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)
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 incor...
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2020-09-01
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| author | Steven J R Meex Walther N K A van Mook Iwan C C van der Horst Jeanette Tas Coen D A Stehouwer 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 Otto Bekers Astrid M L Oude Lashof Fabian H Tijssen Jan-Willem E M Sels Chahinda Ghossein-Doha Rob G H Driessen Pieter L Kubben Marcus L F Janssen Gerry A F Nicolaes Ulrich Strauch Zafer Geyik Thijs S R Delnoij Kim H M Walraven Jeanine A M C F Verbunt Susanne van Santen Ronny M Schnabel Marcel J H Aries Marcel C G van de Poll Bas C T van Bussel Joachim E Wildberger Sander M J van Kuijk Dennis C J J Bergmans Paul H M Savelkoul Alma M A Mingels Wolfgang F F A Buhre |
| author_facet | Steven J R Meex Walther N K A van Mook Iwan C C van der Horst Jeanette Tas Coen D A Stehouwer 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 Otto Bekers Astrid M L Oude Lashof Fabian H Tijssen Jan-Willem E M Sels Chahinda Ghossein-Doha Rob G H Driessen Pieter L Kubben Marcus L F Janssen Gerry A F Nicolaes Ulrich Strauch Zafer Geyik Thijs S R Delnoij Kim H M Walraven Jeanine A M C F Verbunt Susanne van Santen Ronny M Schnabel Marcel J H Aries Marcel C G van de Poll Bas C T van Bussel Joachim E Wildberger Sander M J van Kuijk Dennis C J J Bergmans Paul H M Savelkoul Alma M A Mingels Wolfgang F F A Buhre |
| author_sort | Steven J R Meex |
| collection | DOAJ |
| description | 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). |
| format | Article |
| id | doaj-art-df4fe93b9c7b4d75bb5842808cbe9919 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2020-09-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-df4fe93b9c7b4d75bb5842808cbe99192025-01-08T11:30:09ZengBMJ Publishing GroupBMJ Open2044-60552020-09-0110910.1136/bmjopen-2020-040175Serial measurements in COVID-19-induced acute respiratory disease to unravel heterogeneity of the disease course: design of the Maastricht Intensive Care COVID cohort (MaastrICCht)Steven J R Meex0Walther N K A van Mook1Iwan C C van der Horst2Jeanette Tas3Coen D A Stehouwer4Rob J J van Gassel5Serge J H Heines6Mark M G Mulder7Nanon F L Heijnen8Melanie J Acampo-de Jong9Julia L M Bels10Frank C Bennis11Marcel Koelmann12Rald V M Groven13Moniek A Donkers14Frank van Rosmalen15Ben J M Hermans16Otto Bekers17Astrid M L Oude Lashof18Fabian H Tijssen19Jan-Willem E M Sels20Chahinda Ghossein-Doha21Rob G H Driessen22Pieter L Kubben23Marcus L F Janssen24Gerry A F Nicolaes25Ulrich Strauch26Zafer Geyik27Thijs S R Delnoij28Kim H M Walraven29Jeanine A M C F Verbunt30Susanne van Santen31Ronny M Schnabel32Marcel J H Aries33Marcel C G van de Poll34Bas C T van Bussel35Joachim E Wildberger36Sander M J van Kuijk37Dennis C J J Bergmans38Paul H M Savelkoul39Alma M A Mingels40Wolfgang F F A Buhre41Central Diagnostic Laboratory, Clinical Chemistry, Maastricht UMC+, Maastricht, The NetherlandsSchool of Health Professions Education, Maastricht University, Maastricht, The NetherlandsIntensive Care, Maastricht University Medical Center+, Maastricht, The Netherlands4 Intensive Care, Maastricht Universitair Medisch Centrum+, Maastricht, The NetherlandsMaastricht University Medical Centre, Maastricht, NetherlandsDepartment of Intensive Care, Maastricht University Medical Center+, Maastricht, The NetherlandsDepartment of Intensive Care, Maastricht University Medical Center+, Maastricht, The NetherlandsDepartment of Intensive Care, Maastricht University Medical Center+, Maastricht, The NetherlandsDepartment of Intensive Care, Maastricht University Medical Center+, Maastricht, The NetherlandsDepartment of Intensive Care, Maastricht University Medical Center+, Maastricht, The NetherlandsDepartment of Intensive Care, Maastricht University Medical Center+, Maastricht, The Netherlands4 Computer Science, Vrije Universiteit Amsterdam, Amsterdam, NetherlandsDepartment of Intensive Care, Maastricht University Medical Center+, Maastricht, The NetherlandsDepartment of Intensive