Right Ventricle Function After Major Right Lung Resection (RIVER)

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.

Study Overview

• Status: Unknown
• Conditions: Right Ventricular Dysfunction; Pneumonectomy; Status
• Intervention / Treatment: Diagnostic test: Echocardiography

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.

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: Enrico Giustiniano, MD; Phone Number: +390282247459; Email: enrico.giustiniano@humanitas.it
• Study Contact Backup: Name: Antonio Messina; Email: antonio.messina@humanitas.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients submitted to right pneumonectomy or bi-lobectomy

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients submitted to right pneumonectomy or bi-lobectomy; Consecutive, elective surgical patients submitted to right pneumonectomy or bi-lobectomy	Diagnostic test: Echocardiography; Before and after right pneumonectomy or bi-lobectomy patients will receive echocardiography

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative outcome	Pulmonary failure may be associated with post-operative pulmonary embolism	Within 3rd post-operative day
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
Post-operative quality of life	DASI questionnaire	3 months, post-operatively

Collaborators and Investigators

• Sponsor: Humanitas Clinical and Research Center

Study record dates

Study Major Dates

• Study Start (Anticipated): November 8, 2019
• Primary Completion (Anticipated): November 7, 2020
• Study Completion (Anticipated): November 30, 2020

Study Registration Dates

• First Submitted: November 8, 2019
• First Submitted That Met QC Criteria: November 15, 2019
• First Posted (Actual): November 18, 2019

Study Record Updates

• Last Update Posted (Actual): November 18, 2019
• Last Update Submitted That Met QC Criteria: November 15, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: Echocardiography; Pneumonectomy; Right Ventricle Disfunction
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Ventricular Dysfunction; Ventricular Dysfunction, Right
• Other Study ID Numbers: RIVER Trial

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No