Serial measurements in COVID-19-induced acute respiratory disease to unravel heterogeneity of the disease course: design of the Maastricht Intensive Care COVID cohort (MaastrICCht).
Serial measurements in COVID-19-induced acute respiratory disease to unravel heterogeneity of the disease course: design of the Maastricht Intensive Care COVID cohort (MaastrICCht).
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DOI：
10.1136/bmjopen-2020-040175
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发表时间：
2020-09-29
期刊：
影响因子：
2.9
通讯作者：
van Bussel BCT
中科院分区：
文献类型：
--
作者：
Tas J;van Gassel RJJ;Heines SJH;Mulder MMG;Heijnen NFL;Acampo-de Jong MJ;Bels JLM;Bennis FC;Koelmann M;Groven RVM;Donkers MA;van Rosmalen F;Hermans BJM;Meex SJ;Mingels A;Bekers O;Savelkoul P;Oude Lashof AML;Wildberger J;Tijssen FH;Buhre W;Sels JEM;Ghossein-Doha C;Driessen RGH;Kubben PL;Janssen MLF;Nicolaes GAF;Strauch U;Geyik Z;Delnoij TSR;Walraven KHM;Stehouwer CD;Verbunt JAMCF;Van Mook WNKA;van Santen S;Schnabel RM;Aries MJH;van de Poll MCG;Bergmans D;van der Horst ICC;van Kuijk S;van Bussel BCT
机械通气患者中SARS-CoV-2感染的病程尚不清楚。为了揭示这些患者中SARS-CoV-2感染的临床异质性，我们设计了前瞻性观察性马斯特里赫特重症监护COVID队列（MaastrICCht）。我们纳入了一系列的测量，港口病因，诊断和预测信息。该研究旨在调查SARS-CoV-2感染重症患者自然病程的异质性。将纳入因SARS-CoV-2感染而进入重症监护室的机械通气患者。我们将收集临床变量、生命参数、实验室变量、机械呼吸机设置、胸部电阻抗断层扫描、ECG、超声心动图以及其他成像方式，以评估重症患者SARS-CoV-2感染过程的异质性。MaastrICCht还旨在促进各种其他研究和登记，并打算为调查人员创建一个开放源码数据库。因此，数据收集的主要部分与现有的国家重症监护数据登记处和两个国际COVID-19数据收集计划保持一致。此外，我们创建了一个灵活的设计，以便在正在进行的研究中，根据从快速增长的证据中获得的新知识，可以添加额外的措施。COVID-19大流行的传播需要迅速实施观察性研究，以揭示SARS-CoV-2感染在机械通气患者中自然病程的异质性。我们的研究设计有望提高对该疾病的病因学、诊断和预后的理解。本文介绍了MaastrICCht的设计。已获得马斯特里赫特大学医学中心+（马斯特里赫特UMC+）医学伦理委员会（Medisch Ethische Toetsingscommissie 2020-1565/3 00 523）的伦理批准，将根据赫尔辛基宣言进行。于疫情期间，马斯特里赫特UMC+董事会采纳一项政策，告知患者并征求其同意使用所收集的数据，并储存血清样本以供COVID-19研究之用。所有研究文件将在最后一例患者入组后安全保存15年。研究结果将发表在同行评审的学术期刊上，优先考虑开放获取期刊，同时特别考虑尽早将手稿存放在预印本服务器上。荷兰试验登记册（NL 8613）。
The course of the disease in SARS-CoV-2 infection in mechanically ventilated patients is unknown. To unravel the clinical heterogeneity of the SARS-CoV-2 infection in these patients, we designed the prospective observational Maastricht Intensive Care COVID cohort (MaastrICCht). We incorporated serial measurements that harbour aetiological, diagnostic and predictive information. The study aims to investigate the heterogeneity of the natural course of critically ill patients with a SARS-CoV-2 infection. Mechanically ventilated patients admitted to the intensive care with a SARS-CoV-2 infection will be included. We will collect clinical variables, vital parameters, laboratory variables, mechanical ventilator settings, chest electrical impedance tomography, ECGs, echocardiography as well as other imaging modalities to assess heterogeneity of the course of a SARS-CoV-2 infection in critically ill patients. The MaastrICCht is also designed to foster various other studies and registries and intends to create an open-source database for investigators. Therefore, a major part of the data collection is aligned with an existing national intensive care data registry and two international COVID-19 data collection initiatives. Additionally, we create a flexible design, so that additional measures can be added during the ongoing study based on new knowledge obtained from the rapidly growing body of evidence. The spread of the COVID-19 pandemic requires the swift implementation of observational research to unravel heterogeneity of the natural course of the disease of SARS-CoV-2 infection in mechanically ventilated patients. Our study design is expected to enhance aetiological, diagnostic and prognostic understanding of the disease. This paper describes the design of the MaastrICCht. Ethical approval has been obtained from the medical ethics committee (Medisch Ethische Toetsingscommissie 2020-1565/3 00 523) of the Maastricht University Medical Centre+ (Maastricht UMC+), which will be performed based on the Declaration of Helsinki. During the pandemic, the board of directors of Maastricht UMC+ adopted a policy to inform patients and ask their consent to use the collected data and to store serum samples for COVID-19 research purposes. All study documentation will be stored securely for fifteen years after recruitment of the last patient. The results will be published in peer-reviewed academic journals, with a preference for open access journals, while particularly considering deposition of the manuscripts on a preprint server early. The Netherlands Trial Register (NL8613).
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影响因子：
24.3
作者：
Guan, Wei-jie;Liang, Wen-hua;He, Jian-xing
通讯作者：
He, Jian-xing
DOI：
10.23736/s1973-9087.20.06305-4
发表时间：
2020-06-01
影响因子：
4.5
作者：
Kiekens, Carlotte;Boldrini, Paolo;Negrini, Stefano
通讯作者：
Negrini, Stefano
影响因子：
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作者：
Klok, F. A.;Kruip, M. J. H. A.;Endeman, H.
通讯作者：
Endeman, H.
影响因子：
3.1
作者：
Lorusso, Roberto;Alexander, Peta;Barbaro, Ryan
通讯作者：
Barbaro, Ryan
影响因子：
2.2
作者：
Heines SJH;Strauch U;van de Poll MCG;Roekaerts PMHJ;Bergmans DCJJ
通讯作者：
Bergmans DCJJ