Clinical trial NCT04167241: Right Ventricle Function After Major Right Lung Resection
Official title: Early Peri-operative Right Ventricle Dysfunction Following Major Lung Resection
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Right Ventricular Dysfunction
Pneumonectomy; Status
Keywords: Right Ventricle Disfunction
Pneumonectomy
Echocardiography
Lead sponsor: Humanitas Clinical and Research Center
Sponsor class: OTHER
First posted: 2019-11-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients submitted to right pneumonectomy or bi-lobectomy

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.

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

Primary outcomes:
measure: Prevalence of right ventricle disfunction
timeFrame: Immediately after the awakening from general anesthesia (Day 0)
Secondary outcomes:
measure: Post-operative outcome
timeFrame: Within 3rd post-operative day
measure: Right ventricle failure
timeFrame: Within 3rd post-operative day
measure: Post-operative quality of life
timeFrame: 3 months, post-operatively
Other outcomes:
Locations:
Study officials:
References: