Right Ventricular Dysfunction in Ventilated Patients With COVID-19
COVID-RV
1 other identifier
observational
150
1 country
11
Brief Summary
Using echocardiography to investigate the incidence of RV dysfunction in ventilated patients with COVID-19.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2020
Shorter than P25 for all trials
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 2, 2020
CompletedFirst Submitted
Initial submission to the registry
February 12, 2021
CompletedFirst Posted
Study publicly available on registry
February 21, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2021
CompletedFebruary 21, 2021
February 1, 2021
7 months
February 12, 2021
February 17, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (12)
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
- +7 more secondary outcomes
Interventions
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
Patients requiring tracheal intubation and intermittent positive pressure ventilation for COVID-19 in Scottish intensive care units
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Glasgowlead
- Golden Jubilee National Hospitalcollaborator
- Robertson Centre for Biostatisticscollaborator
Study Sites (11)
Aberdeen Royal Infirmary
Aberdeen, AB25 2ZN, United Kingdom
Univeristy Hospital, Ayr
Ayr, KA6 6DX, United Kingdom
Golden Jubilee National Hospital
Clydebank, United Kingdom
Dumfries and Galloway Royal Infirmary
Dumfries, DG2 8RX, United Kingdom
University Hospital Hairmyres
East Kilbride, G75 8RG, United Kingdom
Queen Elizabeth University Hospital
Glasgow, G51 4TF, United Kingdom
Glasgow Royal Infirmary
Glasgow, United Kingdom
Raigmore Hospital
Inverness, IV2 3JH, United Kingdom
University Hospital, Crosshouse
Kilmarnock, KA2 0BE, United Kingdom
Royal Alexandra hospital
Paisley, PA2 9PJ, United Kingdom
University Hospital, Wishaw
Wishaw, ML2 0DP, United Kingdom
Related Publications (2)
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.
PMID: 33441361BACKGROUNDMcErlane 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.
PMID: 36370220DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ben Shelley, MD
University of Glasgow
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Honorary Clinical Associate Professor
Study Record Dates
First Submitted
February 12, 2021
First Posted
February 21, 2021
Study Start
September 2, 2020
Primary Completion
March 31, 2021
Study Completion
April 30, 2021
Last Updated
February 21, 2021
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will not share