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在一项前瞻性多中心研究中,ccNexfin CO-trek 心输出量与间歇性冷弹丸肺热稀释法的一致性。

Agreement between ccNexfin CO-trek cardiac output and intermittent cold-bolus pulmonary thermodilution in a prospective multicenter study.

机构信息

Department of Anesthesiology, Academic Medical Center (AMC) Amsterdam, University of Amsterdam, Amsterdam, The Netherlands -

Department of Anesthesiology, Free University Medical Center, Amsterdam, The Netherlands.

出版信息

Minerva Anestesiol. 2018 Apr;84(4):473-480. doi: 10.23736/S0375-9393.17.12051-1. Epub 2017 Dec 13.

DOI:10.23736/S0375-9393.17.12051-1
PMID:29239149
Abstract

BACKGROUND

The ccNexfin System uses the CO-trek algorithm to analyze a non-invasively obtained arterial pressure waveform and calculate cardiac output (NEXCO). It remains matter of debate whether NEXCO can replace invasive, pulmonary artery catheter-derived, cold-bolus pulmonary thermodilution cardiac output measurement (PACCO). This study aimed at testing NEXCO-PACCO agreement in a large sample size, multicenter study. We hypothesized that agreement between NEXCO and PACCO would be demonstrated by a mean accuracy (bias) <0.6 L/min with a percentage error <30%.

METHODS

Patients undergoing cardiac surgery in three academic hospitals clinically requiring pulmonary artery catheterization were included. Exclusion criteria were aortic, pulmonary and tricuspid (valve) abnormalities, non-sinus rhythm and insufficient perfusion of the digits such as in Raynaud's disease. After induction of anesthesia, cardiac output was measured with four cold bolus thermodilution measurements and four averaged 30-second ccNexfin measurements randomized through the respiratory cycle to obtain one measurement pair. Mean accuracy and precision of ccNexfin were expressed as bias (mean of all NEXCO-PACCO differences) and limits of agreement (LOA) (1.96·SD of bias). Percentage error was calculated as [LOA / (NEXCO-PACCO average)].

RESULTS

Fifty-five patients were enrolled in the study, 51 completed the protocol. Median PACCO was 3.7 (IQR: 3.2 to 4.6) L/min and median NEXCO was 3.8 (IQR: 3.1 to 4.7) L/min. NEXCO-PACCO bias was 0.1 (LOA: -1.4 to +1.6) L/min with a 37% percentage error.

CONCLUSIONS

In this study, cardiac output measurement with ccNexfin failed to meet the predefined criteria for agreement with cold-bolus pulmonary artery thermodilution.

摘要

背景

ccNexfin 系统使用 CO-trek 算法分析非侵入性获得的动脉血压波形并计算心输出量(NEXCO)。NEXCO 是否可以替代有创、肺动脉导管热稀释心输出量测量(PACCO)仍然存在争议。本研究旨在一项大样本、多中心研究中检验 NEXCO 和 PACCO 的一致性。我们假设 NEXCO 和 PACCO 之间的一致性将通过平均准确性(偏差)<0.6 L/min 和误差百分比<30%来证明。

方法

纳入在三家学术医院接受心脏手术且临床需要肺动脉导管的患者。排除标准为主动脉、肺动脉和三尖瓣(瓣)异常、非窦性节律和手指灌注不足,如雷诺病。麻醉诱导后,通过四个冷弹丸热稀释测量和四个平均 30 秒 ccNexfin 测量,在呼吸周期中随机化以获得一个测量对,测量心输出量。ccNexfin 的平均准确性和精密度表示为偏差(所有 NEXCO-PACCO 差异的平均值)和界限(LOA)(偏差的 1.96·SD)。误差百分比计算为 [LOA /(NEXCO-PACCO 平均值)]。

结果

55 例患者纳入研究,51 例完成方案。中位 PACCO 为 3.7(IQR:3.2 至 4.6)L/min,中位 NEXCO 为 3.8(IQR:3.1 至 4.7)L/min。NEXCO-PACCO 偏差为 0.1(LOA:-1.4 至 +1.6)L/min,误差百分比为 37%。

结论

在这项研究中,ccNexfin 的心输出量测量未能满足与冷弹丸肺动脉热稀释法的一致性的预定标准。

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