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院前急救医学中休克患者连续与间歇性无创血压测量的单中心前瞻性试点试验

Continuous versus intermittent noninvasive blood pressure measurement in patients with shock in prehospital emergency medicine - a single-center prospective pilot trial.

作者信息

Katzenschlager Stephan, Heck Raphael, Kaltschmidt Nikolai, Weilbacher Frank, Weigand Markus A, Popp Erik, Dietrich Maximilian

机构信息

Medical Faculty Heidelberg, Department of Anaesthesiology, Heidelberg University, Im Neuenheimer Feld 420, 69120, Heidelberg, Germany.

出版信息

Scand J Trauma Resusc Emerg Med. 2025 Aug 21;33(1):143. doi: 10.1186/s13049-025-01457-5.

Abstract

BACKGROUND

Shock is a critical and potentially life-threatening clinical state characterized by circulatory insufficiency and impaired micro- and macrocirculation. Rapid detection and initiation of therapy are essential for patient outcomes. In prehospital emergency medicine, assessment tools are limited, and intermittent noninvasive blood pressure (iNIBP) monitoring is the current standard of care. Recent findings suggest that this method may miss episodes of relevant hypotension. Continuous noninvasive blood pressure (cNIBP) and tissue oxygenation (StO) measurements could improve the time to detection of shock.

METHODS

This single-center prospective pilot trial compared a cNIBP system with standard iNIBP measurements in physician-staffed prehospital care. The study was conducted in the Rhine-Neckar region between May and December 2023. The Edwards HemoSphere system, including ClearSight for cNIBP and ForeSight for StO, was used in conjunction with standard monitoring. Adults with shock were eligible for inclusion. Primary endpoint was the agreement between cNIBP and iNIBP; secondary endpoints included unrecognized hypotension (MAP < 60 mmHg) and comparison between cNIBP/iNIBP and StO. Bland-Altman analysis quantified bias and limits of agreement (LoA).

RESULTS

In total, 25 patients were included, resulting in 100 simultaneous measurements. iNIBP readings exceeded cNIBP measurements of mean arterial pressure (MAP) by 10.77 mmHg (p < 0.01). There were further significant differences for systolic and diastolic blood pressure, with higher values for iNIBP measurements. Bland-Altman analysis demonstrated systemic bias (MAP bias - 10.25) with wide LoA (-43.52 to 22.21), indicating poor interchangeability. In three out of 25 cases, standard intermittent blood pressure measurements failed to detect hypotension, although cNIBP showed MAP values below 60 mmHg.

CONCLUSION

Our pilot data show cNIBP and iNIBP values differ significantly, with clinical implications, potentially improving hemodynamic instability detection. However, as this is preliminary, more research on system reliability and benefits of enhanced monitoring is needed.

TRIAL REGISTRATION

German Clinical Trials Registry (DRKS ID DRKS00031867) on 22.05.2023.

摘要

背景

休克是一种危急且可能危及生命的临床状态,其特征为循环功能不全以及微循环和大循环受损。快速检测并启动治疗对于患者的预后至关重要。在院前急救医学中,评估工具有限,间歇性无创血压(iNIBP)监测是当前的护理标准。最近的研究结果表明,这种方法可能会漏诊相关的低血压发作。连续无创血压(cNIBP)和组织氧合(StO)测量可能会缩短休克的检测时间。

方法

这项单中心前瞻性试点试验在配备医生的院前护理中,将cNIBP系统与标准iNIBP测量进行了比较。该研究于2023年5月至12月在莱茵-内卡地区进行。爱德华兹HemoSphere系统,包括用于cNIBP的ClearSight和用于StO的ForeSight,与标准监测设备联合使用。符合休克诊断的成年患者被纳入研究。主要终点是cNIBP与iNIBP之间的一致性;次要终点包括未被识别的低血压(平均动脉压<60 mmHg)以及cNIBP/iNIBP与StO之间的比较。Bland-Altman分析对偏差和一致性界限(LoA)进行了量化。

结果

总共纳入了25例患者,共进行了100次同步测量。iNIBP测得的平均动脉压(MAP)读数比cNIBP测量值高10.77 mmHg(p<0.01)。收缩压和舒张压也存在进一步的显著差异,iNIBP测量值更高。Bland-Altman分析显示存在系统性偏差(MAP偏差为-10.25),一致性界限较宽(-43.52至22.21),表明互换性较差。在25例病例中有3例,标准间歇性血压测量未能检测到低血压,而cNIBP显示MAP值低于60 mmHg。

结论

我们的试点数据表明,cNIBP和iNIBP值存在显著差异,具有临床意义,可能会改善对血流动力学不稳定的检测。然而,由于这是初步研究,需要对系统可靠性和强化监测的益处进行更多研究。

试验注册

德国临床试验注册中心(DRKS ID DRKS00031867),于2023年5月22日注册。

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