Chassé Michaël, Shankar Jai Jai Shiva, Fergusson Dean A, English Shane W, Dhanani Sonny, Lauzier François, Turgeon Alexis F, Ball Ian, Darvesh Sultan, Neves Briard Joel, Essig Marco, Boucher-Roy David, Titova Polina, Lebrasseur Martine, Couillard Philippe, Kramer Andreas, D'Aragon Frédérick, Hannouche Mathew, Tampieri Donatella, Meade Maureen O, Menon Bijoy K, Green Robert, Baker Andrew J, Burns Karen E A, Zarychanski Ryan, Shahin Jason, Boyd J Gordon, Binnie Alexandra, Gibson Andrew, Wang Han Ting, Shemie Sam
Department of Medicine, Université de Montréal, Montréal, Québec, Canada.
Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montréal, Québec, Canada.
JAMA Neurol. 2025 Jun 13. doi: 10.1001/jamaneurol.2025.2375.
Accurate and timely confirmation of death by neurologic criteria (DNC) is essential for clinical decision-making and organ-donation processes, yet currently available ancillary tests have suboptimal diagnostic performance or limited validation.
To determine the diagnostic accuracy, interrater reliability, and safety of brain computed tomography (CT) perfusion and CT angiography as ancillary investigations for DNC.
DESIGN, SETTING, AND PARTICIPANTS: Between April 25, 2017, and March 10, 2021, a prospective, multicenter, blinded diagnostic accuracy cohort study was conducted in 15 adult intensive care units across Canada. Consecutive, critically ill adults (aged ≥18 years) with a Glasgow Coma Scale score of 3 and no confounding factors who were at high risk of DNC were included. Data collection and analysis were performed from April 2021 to July 2024.
Contrast-enhanced brain CT perfusion with CT angiography reconstructions performed within 2 hours of a blinded, standardized clinical DNC examination.
The primary outcomes were the sensitivity and specificity of qualitative and quantitative brainstem CT perfusion for DNC determination, assessed by 2 independent neuroradiologists blinded to clinical findings; the prespecified validation threshold was greater than 98%. Secondary outcomes were the diagnostic accuracy of whole-brain CT perfusion and CT angiography, interrater reliability (Cohen κ), and adverse events associated with imaging.
A total of 282 patients (mean [SD] age, 57.8 [15.4] years; 133 [47%] female) completed the study protocol and were included in the primary analysis; 204 (72%) of these were ultimately declared deceased by standardized clinical criteria. Qualitative brainstem CT perfusion showed a sensitivity of 98.5% (95% CI, 95.8%-99.7%) and a specificity of 74.4% (95% CI, 63.2%-83.6%); quantitative brainstem CT perfusion was not diagnostically accurate. Qualitative whole-brain CT perfusion yielded a sensitivity of 93.6% (95% CI, 89.3%-96.6%) and a specificity of 92.3% (95% CI, 84.0%-97.1%). CT angiography sensitivity ranged from 75.5% (95% CI, 69.0%-81.2%) to 87.3% (95% CI, 81.9%-91.5%), and its specificity ranged from 89.7% (95% CI, 80.8%-95.5%) to 91.0% (95% CI, 82.4%-96.3%). Interrater reliability was excellent for all ancillary tests (κ ranged from 0.81 [95% CI, 0.73-0.89] to 0.84 [95% CI, 0.78-0.91]). Fourteen patients (5%) experienced minor, self-limited adverse events; no serious adverse events occurred.
The observed sensitivity and specificity measures for CT perfusion and CT angiography as an ancillary test for DNC did not meet the prespecified validation threshold of greater than 98%. Clinical examination remains the cornerstone of DNC, and ancillary imaging should be interpreted cautiously within a comprehensive clinical assessment.
通过神经学标准准确及时地确认死亡对于临床决策和器官捐赠过程至关重要,但目前可用的辅助检查诊断性能欠佳或验证有限。
确定脑计算机断层扫描(CT)灌注和CT血管造影作为神经学标准判定死亡辅助检查的诊断准确性、评分者间可靠性和安全性。
设计、设置和参与者:2017年4月25日至2021年3月10日,在加拿大15个成人重症监护病房进行了一项前瞻性、多中心、盲法诊断准确性队列研究。纳入连续的格拉斯哥昏迷量表评分为3分且无混杂因素、有神经学标准判定死亡高风险的危重症成人(年龄≥18岁)。2021年4月至2024年7月进行数据收集和分析。
在标准化临床神经学标准判定死亡检查的盲法下2小时内进行对比增强脑CT灌注及CT血管造影重建。
主要结局是定性和定量脑干CT灌注用于判定神经学标准判定死亡的敏感性和特异性,由2名对临床结果不知情的独立神经放射科医生评估;预先设定的验证阈值大于98%。次要结局是全脑CT灌注和CT血管造影的诊断准确性、评分者间可靠性(Cohen κ)以及与成像相关的不良事件。
共282例患者(平均[标准差]年龄,57.8[15.4]岁;133例[47%]为女性)完成研究方案并纳入主要分析;其中204例(72%)最终根据标准化临床标准被宣布死亡。定性脑干CT灌注的敏感性为98.5%(95%置信区间,95.8%-99.7%),特异性为74.4%(95%置信区间,63.2%-83.6%);定量脑干CT灌注诊断不准确。定性全脑CT灌注的敏感性为93.6%(95%置信区间,89.3%-96.6%),特异性为92.3%(95%置信区间,84.0%-97.1%)。CT血管造影的敏感性范围为75.5%(95%置信区间,69.0%-81.2%)至87.3%(95%置信区间,81.9%-91.5%),其特异性范围为89.7%(95%置信区间,80.8%-95.5%)至91.0%(95%置信区间,82.4%-96.3%)。所有辅助检查的评分者间可靠性都很好(κ范围从0.81[95%置信区间,0.73-0.89]至0.84[95%置信区间,0.78-0.91])。14例患者(5%)经历了轻微的、自限性不良事件;未发生严重不良事件。
观察到的CT灌注和CT血管造影作为神经学标准判定死亡辅助检查的敏感性和特异性测量未达到预先设定的大于98%的验证阈值。临床检查仍然是神经学标准判定死亡的基石,在全面临床评估中应谨慎解释辅助成像结果。