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Clinical Trials/NCT04167241
NCT04167241
Unknown
Not Applicable

Early Peri-operative Right Ventricle Dysfunction Following Major Lung Resection

Humanitas Clinical and Research Center0 sites50 target enrollmentNovember 8, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Right Ventricular Dysfunction
Sponsor
Humanitas Clinical and Research Center
Enrollment
50
Primary Endpoint
Prevalence of right ventricle disfunction
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 8, 2019
End Date
November 30, 2020
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Humanitas Clinical and Research Center
Responsible Party
Principal Investigator
Principal Investigator

Enrico Giustiniano

Principal Investigator

Humanitas Clinical and Research Center

Eligibility Criteria

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

Outcomes

Primary Outcomes

Prevalence of right ventricle disfunction

Time Frame: 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 Outcomes

  • Post-operative outcome(Within 3rd post-operative day)
  • Post-operative quality of life(3 months, post-operatively)
  • Right ventricle failure(Within 3rd post-operative day)

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