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护士主导与医生主导的院际重症监护转运:一项随机非劣效性试验。

Nurses versus physician-led interhospital critical care transport: a randomized non-inferiority trial.

作者信息

van Lieshout Erik Jan, Binnekade Jan, Reussien Elmer, Dongelmans Dave, Juffermans Nicole P, de Haan Rob J, Schultz Marcus J, Vroom Margreeth B

机构信息

Academic Medical Centre, Department of Intensive Care and Mobile Intensive Care Unit, University of Amsterdam, G3-206, 22700, 1100 DE, Amsterdam, The Netherlands.

Academic Medical Centre, Clinical Research Unit, University of Amsterdam, Amsterdam, The Netherlands.

出版信息

Intensive Care Med. 2016 Jul;42(7):1146-54. doi: 10.1007/s00134-016-4355-y. Epub 2016 May 11.

Abstract

PURPOSE

Regionalization and concentration of critical care increases the need for interhospital transport. However, optimal staffing of ground critical care transport has not been evaluated.

METHODS

In this prospective, randomized, open-label, blinded-endpoint non-inferiority trial, critically ill patients on mechanical ventilation transported by interhospital ground critical care transport were randomized between transport staffed by a dedicated team comprising a critical care nurse and paramedic (nurses group) or a dedicated team including a critical care physician (nurses + physician group). The primary outcome was the number of patients with critical events, both clinical and technical, during transport. Clinical events included decrease in blood pressure, oxygen saturation, or temperature, blood loss, new cardiac arrhythmias, or death. Non-inferiority was assumed if the upper limit of the two-sided 90 % confidence interval (CI) for the between-group difference lies below the non-inferiority margin of 3 %.

RESULTS

Of 618 eligible transported critically ill patients, 298 could be analyzed after randomization and allocation to the nurses group (n = 147) or nurses + physician group (n = 151). The percentages of patients with critical events were 16.3 % (24 incidents in 147 transports) in the nurses group and 15.2 % (23 incidents in 151 transports) in the nurses + physician group (difference 1.1 %, two-sided 90 % CI [-5.9 to 8.1]). Critical events occurred in both groups at a higher than the expected (0-1 %) rate. In the nurses group consultations for physician assistance were requested in 8.2 % (12 in 147 transports), all of which were performed prior to transport.

CONCLUSIONS

The number of patients with critical events did not markedly differ between critical care transports staffed by a critical care nurse and paramedic compared to a team including a critical care physician. However, as a result of an unexpected higher rate of critical events in both groups recorded by an electronic health record, non-inferiority of nurse-led interhospital critical transport could not be established ( http://www.controlled-trials.com/ISRCTN39701540 ).

摘要

目的

重症监护的区域化和集中化增加了医院间转运的需求。然而,地面重症监护转运的最佳人员配置尚未得到评估。

方法

在这项前瞻性、随机、开放标签、盲终点非劣效性试验中,通过医院间地面重症监护转运进行机械通气的重症患者被随机分配到由一名重症护理护士和一名护理人员组成的专门团队(护士组)或包括一名重症医生的专门团队(护士 + 医生组)进行转运。主要结局是转运期间发生临床和技术关键事件的患者数量。临床事件包括血压、血氧饱和度或体温下降、失血、新出现的心律失常或死亡。如果组间差异的双侧90%置信区间(CI)的上限低于3%的非劣效界值,则认为具有非劣效性。

结果

在618例符合条件的转运重症患者中,298例在随机分组并分配到护士组(n = 147)或护士 + 医生组(n = 151)后可进行分析。护士组发生关键事件的患者百分比为16.3%(147次转运中有24起事件),护士 + 医生组为15.2%(151次转运中有23起事件)(差异1.1%,双侧90%CI [-5.9至8.1])。两组中关键事件的发生率均高于预期(0 - 1%)。在护士组中,8.2%(147次转运中有12次)请求医生协助会诊,所有会诊均在转运前进行。

结论

与包括重症医生的团队相比,由重症护理护士和护理人员组成的重症监护转运中发生关键事件的患者数量没有明显差异。然而,由于电子健康记录显示两组中关键事件的发生率意外高于预期,因此无法确定由护士主导的医院间重症转运具有非劣效性(http://www.controlled-trials.com/ISRCTN39701540)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ec55/4879164/3cdd7f0c62fe/134_2016_4355_Fig1_HTML.jpg

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