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NCT Number: NCT07392086

Comparison of FCV and VCV in One-Lung Ventilation

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Health Sciences University Dr. Abdurrahman Yurtarslan Ankara Oncology Training and Research Hospital

Ankara, Yenimahalle, 06200, Turkey (Türkiye)

Location status: Recruiting

Location contact

Güldeniz Argun, Proffesör

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Oxygenation Capacity

    Time frame: Intraoperative period (during one-lung ventilation)

    PaO₂/FiO₂ Ratio

Secondary outcomes

  1. Respiratory parameters

    Time frame: Intraoperative period (during one-lung ventilation)

    mechanical power (MP)

Study contacts

Contact information is provided by the study sponsor or research team.

Seher Altınel, Assoc.Prof

CONTACT

[email protected]

Ökkeş Hakan Miniksar, Assoc.Prof

CONTACT

[email protected]

+905304686718

Sponsors and collaborators

Lead sponsor

Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

Other

Collaborators

  • Ataturk University
  • Kocaeli City Hospital
  • Sakarya University
  • Yedikule Training and Research Hospital

Registry information

Official study title

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)

Acronym: FCVOLVent

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 6, 2026
Registry last updated
Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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