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| Name | Class |
|---|---|
| Golden Jubilee National Hospital | OTHER_GOV |
| Robertson Centre for Biostatistics | UNKNOWN |
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Using echocardiography to investigate the incidence of RV dysfunction in ventilated patients with COVID-19.
INTRODUCTION Following the first reported cases in China, there has been a worldwide pandemic of a new virus commonly known as, Coronavirus. The virus causes a number of conditions including; cough, high temperature, painful muscles and breathing difficulties. The disease the virus causes is known as Coronavirus Disease 2019 (COVID-19). In the majority of cases these symptoms will get better without any treatment and without needing admission to hospital. In a small proportion of cases, the symptoms can be so bad that patients will need admission to hospital. Of the group admitted to hospital an even smaller group (approximately 5% of all confirmed coronavirus cases) will need treatment in an intensive care unit. This is often for severe breathing difficulties and sometimes requires the patient to be put on a breathing machine. The breathing machine is also known as a life support machine or ventilator and needing its support is known as 'ventilation' or 'being ventilated'.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Echocardiography | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The prevalence of RV dysfunction in ventilated patients with COVID-19 | RV dysfunction will be defined as Trans Thoracic Echo (TTE) evidence of RV dilatation along with the presence of septal flattening (in systole, diastole or both). | Any timepoint from eligibility (ventilation for more than 48 hours) to 14 days following tracheal intubation and positive pressure ventilation. |
| Association of RV dysfunction with 30-day mortality. | Up to 30-days following intubation and intermittent positive pressure ventilation |
| Measure | Description | Time Frame |
|---|---|---|
| Association of ARDS and RV dysfunction | At time of echocardiography | |
| Association of micro/macro thrombi and RV dysfunction | At time of echocardiography | |
| The association of direct myocardial injury and RV dysfunction |
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Inclusion Criteria:
Exclusion Criteria:
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Patients requiring tracheal intubation and intermittent positive pressure ventilation for COVID-19 in Scottish intensive care units
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ben Shelley, MD | Contact | 01419515000 | 4293 | benjamin.shelley@glasgow.ac.uk |
| Philip McCall, MD | Contact | 01419515000 | 4293 | philipmccall@nhs.net |
| Name | Affiliation | Role |
|---|---|---|
| Ben Shelley, MD | University of Glasgow | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aberdeen Royal Infirmary | Recruiting | Aberdeen | AB25 2ZN | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33441361 | Background | 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. | |
| 36370220 | Derived |
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| At time of echocardiography |
| The association of ventilation and RV dysfunction | At time of echocardiography |
| Association of ARDS and 30-day mortality | Up to 30-days following intubation and intermittent positive pressure ventilation |
| Association of micro/macro thrombi and 30-day mortality | Up to 30-days following intubation and intermittent positive pressure ventilation |
| Association of direct myocardial injury and 30-day mortality | Up to 30-days following intubation and intermittent positive pressure ventilation |
| Association of ventilation and 30-day mortality | Up to 30-days following intubation and intermittent positive pressure ventilation |
| The difference in NP levels between patients with, and patients without, RV dysfunction. | At time of echocardiography |
| The difference in hsTn between patients with, and patients without, RV dysfunction. | At time of echocardiography |
| Association between hsTn and 30-day mortality in patients with, and patients without, RV dysfunction | Up to 30-days following intubation and intermittent positive pressure ventilation |
| Association between NP levels and 30-day mortality in patients with, and patients without, RV dysfunction | Up to 30-days following intubation and intermittent positive pressure ventilation |
| Univeristy Hospital, Ayr | Recruiting | Ayr | KA6 6DX | United Kingdom |
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| Golden Jubilee National Hospital | Recruiting | Clydebank | United Kingdom |
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| Dumfries and Galloway Royal Infirmary | Recruiting | Dumfries | DG2 8RX | United Kingdom |
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| University Hospital Hairmyres | Recruiting | East Kilbride | G75 8RG | United Kingdom |
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| Queen Elizabeth University Hospital | Recruiting | Glasgow | G51 4TF | United Kingdom |
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| Glasgow Royal Infirmary | Recruiting | Glasgow | United Kingdom |
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| Raigmore Hospital | Recruiting | Inverness | IV2 3JH | United Kingdom |
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| University Hospital, Crosshouse | Recruiting | Kilmarnock | KA2 0BE | United Kingdom |
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| Royal Alexandra hospital | Recruiting | Paisley | PA2 9PJ | United Kingdom |
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| University Hospital, Wishaw | Recruiting | Wishaw | ML2 0DP | United Kingdom |
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| 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. |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D018497 | Ventricular Dysfunction, Right |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D018754 | Ventricular Dysfunction |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D004452 | Echocardiography |
| ID | Term |
|---|---|
| D057791 | Cardiac Imaging Techniques |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D014463 | Ultrasonography |
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
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