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
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | Echocardiography | Before 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.