Right Ventricular Dysfunction Clinical Trial
— RIVEROfficial title:
Early Peri-operative Right Ventricle Dysfunction Following Major Lung Resection
Major lung resection is associated with high post-operative morbidity and mortality and
significant long-term decreased functional capacity, especially due to cardiorespiratory
complications.
RV (Right Ventricle) ejection, pulmonary artery pressure and tone are tightly coupled. The RV
is exquisitely sensitive to changes in afterload. When pulmonary vascular reserve is
compromised RV ejection may be also compromised, increasing right atrial pressure and
limiting maximal cardiac output. Acute increase in RV outflow resistance, as may occur with
acute pulmonary embolism will cause acute RV dilatation and, by ventricular interdependence,
markedly decreased LV (Left Ventricle) compliance, rapidly spiraling to acute cardiogenic
shock and death.
Most of the studies on RV function after lung resection are small and have found different
results, and sometimes conflicting findings. As far as the investigators know, there are no
data on the incidence of the RV dysfunction after major lung resection
(pneumonectomy/bilobectomy) and it's not clear if there is some direct association between
the RV dysfunction and post-operative complications. If so, early detection of RV dysfunction
after major lung resection could provide the opportunity for interventional therapy with
consequent possible improvement of these patients' prognosis.
Status | Not yet recruiting |
Enrollment | 50 |
Est. completion date | November 30, 2020 |
Est. primary completion date | November 7, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility |
Inclusion Criteria: - Adults patients undergoing right pneumonectomy - Adults patients undergoing pulmonary bilobectomy Exclusion Criteria: - Left pneumonectomy (it will not permit TTE postoperatively) - Completion pneumonectomy - Patients suffering from any myocardial disease - Preceding Pulmonary Embolism - Pregnancy - Potential pregnancy - Patients enrolled into another trial |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Humanitas Clinical and Research Center |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Prevalence of right ventricle disfunction | Incidence of early RV systolic dysfunction (defined as TAPSE < 17 mm, S' (TDI) < 10 cm/s) and estimate the RV-PA coupling as indicated by Guazzi et al. (TAPSE/PAPs ratio mm/mmHg) after major lung resection (bilobectomy and pneumonectomy) using echocardiography. | Immediately after the awakening from general anesthesia (Day 0) | |
Secondary | Post-operative outcome | Pulmonary failure may be associated with post-operative pulmonary embolism | Within 3rd post-operative day | |
Secondary | Right ventricle failure | RV dysfunction and RV-PA uncoupling may be associated with post-operative pulmonary hypertension occurring during the hospitalization period. | Within 3rd post-operative day | |
Secondary | Post-operative quality of life | DASI questionnaire | 3 months, post-operatively |
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