手术中知晓事件的新分级标准

背景有外显记忆的手术中知晓事件的发生率仅为1／1000—2／1000。因其较罕见，为了更好的了解手术中知晓事件及其后遗效直，需要对大批量的研究数据进行统计。因此，对其进行标准描述和表达将很有价值。方法本研究创建了一种新的手术中知晓事件评估标准：0级：未发生手术中知晓；1级：仅存在听觉感知；2级：感知触觉（比如手术操作、气管插管）；3级：感知痛觉；4级：感知麻痹（比如感到不能活动、说话或呼吸）；5级：感知麻痹及痛觉。患者主述有恐惧、焦虑、窒息、末日感、濒死感及其他相关显性描述，另行附加“D”（distress[痛苦、悲伤]）。本研究回顾了15项详细提供手术中知晓报告信息的研究。来自3个研究并创建了该项分级标准的5位麻醉医生，各自独立的评估了这些病例。另外20名相关人员（麻醉主治医生、麻醉住院医生、麻醉护士、医学生及其辅助工作人员），虽未参与该分级标准的创建，但也独立对手术中知晓事件进行了评估。用Flwiss’s κ系数评估观察者之间的一致性。结果对151例确认发生手术中知晓事件的成年病例进行数据分析。基础评估1～5级中，总体κ系数为0．851（95％可信区间CI0．847～0．856）。包括附加情感障碍“D”的评估中，总体κ系数为0．779（95%可信区间CI 0．776～0．783）。结论本研究创建了新的手术中知晓事件评估标准，在评估者间具有近乎完美的一致性，这将有助于手术中知晓事件的研究。

BACKGROUND： Intraoperative awareness with explicit recall occurs in approximately 1 -2 cases per 1000. Given the rarity of the event, a better understanding of awareness and its sequelae will likely require the compilation of data from numerous studies. As such, a standard description and expression of awareness events would be of value. METHODS： We developed a novel classification instrument for intraoperative awareness events： Class 0： no awareness; Class 1： isolated auditory perceptions; Class 2： tactile perceptions （e. g., surgical manipulation or endotracheal tube）; Class 3： pain; Class 4： paralysis （e. g., feeling one cannot move, speak, or breathe）; and Class 5： paralysis and pain. An additional designation of ＂D＂ for distress was also included for patient reports of fear, anxiety, suffocation, sense of doom, sense of impending death, or other explicit descriptions. We reviewed 15 studies of the incidence of awareness that provided specific information about awareness reports. Five anesthesiologists at three institutions who developed the categories independently classified the events. An additional 20 individuals （attending anesthesiologists, anesthesiology residents, nurse anesthetists, medical students, and ancillary staff） not involved in the development of the categories also independently classified the events. Fleiss＇s kappa statistic was used to evaluate inter-observer agreement. RESULTS： One hundred fifty-one cases of intraoperative awareness in adults were identified as valid for analysis. The overall kappa value was 0. 851 （0. 847 - 0. 856, 95% confidence interval） for the basic Classes 1 -5. Including additional designations of emotional distress, the overall kappa value was 0. 779 （0. 776 -0. 783, 95% confidence interval）. CONCLUSION： We report a novel classification instrument for intraoperative awareness events that has excellent inter-observer agreement and that may facilitate the study of intraoperative awareness.