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

NCT07362342 | Not Yet Recruiting

• 1 other identifier: 4590
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Lung Surgery; Right Ventricular Function

Outcome Measures

Primary Outcomes (1)

• Echocardiographic Measurement of RV dysfunction

  Measurement of TAPSE and/or S' wave using Tissue Doppler Imaging (TDI); TAPSE/PAPs ratio

  1 year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Prospective observational study in patients undergoing elective major thoracic surgery.

You may qualify if:

• 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%)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Istituto Clinico Humanitas: lead

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Fulvio Nisi

Study Record Dates

• First Submitted: January 15, 2026
• First Posted: January 23, 2026
• Study Start: January 20, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 23, 2026

Record last verified: 2026-01