Right Ventricle Function After Major Right Lung Resection

Right Ventricular Dysfunction Clinical Trial

— RIVER  

Official title:

Early Peri-operative Right Ventricle Dysfunction Following Major Lung Resection

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04167241
• Other study ID #: RIVER Trial
• Status: Not yet recruiting
• Start date: November 8, 2019
• Est. completion date: November 30, 2020

Study information

• Verified date: November 2019
• Source: Humanitas Clinical and Research Center
• Contact: Enrico Giustiniano, MD
• Phone: +390282247459
• Email: enrico.giustiniano[@]humanitas.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Pneumonectomy; Status
• Right Ventricular Dysfunction
• Ventricular Dysfunction
• Ventricular Dysfunction, Right

Intervention

Diagnostic Test:
• Echocardiography
Before and after right pneumonectomy or bi-lobectomy patients will receive echocardiography

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Humanitas Clinical and Research Center

Outcome

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