Right Ventricular Dysfunction in Ventilated Patients With COVID-19 (COVID-RV)

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

Study Overview

• Status: Recruiting
• Conditions: Covid19; ARDS; Right Ventricular Dysfunction
• Intervention / Treatment: Diagnostic test: Echocardiography

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 Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

• Study Contact: Name: Ben Shelley, MD; Phone Number: 4293 01419515000; Email: benjamin.shelley@glasgow.ac.uk
• Study Contact Backup: Name: Philip McCall, MD; Phone Number: 4293 01419515000; Email: philipmccall@nhs.net

Study Locations

• United Kingdom
  • Aberdeen, United Kingdom, AB25 2ZN
    • Recruiting
    • Aberdeen Royal Infirmary
    • Contact: James MacBrayne
    • Principal Investigator: James MacBrayne
  • Ayr, United Kingdom, KA6 6DX
    • Recruiting
    • Univeristy Hospital, Ayr
    • Contact: Derek McLaughlan
    • Principal Investigator: Derek McLaughlan
  • Clydebank, United Kingdom
    • Recruiting
    • Golden Jubilee National Hospital
    • Contact: Ben Shelley, MD; Phone Number: 4293 0141 9515000; Email: b.shelley@clinmed.gla.ac.uk
    • Principal Investigator: Ben Shelley, MD
    • Principal Investigator: Philip McCall, MD
  • Dumfries, United Kingdom, DG2 8RX
    • Recruiting
    • Dumfries and Galloway Royal Infirmary
    • Contact: Alexander McDonald
    • Principal Investigator: Alexander McDonald
  • East Kilbride, United Kingdom, G75 8RG
    • Recruiting
    • University Hospital Hairmyres
    • Contact: Nina Tatarkowska, MBChB
    • Principal Investigator: Nina Tatarkowska, MBChB
  • Glasgow, United Kingdom, G51 4TF
    • Recruiting
    • Queen Elizabeth University Hospital
    • Contact: Malcolm Sim, MD
    • Principal Investigator: Malcolm Sim, MD
  • Glasgow, United Kingdom
    • Recruiting
    • Glasgow Royal Infirmary
    • Contact: Alex Puxty, MBChB
    • Principal Investigator: Alex Puxty, MBChB
  • Inverness, United Kingdom, IV2 3JH
    • Recruiting
    • Raigmore Hospital
    • Contact: Benjamin Greatorex
    • Principal Investigator: Benjamin Greatorex
  • Kilmarnock, United Kingdom, KA2 0BE
    • Recruiting
    • University Hospital, Crosshouse
    • Contact: John Allan
    • Principal Investigator: John Allan
  • Paisley, United Kingdom, PA2 9PJ
    • Recruiting
    • Royal Alexandra Hospital
    • Contact: Lisa Gemmell, MBChB
    • Principal Investigator: Lisa Gemmell, MBChB
  • Wishaw, United Kingdom, ML2 0DP
    • Recruiting
    • University Hospital, Wishaw
    • Contact: Dominic Strachan, MBChB
    • Principal Investigator: Dominic Strachan, MBChB

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients requiring tracheal intubation and intermittent positive pressure ventilation for COVID-19 in Scottish intensive care units

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University of Glasgow
• Collaborators: Golden Jubilee National Hospital; Robertson Centre for Biostatistics
• Investigators: Study Director: Ben Shelley, MD, University of Glasgow

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 2, 2020
• Primary Completion (Anticipated): March 31, 2021
• Study Completion (Anticipated): April 30, 2021

Study Registration Dates

• First Submitted: February 12, 2021
• First Submitted That Met QC Criteria: February 17, 2021
• First Posted (Actual): February 21, 2021

Study Record Updates

• Last Update Posted (Actual): February 21, 2021
• Last Update Submitted That Met QC Criteria: February 17, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: COVID-19; ARDS; Echocardiography; Right Ventricle
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Ventricular Dysfunction; Ventricular Dysfunction, Right
• Other Study ID Numbers: 20/COVID/17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No