RIVER: Right Ventricle Function After Major Right Lung Resection

Sponsor

Humanitas Clinical and Research Center (Other)

Overall Status

Unknown status

CT.gov ID

NCT04167241

Collaborator

(none)

Enrollment

12.7

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Right Ventricular Dysfunction Pneumonectomy; Status	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 Design

Study Type:

Observational

Anticipated Enrollment :

50 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Early Peri-operative Right Ventricle Dysfunction Following Major Lung Resection

Anticipated Study Start Date :

Nov 8, 2019

Anticipated Primary Completion Date :

Nov 7, 2020

Anticipated Study Completion Date :

Nov 30, 2020

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Prevalence of right ventricle disfunction [Immediately after the awakening from general anesthesia (Day 0)]
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.

Secondary Outcome Measures

Post-operative outcome [Within 3rd post-operative day]
Pulmonary failure may be associated with post-operative pulmonary embolism
Right ventricle failure [Within 3rd post-operative day]
RV dysfunction and RV-PA uncoupling may be associated with post-operative pulmonary hypertension occurring during the hospitalization period.
Post-operative quality of life [3 months, post-operatively]
DASI questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Humanitas Clinical and Research Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Enrico Giustiniano, Principal Investigator, Humanitas Clinical and Research Center

ClinicalTrials.gov Identifier:

NCT04167241

Other Study ID Numbers:

RIVER Trial

First Posted:

Nov 18, 2019

Last Update Posted:

Nov 18, 2019

Last Verified:

Nov 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Enrico Giustiniano, Principal Investigator, Humanitas Clinical and Research Center

Right Ventricle Disfunction

Pneumonectomy

Echocardiography

Additional relevant MeSH terms:

Ventricular Dysfunction

Ventricular Dysfunction, Right

Study Results

No Results Posted as of Nov 18, 2019