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新型 Capiox NX19 成人氧合器的临床评估——一项多中心研究。

Clinical evaluation of the novel Capiox NX19 adult oxygenator-a multicenter study.

机构信息

Department of Cardiothoraxic Surgery, Maastricht University Medical Centre, Maastricht, Netherlands.

Department of Extra-corporeal Circulation, University Hospital Antwerp, Edegem, Belgium.

出版信息

Perfusion. 2023 May;38(4):734-739. doi: 10.1177/02676591221078942. Epub 2022 Mar 29.

DOI:10.1177/02676591221078942
PMID:35348392
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10102914/
Abstract

INTRODUCTION

The novel Capiox NX19 adult oxygenator is, compared to its predecessors, improved with enhanced air removal technology, a polymer heat exchanger and smaller, innovative hollow fibers resulting in a surface area reduction and a lower priming volume. The aim of this study was to evaluate the NX19 oxygenator performance in a clinical setting.

METHODS

A prospective multicenter study was performed involving three large European university hospitals. The Capiox NX19 ( = 150) performance was assessed during adult cardiopulmonary bypass and involved gaseous microemboli handling and gas transfer efficiency. The heat exchanger performance was evaluated separately in vitro.

RESULTS

The heat exchanger performance factors were 0.80 ± 0.03 and 0.58 ± 0.04 at pump flow rates of 3 L/min and 6 L/min, respectively. After priming, residual post-oxygenator gaseous microemboli count and volume were decreased by 91% and 93.7%, respectively. The gas compartment pressure was 6.0 ± 2.5 mmHg, while the O transfer was 69 ± 30 mL/min/m and the CO transfer 73 ± 34 mL/min/m. The O gradient was 44 ± 19 mmHg/LPM and the O diffusing capacity 0.38 ± 0.14 mL/min/mmHg. The shunt fraction was 0.19 ± 0.13, whereas oxygenator resistance and shear stress were 10.5 ± 3.7 mmHg/LPM and 5.1 ± 3.1 dyn/cm, respectively.

CONCLUSION

This multicenter study displayed good clinical safety and performance of the NX19 oxygenator.

摘要

简介

新型 Capiox NX19 成人氧合器与前代产品相比,改进了空气去除技术、聚合物热交换器以及更小、创新的空心纤维,从而降低了表面积和预充量。本研究旨在评估 NX19 氧合器在临床环境中的性能。

方法

这是一项前瞻性多中心研究,涉及三家大型欧洲大学医院。在成人体外循环中评估了 Capiox NX19(n = 150)的性能,包括处理气态微栓和气体转移效率。分别在体外评估热交换器的性能。

结果

热交换器性能系数分别为 3 L/min 和 6 L/min 时的 0.80 ± 0.03 和 0.58 ± 0.04。预充后,后氧合器残余气态微栓计数和体积分别减少了 91%和 93.7%。气腔压力为 6.0 ± 2.5 mmHg,O 转移为 69 ± 30 mL/min/m,CO 转移为 73 ± 34 mL/min/m。O 梯度为 44 ± 19 mmHg/LPM,O 弥散能力为 0.38 ± 0.14 mL/min/mmHg。分流分数为 0.19 ± 0.13,而氧合器阻力和切应力分别为 10.5 ± 3.7 mmHg/LPM 和 5.1 ± 3.1 dyn/cm。

结论

这项多中心研究显示了 NX19 氧合器良好的临床安全性和性能。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bf6a/10102914/b9b31802ee7b/10.1177_02676591221078942-fig2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bf6a/10102914/a50cef34448e/10.1177_02676591221078942-fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bf6a/10102914/b9b31802ee7b/10.1177_02676591221078942-fig2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bf6a/10102914/a50cef34448e/10.1177_02676591221078942-fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bf6a/10102914/b9b31802ee7b/10.1177_02676591221078942-fig2.jpg

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