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Right Ventricle Function After Major Right Lung Resection

Early Peri-operative Right Ventricle Dysfunction Following Major Lung Resection

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04167241
Acronym
RIVER
Enrollment
50
Registered
2019-11-18
Start date
2019-11-08
Completion date
2020-11-30
Last updated
2019-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pneumonectomy; Status, Right Ventricular Dysfunction

Keywords

Right Ventricle Disfunction, Pneumonectomy, Echocardiography

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.

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.

Interventions

DIAGNOSTIC_TESTEchocardiography

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

Sponsors

Humanitas Clinical and Research Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Prevalence of right ventricle disfunctionImmediately 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

MeasureTime frameDescription
Post-operative outcomeWithin 3rd post-operative dayPulmonary failure may be associated with post-operative pulmonary embolism
Right ventricle failureWithin 3rd post-operative dayRV dysfunction and RV-PA uncoupling may be associated with post-operative pulmonary hypertension occurring during the hospitalization period.
Post-operative quality of life3 months, post-operativelyDASI questionnaire

Contacts

Primary ContactEnrico Giustiniano, MD
enrico.giustiniano@humanitas.it+390282247459
Backup ContactAntonio Messina
antonio.messina@humanitas.it

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026