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Title of the item:

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)

Title:
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)
Authors:
Joachim Wildberger
Jeanette Tas
Rob J J van Gassel
Serge J H Heines
Mark M G Mulder
Nanon F L Heijnen
Melanie J Acampo-de Jong
Julia L M Bels
Frank C Bennis
Marcel Koelmann
Rald V M Groven
Moniek A Donkers
Frank van Rosmalen
Ben J M Hermans
Steven JR Meex
Alma Mingels
Otto Bekers
Paul Savelkoul
Astrid M L Oude Lashof
Fabian H Tijssen
Wolfgang Buhre
Jan-Willem E M Sels
Chahinda Ghossein-Doha
Rob G H Driessen
Pieter L Kubben
Gerry A F Nicolaes
Ulrich Strauch
Zafer Geyik
Thijs S R Delnoij
Kim H M Walraven
Coen DA Stehouwer
Jeanine A M C F Verbunt
Walther N.K.A Van Mook
Susanne van Santen
Ronny M Schnabel
Marcel C G van de Poll
Dennis Bergmans
Sander van Kuijk
Bas C T van Bussel
Subject Terms:
Medicine
Source:
BMJ Open, Vol 10, Iss 9 (2020)
Publisher:
BMJ Publishing Group, 2020.
Publication Year:
2020
Collection:
LCC:Medicine
Document Type:
article
File Description:
electronic resource
Language:
English
ISSN:
2044-6055
Relation:
https://bmjopen.bmj.com/content/10/9/e040175.full; https://doaj.org/toc/2044-6055
DOI:
10.1136/bmjopen-2020-040175
Access URL:
https://doaj.org/article/df4fe93b9c7b4d75bb5842808cbe9919  Link opens in a new window
Accession Number:
edsdoj.f4fe93b9c7b4d75bb5842808cbe9919
Academic Journal
Introduction 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.Methods and analysis 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.Ethics and dissemination 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.Trial registration number The Netherlands Trial Register (NL8613).

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