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

Recruitingn/aAges 18 Years - anyAllIstituto Clinico Humanitas
NCT07362342 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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)
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What it tests

  • Not listed
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Where

1 site
Humanitas Research Hospital
Rozzano, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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