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The Inadequacy of Regulatory Frameworks in Time of Crisis and in Low-Resource Settings: Personal Protective Equipment and COVID-19.危机时期和资源匮乏环境下监管框架的不足:个人防护装备与新冠疫情
Health Technol (Berl). 2020;10(6):1375-1383. doi: 10.1007/s12553-020-00429-2. Epub 2020 May 2.
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SIAARTI recommendations for the allocation of intensive care treatments in exceptional, resource-limited circumstances.SIAARTI关于在特殊的、资源有限的情况下分配重症监护治疗的建议。
Minerva Anestesiol. 2020 May;86(5):469-472. doi: 10.23736/S0375-9393.20.14619-4. Epub 2020 Apr 3.
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The outbreak of Coronavirus Disease 2019 (COVID-19)-An emerging global health threat.2019 年冠状病毒病(COVID-19)爆发-新兴的全球健康威胁。
J Infect Public Health. 2020 Apr;13(4):644-646. doi: 10.1016/j.jiph.2020.02.033. Epub 2020 Mar 19.
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Clinical Characteristics of Coronavirus Disease 2019 in China.《中国 2019 年冠状病毒病临床特征》
N Engl J Med. 2020 Apr 30;382(18):1708-1720. doi: 10.1056/NEJMoa2002032. Epub 2020 Feb 28.
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A Novel Coronavirus from Patients with Pneumonia in China, 2019.2019 年中国肺炎患者中的一种新型冠状病毒。
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新型冠状病毒肺炎(COVID-19)危重症患者呼吸机的临床需求与技术要求:成人与儿童的循证比较

Clinical needs and technical requirements for ventilators for COVID-19 treatment critical patients: an evidence-based comparison for adult and pediatric age.

作者信息

Andellini Martina, De Santis Simone, Nocchi Federico, Bassanelli Elena, Pecchia Leandro, Ritrovato Matteo

机构信息

HTA Unit, Bambino Gesù Children's Hospital, Viale di Villa Pamphili 100, 00152 Rome, Italy.

School of Engineering, University of Warwick, Coventry, CV4 7AL UK.

出版信息

Health Technol (Berl). 2020;10(6):1403-1411. doi: 10.1007/s12553-020-00467-w. Epub 2020 Jul 30.

DOI:10.1007/s12553-020-00467-w
PMID:32837809
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7392366/
Abstract

The spread of severe acute respiratory syndrome coronavirus 2, taking on pandemic proportions, is placing extraordinary and unprecedented demands on healthcare systems worldwide. The increasing number of critical patients who, experiencing respiratory failure from acute respiratory distress syndrome, need respiratory support, has been leading countries to race against time in arranging new Intensive Care Units (ICUs) and in finding affordable and practical solutions to manage patients in each stage of the disease. The simultaneous worldwide emergency caused serious problems for mechanical ventilators supply. This chaotic scenario generated, indeed, a frenetic race to buy life-saving ventilators. However, the variety of mechanical ventilators designs, together with the limitations in time and resources, make the decision-making processes on ventilators procurement crucial and not counterbalanced by the evaluation of devices quality. This paper aimed at offering an overview of how evidence-based approach for health technologies evaluation, might provide support during Corona Virus Disease 2019 (COVID-19) pandemic in ICUs management and critical equipment supply. We compared and combined all the publicly available indications on the essential requirements that ICU ventilators might meet to be considered acceptable for treating COVID-19 patients in severe to critical illnesses. We hope that the critical analysis of these data might help readers to understand how structured decision-making processes based on evidence, evaluating the safety and effectiveness of a given medical device and the effects of its introduction in a healthcare setting, are able to optimize time and resources allocation that should be considered essential, especially during pandemic period.

摘要

严重急性呼吸综合征冠状病毒2的传播已呈大流行之势,给全球医疗系统带来了超乎寻常且前所未有的需求。越来越多的重症患者因急性呼吸窘迫综合征而出现呼吸衰竭,需要呼吸支持,这使得各国争分夺秒地安排新的重症监护病房(ICU),并寻找经济实惠且切实可行的方案来管理疾病各阶段的患者。全球同时出现的紧急情况给机械通气设备的供应带来了严重问题。这种混乱局面确实引发了一场抢购救命呼吸机的疯狂竞赛。然而,机械通气设备设计的多样性,加上时间和资源的限制,使得呼吸机采购的决策过程至关重要,且无法通过对设备质量的评估来平衡。本文旨在概述基于证据的卫生技术评估方法如何在2019冠状病毒病(COVID-19)大流行期间为ICU管理和关键设备供应提供支持。我们比较并整合了所有公开可用的关于ICU呼吸机为治疗重症至危重症COVID-19患者而可能满足的基本要求的指征。我们希望对这些数据的批判性分析能帮助读者理解基于证据的结构化决策过程如何评估特定医疗设备的安全性和有效性及其引入医疗环境后的影响,从而优化时间和资源分配,而这在大流行期间应被视为至关重要。