Right Ventricle Function After Major Right Lung Resection (RIVER)

Humanitas Clinical and Research Center

Status: Unknown

Conditions: Pneumonectomy; Status; Right Ventricular Dysfunction

Treatments: Diagnostic Test: Echocardiography

Study type: Observational

Funder types: Other

Identifiers

NCT04167241

RIVER Trial

Details and patient eligibility

About

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.

Full description

The aim of this study is to identify the incidence of early RV systolic dysfunction (defined as Tricuspid Annular Plane Systolic Excursion (TAPSE) < 17 cm, S' (TDI) < 10 cm/s) and estimate the RV-PA (Right Ventricle-Pulmonary Artery) coupling as indicated by Guazzi et all. (TAPSE/PAPs ratio, where PAPs is the Systolic Pulmonary Artery Pressure) after major lung resection (bilobectomy and pneumonectomy) using echocardiography, and to assess if these modifications (RV dysfunction and RV-PA coupling) may be associated with post-operative cardiopulmonary complications occurring during the hospitalization period. Investigators also intend to evaluate if these changes are associated with impaired functional capacity at 3 months after surgery.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

50 participants in 1 patient group

Patients submitted to right pneumonectomy or bi-lobectomy

Description:

Consecutive, elective surgical patients submitted to right pneumonectomy or bi-lobectomy

Treatment:

Diagnostic Test: Echocardiography