Tokyo, Sept. 10 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062860) titled 'Study on the Relationship Between Ventilator Settings During One-Lung Ventilation and Postoperative Pulmonary Complications' on Sept. 9.

Study Type: Observational

Primary Sponsor: Institute - The University of Osaka

Condition: Condition - Adult patients undergoing thoracic surgery requiring one-lung ventilation (OLV) Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The objective of this study is to prospectively evaluate the impact of intraoperative ventilator parameters, particularly driving pressure, during one-lung ventilation (OLV) in thoracic surgery on postoperative pulmonary complications (PPCs), and to determine the incidence and associated risk factors of PPCs.

Postoperative pulmonary complications frequently occur after surgery, with an incidence reported to be as high as 31.4% in patients undergoing thoracic surgery requiring OLV. PPCs have a substantial impact on patient outcomes and are associated with increased postoperative morbidity, prolonged hospital stay, and higher mortality. However, optimal ventilatory management during OLV, particularly with respect to driving pressure, has not been established. Previous studies have demonstrated an association between driving pressure and PPCs in general surgical populations and in patients with acute respiratory distress syndrome (ARDS); however, evidence specific to OLV remains limited, and retrospective studies have not demonstrated a significant association between driving pressure and PPCs.

Through this study, we aim to clarify the relationship between ventilator parameters during OLV and postoperative pulmonary complications, thereby providing insights that may inform optimal ventilatory strategies in clinical practice. Basic objectives2 - Others

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Adult patients aged 18 years or older Patients scheduled to undergo lung resection surgery under one-lung ventilation (OLV) Patients with an expected surgical duration of 3 hours or longer, including emergency surgeries Patients at high risk for postoperative pulmonary complications (PPCs) Key exclusion criteria - Pregnant or breastfeeding patients Patients diagnosed with acute respiratory distress syndrome (ARDS) prior to surgery Patients with heart failure classified as New York Heart Association (NYHA) class III or IV Patients with increased intracranial pressure Patients who received mechanical ventilation within 15 days prior to surgery Patients with pneumothorax or giant bullae Patients requiring oxygen therapy or continuous positive airway pressure Patients with a history of lung resection Patients in whom a bronchial blocker is used Patients with a history of neuromuscular disease Patients requiring extracorporeal circulation during surgery Patients deemed inappropriate for inclusion by the investigators Target Size - 350

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2025 Year 12 Month 16 Day Date of IRB - 2025 Year 12 Month 23 Day Anticipated trial start date - 2026 Year 05 Month 11 Day Last follow-up date - 2028 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069994

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