Care, Maastricht University Medical Center+, Maastricht, The NetherlandsDepartment of Intensive Care, Maastricht University Medical Center+, Maastricht, The NetherlandsDepartment of Intensive Care, Maastricht University Medical Centre+, Maastricht, The NetherlandsDepartment of Intensive Care, Maastricht University Medical Center+, Maastricht, The NetherlandsCARIM Cardiovascular Research Institute, Maastricht University, Maastricht, The NetherlandsDepartment of Medical Microbiology, Maastricht University Medical Centre+, Maastricht, The NetherlandsDepartment of Anesthesiology, Maastricht University Medical Center+, Maastricht, The NetherlandsDepartment of Intensive Care, Maastricht University Medical Center+, Maastricht, The NetherlandsSchool for Cardiovascular Diseases (CARIM), Maastricht University, Maastricht, The NetherlandsDepartment of Intensive Care, Maastricht University Medical Center+, Maastricht, The NetherlandsDepartment of Neurosurgery, Maastricht University Medical Centre+, Maastricht, The NetherlandsDepartment of Clinical Neurophysiology, Maastricht University Medical Centre+, Maastricht, The NetherlandsDepartment of Biochemistry, Maastricht University Medical Center+, Maastricht, The NetherlandsDepartment of Intensive Care Medicine, Maastricht University Medical Centre+, Maastricht, The NetherlandsDepartment of Intensive Care, Maastricht University Medical Center+, Maastricht, The NetherlandsDepartment of Intensive Care, Maastricht University Medical Center+, Maastricht, The NetherlandsDepartment of Pulmonology, Maastricht University Medical Center+, Maastricht, The NetherlandsDepartment of Rehabilitation Medicine, Maastricht University Medical Centre+, Maastricht, The NetherlandsDepartment of Intensice Care, Maastricht Universitair Medisch Centrum+, Maastricht, The NetherlandsDepartment of Intensive Care, Maastricht University Medical Center+, Maastricht, The NetherlandsDepartment of Intensive Care, Maastricht Universitair Medisch Centrum+, Maastricht, The NetherlandsDepartment of Intensive Care, Maastricht University Medical Center+, Maastricht, The Netherlandsmedical doctor3 Department of Radiology and Nuclear Medicine, Maastricht University Medical Centre+, Maastricht, Limburg, The NetherlandsDepartment of Clinical Epidemiology and Medical Technology Assessments, Maastricht University Medical Centre, Maastricht, The Netherlands7 Intensive Care, Maastricht Universitair Medisch Centrum+, Maastricht, NetherlandsDepartment of Medical Microbiology and Infection Control, VU University Medical Center, De Boelelaan, Amsterdam, The NetherlandsCentral Diagnostic Laboratory, Maastricht University Medical Centre+, Maastricht, NetherlandsDepartment of Anesthesiology, Maastricht University Medical Center+, Maastricht, The NetherlandsIntroduction 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).https://bmjopen.bmj.com/content/10/9/e040175.full |
| spellingShingle | Steven J R Meex Walther N K A van Mook Iwan C C van der Horst Jeanette Tas Coen D A Stehouwer 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 Otto Bekers Astrid M L Oude Lashof Fabian H Tijssen Jan-Willem E M Sels Chahinda Ghossein-Doha Rob G H Driessen Pieter L Kubben Marcus L F Janssen Gerry A F Nicolaes Ulrich Strauch Zafer Geyik Thijs S R Delnoij Kim H M Walraven Jeanine A M C F Verbunt Susanne van Santen Ronny M Schnabel Marcel J H Aries Marcel C G van de Poll Bas C T van Bussel Joachim E Wildberger Sander M J van Kuijk Dennis C J J Bergmans Paul H M Savelkoul Alma M A Mingels Wolfgang F F A Buhre 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) BMJ Open |
| 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) |
| title_full | 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_fullStr | 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_full_unstemmed | 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_short | 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_sort | 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 |
| url | https://bmjopen.bmj.com/content/10/9/e040175.full |
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