Right Ventricular Dysfunction in Ventilated Patients With COVID-19

• Conditions: ARDS; Right Ventricular Dysfunction; Covid19

• Registration Number: NCT04764032
• Lead Sponsor: University of Glasgow

Brief Summary

Using echocardiography to investigate the incidence of RV dysfunction in ventilated patients with COVID-19.

Detailed Description

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.

Study Timeline

• Study Start: 2020-09-02
• Status Verified: 2021-02
• Study First Submitted: 2021-02-12
• Study First Submitted QC: 2021-02-17
• Last Update Submitted: 2021-02-17
• Study First Posted: 2021-02-21
• Last Update Posted: 2021-02-21
• Primary Completion: 2021-03-31
• Study Completion: 2021-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Provision of informed consent.
• 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

• Pregnancy.
• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The prevalence of RV dysfunction in ventilated patients with COVID-19	Any timepoint from eligibility (ventilation for more than 48 hours) to 14 days following tracheal intubation and positive pressure ventilation.	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).
Association of RV dysfunction with 30-day mortality.	Up to 30-days following intubation and intermittent positive pressure ventilation

Secondary Outcome Measures

Name	Time	Method
The association of ventilation and RV dysfunction	At time of echocardiography
The association of direct myocardial injury and RV dysfunction	At time of echocardiography
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
Association of ARDS and RV dysfunction	At time of echocardiography
Association of ventilation and 30-day mortality	Up to 30-days following intubation and intermittent positive pressure ventilation
The difference in hsTn between patients with, and patients without, RV dysfunction.	At time of echocardiography
Association of micro/macro thrombi and RV dysfunction	At time of echocardiography
Association of micro/macro thrombi 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
Association of ARDS 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 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

Trial Locations

Locations (11)

Aberdeen Royal Infirmary; 🇬🇧 Aberdeen, United Kingdom

Golden Jubilee National Hospital; 🇬🇧 Clydebank, United Kingdom

University Hospital Hairmyres; 🇬🇧 East Kilbride, United Kingdom

Dumfries and Galloway Royal Infirmary; 🇬🇧 Dumfries, United Kingdom

Queen Elizabeth University Hospital; 🇬🇧 Glasgow, United Kingdom

Univeristy Hospital, Ayr; 🇬🇧 Ayr, United Kingdom

Glasgow Royal Infirmary; 🇬🇧 Glasgow, United Kingdom

Raigmore Hospital; 🇬🇧 Inverness, United Kingdom

Royal Alexandra hospital; 🇬🇧 Paisley, United Kingdom

University Hospital, Crosshouse; 🇬🇧 Kilmarnock, United Kingdom

University Hospital, Wishaw; 🇬🇧 Wishaw, United Kingdom