Comparison of FCV and VCV in One-Lung Ventilation (FCVOLVent)

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)

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.

Study Overview

• Status: Recruiting
• Conditions: Thoracic Surgery; Respiratory Mechanics; One-lung Ventilation (OLV)

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.

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Ökkeş Hakan Miniksar, Assoc.Prof; Phone Number: +905304686718; Email: hminiksar@yahoo.com
• Study Contact Backup: Name: Seher Altınel, Assoc.Prof; Email: altinelseher@yahoo.com

Study Locations

• Turkey (Türkiye)
  • Yenimahalle
    • Ankara, Yenimahalle, Turkey (Türkiye), 06200
      • Recruiting
      • Health Sciences University Dr. Abdurrahman Yurtarslan Ankara Oncology Training and Research Hospital
      • Contact: Güldeniz Argun, Proffesör; Email: guldargun@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Adult patients aged 18 years and older undergoing thoracic surgery requiring one-lung ventilation with flow-controlled ventilation (FCV) or volume-controlled ventilation (VCV).

Description

Inclusion Criteria Adult patients aged 18 years and older Patients undergoing thoracic surgery requiring one-lung ventilation (OLV) Requirement for one-lung ventilation for at least 30 minutes American Society of Anesthesiologists (ASA) physical status I-III Provision of written informed consent Patients ventilated with flow-controlled ventilation (FCV) or volume-controlled ventilation (VCV) as part of routine clinical practice

Exclusion Criteria Requirement for emergency surgery History of untreated asthma High pulmonary risk, defined as predicted postoperative FEV₁ < 20 mL/kg in males and < 18 mL/kg in females High cardiac risk, including advanced cardiomyopathy with left ventricular ejection fraction < 30% Body mass index (BMI) > 35 kg/m² Contraindication to total intravenous anesthesia (TIVA) Evidence of pulmonary infection prior to surgery Presence of other significant pulmonary pathologies (e.g., tuberculosis, bullous lung disease, bronchiectasis) Severe COPD (GOLD stage III-IV) or significant restrictive lung disease Age < 18 years or > 80 years, or pregnancy ASA physical status IV or higher Uncontrolled arrhythmia or history of myocardial infarction within the past 3 months Inability to provide informed consent

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
All participants; One-Lung Ventilation with Volume-Controlled Ventilation (VCV)
Prospective observational cohort study; Flow-Controlled Ventilation during One-Lung Ventilation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxygenation Capacity	PaO₂/FiO₂ Ratio	Intraoperative period (during one-lung ventilation)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Respiratory parameters	mechanical power (MP)	Intraoperative period (during one-lung ventilation)

Collaborators and Investigators

• Sponsor: Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
• Collaborators: Ataturk University; Sakarya University; Yedikule Training and Research Hospital; Kocaeli City Hospital
• Investigators: Study Chair: Hakan Miniksar, Health Sciences University Dr. Abdurrahman Yurtarslan Ankara Oncology Training and Research Hospital

Publications and helpful links

General Publications

• Bialka S, Palaczynski P, Szuldrzynski K, Wichary P, Kowalski D, van der Hoorn JWA, Bottinger L, Misiolek H. Flow-controlled ventilation - a new and promising method of ventilation presented with a review of the literature. Anaesthesiol Intensive Ther. 2022;54(1):62-70. doi: 10.5114/ait.2022.112889.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2026
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: January 22, 2026
• First Submitted That Met QC Criteria: January 29, 2026
• First Posted (Actual): February 6, 2026

Study Record Updates

• Last Update Posted (Actual): February 6, 2026
• Last Update Submitted That Met QC Criteria: January 29, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: One-Lung Ventilation; Thoracic Anesthesia; Volume-Controlled Ventilation; Flow-Controlled Ventilation
• Other Study ID Numbers: 2025-11/1250

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No