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Recruiting Observational

RIght VEntricle Response to Major Lung Resection in VATS and Robotic Surgery

NCT07362342 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2026-01-20
Last updated
2026-06-25

Condition(s) studied

Lung SurgeryRight Ventricular Function

Study summary

Major pulmonary resection is associated with high postoperative morbidity and mortality, mainly due to cardiorespiratory complications. Right ventricular (RV) function is closely related to pulmonary artery pressure and tone, and it is particularly sensitive to changes in afterload. An increase in RV flow resistance can lead to acute RV dilation and reduced left ventricular compliance, potentially progressing to cardiogenic shock. In a previous study (RIVER), it was observed that increased afterload following open thoracic surgery reduces RV function, although this impairment remains subclinical. The aim of this study is to investigate the same parameters in patients with severe cardiovascular comorbidities undergoing pulmonary resection via minimally invasive approaches (VATS and robotic surgery) compared to open thoracotomy.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Adult patients aged ≥18 years * Scheduled for elective lobectomy (or bilobectomy) via minimally invasive or open thoracic surgery * Ability to provide written informed consent at the time of hospital admission * Moderate to high cardiopulmonary risk, defined by at least one of the following criteria: * ASA physical status classification 3 * Predicted postoperative FEV1 \<60% and 6-minute walk test \<400 m or cardiopulmonary exercise test \<20 ml/kg/min * DASI index \<34 * RCRI \>2 * Coronary artery disease * Heart failure * Right ventricular systolic dysfunction (TAPSE \<17 mm and/or S' wave on TDI \<10 cm/s) * Left ventricular systolic dysfunction (EF \<55%) Exclusion Criteria * Urgent/emergency surgery * History of pulmonary embolism * Previous right or left pneumonectomy * Previous lobectomy * Completion pneumonectomy * Pregnancy (confirmed or suspected) * History of severe pulmonary hypertension (PAPs \>40 mmHg)

Primary outcome measure(s)

  • Echocardiographic Measurement of RV dysfunction — 1 year
    Measurement of TAPSE and/or S' wave using Tissue Doppler Imaging (TDI); TAPSE/PAPs ratio

Trial sites (1)

FacilityCityRegionStatus
Humanitas Research Hospital Rozzano MI Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07362342 on ClinicalTrials.gov ↗ ← All trials in Italy