关概念视频
02:07Blind Procedures
Ideally, the people who observe and record the children’s behavior are unaware of who was assigned to the experimental or control group, in order to control for experimenter bias. Experimenter bias refers to the possibility that a researcher’s expectations might skew the results of the study. Remember, conducting an experiment requires a lot of planning, and the people involved in the research project have a vested interest in supporting their hypotheses. If the observers knew which child was...
01:11Blinding
Blinding is a commonly used method of not telling participants which treatment a subject is receiving. Blinding is a critical part of a randomized control trial or RCT. It reduces the bias that affects the results. In an RCT, blinding is used in the form of a placebo. A placebo effect occurs when untreated subjects falsely believe they have received the treatment and report improved symptoms. A placebo or a dummy treatment is administered to subjects to negate the bias caused by such an effect.