Clinical Trials Directory

Trials / Unknown

UnknownNCT04167241

Right Ventricle Function After Major Right Lung Resection

Early Peri-operative Right Ventricle Dysfunction Following Major Lung Resection

Status
Unknown
Phase
Study type
Observational
Enrollment
50 (estimated)
Sponsor
Humanitas Clinical and Research Center · Academic / Other
Sex
All
Age
18 Years – 85 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed 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.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTEchocardiographyBefore and after right pneumonectomy or bi-lobectomy patients will receive echocardiography

Timeline

Start date
2019-11-08
Primary completion
2020-11-07
Completion
2020-11-30
First posted
2019-11-18
Last updated
2019-11-18

Source: ClinicalTrials.gov record NCT04167241. Inclusion in this directory is not an endorsement.