Study protocol for COVID-RV: a multicentre prospective observational cohort study of right ventricular dysfunction in ventilated patients with COVID-19

Abstract

IntroductionCOVID-19 can cause severe acute respiratory failure requiring management in intensive care unit with invasive ventilation and a 40% mortality rate. Cardiovascular manifestations are common and studies have shown an increase in right ventricular (RV) dysfunction associated with mortality. These studies, however, comprise heterogeneous patient groups with few requiring invasive ventilation. This study will investigate the prevalence and prognostic significance of RV dysfunction in ventilated patients with COVID-19 which may lead to targeted interventions to improve patient outcomes.Methods and analysisThis prospective multicentre observational cohort study will perform transthoracic echocardiography (TTE) in 150 patients with COVID-19 requiring invasive ventilation for more than 48 hours. RV dysfunction will be defined as TTE evidence of RV dilatation along with the presence of septal flattening. Baseline demographics, disease severity data and clinical information relating to proposed aetiological mechanisms of RV dysfunction (acute respiratory distress syndrome (ARDS), disordered coagulation, direct myocardial injury and ventilation) will be collected and analysed.Primary outcome measures include the prevalence of RV dysfunction and its association with 30-day mortality. Exploratory outcome measures will investigate the association of the proposed aetiological mechanisms of RV dysfunction to the primary outcomes.Prevalence of RV dysfunction will be determined along with 95% Clopper-Pearson CIs and 30-day survival will be analysed using logistic regression adjusting for patient demographics, phase of disease and baseline severity of illness. The role of potential aetiological factors (ARDS, disordered coagulation, direct myocardial injury and ventilation) in relation to the primary outcomes will be analysed using logistic regression.Ethics and disseminationApproval was gained from Scotland A Research Ethics Committee (REC reference 20/SS/0059). Findings will be disseminated by various methods including webinars, international presentations and publication in peer-reviewed journals.

The Right Ventricle in COVID-19

“…It is, indeed, well known that the quality of transthoracic echocardiographic images can be impaired by mechanical ventilation and suboptimal patient positioning in the ICU, as well as pulmonary disease itself [41]. Technical issues may be of particular concern for strain imaging, where the quality of images is essential for accurate strain tracking [42], which underlies the need of skilled and experienced echocardiographers to properly assess RV function in these complicated patients [43]. To summarize, there is now substantial evidence that RV dysfunction is a hallmark pathophysiological alteration associated with COVID-19, as extensively reviewed by Dandel [51].…”

COVID-19 nach Herztransplantation: Erfahrungen eines deutschen Transplantationszentrums

“…Zudem wurde in unserer Kohorte keine invasive Beatmung oder ECMO-Therapie durchgeführt. Beide gelten als Faktoren, die ansonsten insbesondere bei COVID-19-Patienten ebenfalls mit einer rechtsventrikulären Dysfunktion einhergehen [ 26 ].…”

“…In unserer Kohorte zeigten sich die D‑Dimere nur gering erhöht (1,75 mg/l) und damit 4‑mal geringer als in schweren COVID-19 Fällen in HTx-Patienten (6,6 mg/dl) [ 16 ]. Zudem finden sich nach aktueller Datenlage thrombembolische Ereignisse in herztransplantierten Patienten vornehmlich in schweren COVID-19-Verläufen [ 26 ].…”

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

“…Study protocol and methods have previously been reported [14]. We conducted a prospective, observational cohort study involving 10 ICUs in NHS Scotland.…”