Right Ventricular Dysfunction in Ventilated Patients With COVID-19
NCT ID: NCT04764032
Last Updated: 2021-02-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
150 participants
OBSERVATIONAL
2020-09-02
2021-04-30
Brief Summary
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Detailed Description
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In other conditions causing severe breathing difficulties requiring ventilation, pressure can be put on the right side of the heart ('the right heart \[or right ventricle\];' the part of the heart pumping blood to the lungs). This can cause the right heart to fail, struggling to pump blood forward and with a build-up of back pressure. This is also known as right heart (or ventricular) dysfunction. Patients needing ventilated, who develop problems with the right heart, are less likely to survive their intensive care stay. No scientists have examined whether patients with COVID-19, requiring ventilation, have problems with their right heart.
METHODS Using noninvasive ultrasound scans of the heart (echocardiography) the investigators will explore whether ventilated patients in intensive care have problems with their right heart. The investigators will also collect blood samples to look for damage to the heart during this time.
AIMS The aim of this study is to determine how many patients with COVID-19 needing ventilation have problems with the right heart. The investigators will explore if those patients with right heart problems are more likely to die by 30 days following their intensive care admission. By examining clinical data, the investigators will also look to see if any other conditions or treatments increase the risk of right heart problems. By identifying right heart problems in these patients, the investigators may be able to guide future studies to determine if any specific treatments targeted at protecting the right heart can improve outcomes in this patient group.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Echocardiography
Echocardiography will be undertaken by a range of appropriately competent practitioners including; intensive care clinicians, cardiologists and specialist echocardiographers. Imaging obtained will be in keeping with the protocol required for a Focused Intensive Care Echo (FICE) scan and should include ECG monitoring at all times. A focused dataset will be used to answer the primary outcome. If available and the echocardiographers competency and experience permit, further measures of RV function will be obtained at this time.
Eligibility Criteria
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Inclusion Criteria
* Age \> 16 years.
* Confirmed SARS-CoV-2 infection with severe acute respiratory failure requiring tracheal intubation and positive pressure ventilation in intensive care for more than 48 hours.
Exclusion Criteria
* Ongoing participation in any investigational research that may undermine the scientific basis of the study.
* Prior participation in the COVID-RV study.
* Ventilated for less than 48 hours prior to study recruitment.
* Those patients requiring extra-corporeal life support for respiratory or cardiovascular failure (veno-venous \[VV\] or veno-arterial \[VA\] extra-corporeal membrane oxygenation \[ECMO\]).
* Patient where end of life care has been instituted and they are not expected to survive for the next 24 hours.
17 Years
ALL
No
Sponsors
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Golden Jubilee National Hospital
OTHER_GOV
Robertson Centre for Biostatistics
UNKNOWN
University of Glasgow
OTHER
Responsible Party
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Dr Ben Shelley
Honorary Clinical Associate Professor
Principal Investigators
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Ben Shelley, MD
Role: STUDY_DIRECTOR
University of Glasgow
Locations
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Aberdeen Royal Infirmary
Aberdeen, , United Kingdom
Univeristy Hospital, Ayr
Ayr, , United Kingdom
Golden Jubilee National Hospital
Clydebank, , United Kingdom
Dumfries and Galloway Royal Infirmary
Dumfries, , United Kingdom
University Hospital Hairmyres
East Kilbride, , United Kingdom
Queen Elizabeth University Hospital
Glasgow, , United Kingdom
Glasgow Royal Infirmary
Glasgow, , United Kingdom
Raigmore Hospital
Inverness, , United Kingdom
University Hospital, Crosshouse
Kilmarnock, , United Kingdom
Royal Alexandra hospital
Paisley, , United Kingdom
University Hospital, Wishaw
Wishaw, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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James MacBrayne
Role: primary
Derek McLaughlan
Role: primary
Alexander McDonald
Role: primary
Nina Tatarkowska, MBChB
Role: primary
Malcolm Sim, MD
Role: primary
Alex Puxty, MBChB
Role: primary
Benjamin Greatorex
Role: primary
John Allan
Role: primary
Lisa Gemmell, MBChB
Role: primary
Dominic Strachan, MBChB
Role: primary
References
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Willder JM, McCall P, Messow CM, Gillies M, Berry C, Shelley B. Study protocol for COVID-RV: a multicentre prospective observational cohort study of right ventricular dysfunction in ventilated patients with COVID-19. BMJ Open. 2021 Jan 13;11(1):e042098. doi: 10.1136/bmjopen-2020-042098.
McErlane J, McCall P, Willder J, Berry C, Shelley B; COVID-RV investigators. Right ventricular free wall longitudinal strain is independently associated with mortality in mechanically ventilated patients with COVID-19. Ann Intensive Care. 2022 Nov 12;12(1):104. doi: 10.1186/s13613-022-01077-7.
Other Identifiers
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20/COVID/17
Identifier Type: -
Identifier Source: org_study_id
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