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

February 17, 2021 updated by: Dr Ben Shelley, University of Glasgow
Using echocardiography to investigate the incidence of RV dysfunction in ventilated patients with COVID-19.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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:
        • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The prevalence of RV dysfunction in ventilated patients with COVID-19
Time Frame: 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).
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.
Time Frame: Up to 30-days following intubation and intermittent positive pressure ventilation
Up to 30-days following intubation and intermittent positive pressure ventilation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Association of ARDS and RV dysfunction
Time Frame: At time of echocardiography
At time of echocardiography
Association of micro/macro thrombi and RV dysfunction
Time Frame: At time of echocardiography
At time of echocardiography
The association of direct myocardial injury and RV dysfunction
Time Frame: At time of echocardiography
At time of echocardiography
The association of ventilation and RV dysfunction
Time Frame: At time of echocardiography
At time of echocardiography
Association of ARDS and 30-day mortality
Time Frame: Up to 30-days following intubation and intermittent positive pressure ventilation
Up to 30-days following intubation and intermittent positive pressure ventilation
Association of micro/macro thrombi and 30-day mortality
Time Frame: Up to 30-days following intubation and intermittent positive pressure ventilation
Up to 30-days following intubation and intermittent positive pressure ventilation
Association of direct myocardial injury and 30-day mortality
Time Frame: Up to 30-days following intubation and intermittent positive pressure ventilation
Up to 30-days following intubation and intermittent positive pressure ventilation
Association of ventilation and 30-day mortality
Time Frame: Up to 30-days following intubation and intermittent positive pressure ventilation
Up to 30-days following intubation and intermittent positive pressure ventilation
The difference in NP levels between patients with, and patients without, RV dysfunction.
Time Frame: At time of echocardiography
At time of echocardiography
The difference in hsTn between patients with, and patients without, RV dysfunction.
Time Frame: At time of echocardiography
At time of echocardiography
Association between hsTn and 30-day mortality in patients with, and patients without, RV dysfunction
Time Frame: Up to 30-days following intubation and intermittent positive pressure ventilation
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
Time Frame: Up to 30-days following intubation and intermittent positive pressure ventilation
Up to 30-days following intubation and intermittent positive pressure ventilation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Glasgow

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Golden Jubilee National Hospital
Robertson Centre for Biostatistics

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Ben Shelley, MD, University of Glasgow

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 2, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 12, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 17, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 21, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 21, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 17, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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