Right Ventricle Function After Major Right Lung Resection

NCT04167241 | Unknown

• 1 other identifier: RIVER Trial
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Right Ventricular Dysfunction; Pneumonectomy; Status

Keywords

Right Ventricle Disfunction; Pneumonectomy; Echocardiography

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Post-operative outcome

  Within 3rd post-operative day

• Right ventricle failure

  Within 3rd post-operative day

• Post-operative quality of life

  3 months, post-operatively

Study Arms (1)

Patients submitted to right pneumonectomy or bi-lobectomy

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

Diagnostic Test: Echocardiography

Interventions

Echocardiography DIAGNOSTIC_TEST

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

Patients submitted to right pneumonectomy or bi-lobectomy

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients submitted to right pneumonectomy or bi-lobectomy

You may qualify if:

• Adults patients undergoing right pneumonectomy
• Adults patients undergoing pulmonary bilobectomy

You may not qualify if:

• 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

Sponsors & Collaborators

• Humanitas Clinical and Research Center: lead

MeSH Terms

Conditions

Ventricular Dysfunction, Right

Interventions

Echocardiography

Condition Hierarchy (Ancestors)

Ventricular Dysfunction; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Central Study Contacts

Enrico Giustiniano, MD

CONTACT

+390282247459; enrico.giustiniano@humanitas.it

Antonio Messina

CONTACT

antonio.messina@humanitas.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 8, 2019
• First Posted: November 18, 2019
• Study Start: November 8, 2019
• Primary Completion: November 7, 2020
• Study Completion: November 30, 2020
• Last Updated: November 18, 2019

Record last verified: 2019-11