NCT07362342 RIght VEntricle Response to Major Lung Resection in VATS and Robotic Surgery
| NCT ID | NCT07362342 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Istituto Clinico Humanitas |
| Condition | Lung Surgery |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2026-01-20 |
| Primary Completion | 2027-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2026-01-20 with a primary completion date of 2027-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07362342 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Lung Surgery. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07362342 currently recruiting?
Yes, NCT07362342 is actively recruiting participants. Contact the research team at enrico.giustiniano@humanitas.it for enrollment information.
Where is the NCT07362342 trial being conducted?
This trial is being conducted at Rozzano, Italy.
Who is sponsoring the NCT07362342 clinical trial?
NCT07362342 is sponsored by Istituto Clinico Humanitas. The trial plans to enroll 100 participants.