Safety of moderate-to-deep sedation performed by sedation practitioners A national prospective observational study
Safety of moderate-to-deep sedation performed by sedation practitioners A national prospective observational study
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DOI：
10.1097/eja.0000000000000835
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发表时间：
2018-09-01
影响因子：
3.6
通讯作者：
Preckel, Benedikt
中科院分区：
文献类型：
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作者：
Koers, Lena;Eberl, Suzanne;Preckel, Benedikt
背景在荷兰，一个显着比例的中度至深度镇静是由镇静从业者的麻醉师的间接监督下进行，但有有限的安全性dataavailable.OBJECTIVE估计镇静相关的不良事件和患者相关outcomes（PRO）.DESIGN这是一个前瞻性的国家观察性研究。数据收集与修改的不良事件报告工具从国际镇静工作组的世界社会静脉麻醉。设置在荷兰的24家医院，其中中度至深度镇静是由镇静医生从2015年2月1日至2016年3月1日进行。患者进行中度至深度镇静的胃肠，干预观察：分析包括描述性统计和多变量逻辑回归模型，用于不良事件和PRO之间的关联。主要结局指标主要结局是不利PRO的发生率（入住ICU、永久性神经功能缺损、肺吸入或死亡）。次要结局是中度至良好PRO（计划外住院或护理升级）的发生率。复合结局是所有主要和次要结局的总和。结果共纳入11869例患者，中位年龄为64岁[四分位数范围为51 - 721]。阿萨身体评分分布为：第一，19.1%;第二，57.6%;第三，21.6%;第四，1.2%。1517例（12.8%）发生轻微不良事件，113例（1.0%）发生轻微不良事件，80例（0.7%）发生重大不良事件。主要结局：观察到5例（0.04%）不利PRO; 4例患者需要入住重症监护室; 1例死亡。次要结局：观察到12例（0.1%）中度至良好PRO。中度和主要不良事件与复合结果[3.7（95%置信区间1.1至11.9）和40.6（95%置信区间11.0至150.4）1，但不是最小或轻微的不良事件。结论中度至深度镇静由训练有素的镇静从业者进行了一个非常低的不利结果率。
BACKGROUND In the Netherlands, a significant proportion of moderate-to-deep sedation is performed by sedation practitioners under the indirect supervision of an anaesthesiologist but there are limited safety data available.OBJECTIVE To estimate the rate of sedation-related adverse events and patient relevant outcomes (PRO).DESIGN This was a prospective national observational study. Data were collected with a modified adverse event reporting tool from the International Sedation Task Force of the World Society of Intravenous Anaesthesia.SETTING A total of 24 hospitals in the Netherlands where moderate-to-deep sedation was performed by sedation practitioners from the 1 February 2015 to 1 March 2016.PATIENTS Consecutive adults undergoing moderate-to-deep sedation for gastrointestinal, pulmonary and cardiac procedures.INTERVENTION Observation: Analysis included descriptive statistics and a multivariate logistic regression model for an association between adverse events and PRO.MAIN OUTCOME MEASURES The primary outcome was the rate of unfavourable PRO (admission to ICU, permanent neurological deficit, pulmonary aspiration or death). Secondary outcome was the rate of moderate-to-good PRO (unplanned hospital admission or escalation of care). Composite outcome was the sum of all primary and secondary outcomes.RESULTS A total of 11 869 patients with a median age of 64 years [interquartile range 51 to 721 were included. ASA physical score distribution was: first, 19.1%; second, 57.6%; third, 21.6%; fourth, 1.2%. Minimal adverse events occurred in 1517 (12.8%), minor adverse events in 113 (1.0%) and major adverse events in 80 instances (0.7%). Primary outcome: Five (0.04%) unfavourable PRO were observed; four patients needing admission to the intensive care unit; and one died. Secondary outcome: 12 (0.1%) moderate-to-good PRO were observed. Moderate and major adverse events were associated with the composite outcome [3.7 (95% confidence interval 1.1 to 11.9) and 40.6 (95% confidence interval 11.0 to 150.4)1, but not minimal or minor adverse events.CONCLUSION Moderate-to-deep sedation performed by trained sedation practitioners has a very low rate of unfavourable outcome.