None listed
Conditions
Brief summary
This is a prospective, randomized observational study investigating two lung ventilation strategies during video-assisted thoracoscopic surgery (VATS) requiring one-lung ventilation (OLV): Volume Controlled Ventilation (VCV) and Flow Controlled Ventilation (FCV). OLV carries a risk of intraoperative hypoxemia and postoperative pulmonary complications (PPC). While VCV is the current standard technique, FCV is a newer ventilation mode that uses linear inspiratory and expiratory flow and may improve oxygenation and lung protection. The primary aim of this study is to compare intraoperative oxygenation between VCV and FCV by measuring arterial partial pressure of oxygen (PaO2) at 30 minutes after initiation of OLV (FiO2: 1.0). Secondary aims include comparing mechanical power and postoperative pulmonary complications. In addition, this study will collect detailed ventilatory data from each breath to develop an artificial intelligence (AI)-based model to estimate mechanical power during FCV. Mechanical power has been strongly associated with ventilator-induced lung injury, but no standardised method exists for FCV. The AI model will be trained using VCV-derived mechanical power and applied to FCV data for validation. A total of 120 patients will be randomized equally to either VCV or FCV. The study will contribute to improving lung-protective ventilation strategies and support the development of an AI-based mechanical power estimation model for thoracic anesthesia.
Interventions
This is a prospective, randomised controlled study comparing two intraoperative ventilation strategies during one-lung ventilation (OLV) in patients undergoing video-assisted thoracoscopic surgery (VATS). Eligible patients will be randomly allocated (1:1 ratio) into one of the following two groups using a computer-generated block randomisation schedule:
Flow-Controlled Ventilation (FCV) group – Intervention arm
Patients in this group will be ventilated using the Evone® FCV system, which provides
This is a prospective, randomised controlled study comparing two intraoperative ventilation strategies during one-lung ventilation (OLV) in patients undergoing video-assisted thoracoscopic surgery (VATS). Eligible patients will be randomly allocated (1:1 ratio) into one of the following two groups using a computer-generated block randomisation schedule: Flow-Controlled Ventilation (FCV) group – Intervention arm Patients in this group will be ventilated using the Evone® FCV system, which provides constant inspiratory and expiratory flow. Ventilation parameters will be adjusted to maintain a driving pressure (DP) of 12 cmH2O, with positive end-expiratory pressure (PEEP) set at 5 cmH2O, and ETCO2 maintained between 35–40 mmHg by flow titration. FiO2 will follow the same protocol as in the VCV group. - Procedure duration: 1 hour - The procedure will be performed by an experienced anesthesiologist - Compliance with the procedure will be monitored through ventilation parameters, blood gas, and hemodynamics. The inhaled oxygen fraction (FiO2) will start at 0.6 with the transition to OLV and will be increased to 1.0 at 15 minutes of OLV. An arterial blood gas sample will be taken at 30 minutes of OLV. After that, it will be reduced back to 0.6. Ventilation management will be performed according to institutional standard practices.
Sponsors
Onur KUCUK
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- Adults 18 years and older - Elective video-assisted thoracoscopic surgery (VATS) requiring one-lung ventilation (OLV) - Lung malignancy (primary or metastatic) - Airway management with a double-lumen tube or bronchial blocker - Preoperative written informed consent - Necessary ventilator modes/devices available to allow randomization to VCV or FCV per protocol
Exclusion criteria
- Age <18 years - Emergency thoracic surgery - Severe pulmonary disease impairing gas exchange: - Severe COPD (GOLD stage III–IV) or FEV1 55 mmHg) - Severe restrictive chest wall disease or prior pneumonectomy - Severe hypoxemia risk before induction (SpO2 < 90% on room air) - ASA physical status IV–V - Hemodynamic instability requiring high-dose vasopressors - Severe cardiac dysfunction (EF < 35%) or uncontrolled arrhythmia - Pulmonary hypertension (mean PAP > 35 mmHg) - Body mass index (BMI) > 35 kg/m² - Known or anticipated difficult airway that precludes safe lung isolation - History of tracheal or bronchial stenosis preventing placement of lung isolation devices - Pregnant or breastfeeding women - Participation in another interventional clinical study within 30 days - Refusal to provide informed consent
Outcome results
None listed