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RecruitingNCT07392086

Comparison of FCV and VCV in One-Lung Ventilation

Comparison of the Effects of Flow-Controlled Ventilation (FCV) and Volume-Controlled Ventilation (VCV) on Respiratory Mechanics and Gas Exchange During One-Lung Ventilation: A Multicenter Prospective Observational Study (FCVOLVent)

Status
Recruiting
Phase
Study type
Observational
Enrollment
60 (estimated)
Sponsor
Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital · Academic / Other
Sex
All
Age
18 Years – 80 Years
Healthy volunteers
Not accepted

Summary

One-lung ventilation (OLV) is commonly used during thoracic surgery but may negatively affect lung mechanics and gas exchange. Different ventilation strategies are used during OLV, and their effects on respiratory parameters remain an important clinical concern. Flow-controlled ventilation (FCV) is a newer ventilation mode that allows precise control of inspiratory and expiratory flow, potentially improving lung mechanics and gas exchange. Volume-controlled ventilation (VCV) is a widely used conventional ventilation strategy during thoracic anesthesia. The FCVOLVent study is a multicenter, prospective observational study designed to compare the effects of FCV and VCV during one-lung ventilation in adult patients undergoing thoracic surgery. Patients will be ventilated with either FCV or VCV as part of routine clinical practice. The study aims to evaluate respiratory mechanics and oxygenation parameters, including the PaO₂/FiO₂ ratio, airway pressures, lung compliance, and mechanical power during surgery. Data will be collected at predefined time points during one-lung ventilation. The results of this study are expected to provide real-world clinical evidence on the potential advantages and limitations of flow-controlled ventilation compared with volume-controlled ventilation during one-lung ventilation.

Detailed description

Detailed Description One-lung ventilation (OLV) is a fundamental anesthetic technique in thoracic surgery; however, it is frequently associated with impaired respiratory mechanics, ventilation-perfusion mismatch, and compromised gas exchange. Volume-controlled ventilation (VCV) is the most commonly used ventilation mode during OLV, but it may result in uneven gas distribution, higher peak airway pressures, and potential lung injury. Flow-controlled ventilation (FCV) is a novel ventilation mode characterized by constant and controlled inspiratory and expiratory flow, allowing precise regulation of airway pressures and lung volumes. Previous experimental and limited clinical data suggest that FCV may improve lung recruitment, optimize respiratory mechanics, and enhance gas exchange compared with conventional ventilation strategies. The FCVOLVent study is a multicenter, prospective observational study designed to compare the effects of FCV and VCV on respiratory mechanics and gas exchange in adult patients undergoing thoracic surgery requiring one-lung ventilation. Patients will be ventilated according to the ventilation strategy routinely used at each participating center, either FCV or VCV, without randomization or intervention beyond standard clinical practice. Primary outcomes include intraoperative respiratory mechanics parameters such as dynamic compliance, airway pressures, and driving pressure during OLV. Secondary outcomes include arterial blood gas variables, oxygenation indices, carbon dioxide elimination, and selected perioperative clinical parameters. Data will be collected at predefined time points during two-lung ventilation and one-lung ventilation phases. The study aims to provide real-world clinical evidence regarding the potential advantages and limitations of FCV compared with VCV in thoracic anesthesia practice. By evaluating ventilation strategies across multiple centers, the FCVOLVent study seeks to contribute to a better understanding of lung-protective ventilation approaches during one-lung ventilation and to inform future interventional trials in this field.

Conditions

Timeline

Start date
2026-01-01
Primary completion
2026-07-30
Completion
2026-12-01
First posted
2026-02-06
Last updated
2026-02-06

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT07392086. Inclusion in this directory is not an endorsement.