One-lung Ventilation (OLV)FCVOLVentNCT07392086
Comparison of FCV and VCV in One-Lung Ventilation
An observational study of One-lung Ventilation (OLV) and Thoracic Surgery, run by Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- One-lung Ventilation (OLV), Thoracic Surgery, Respiratory Mechanics
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2026to 1 Dec 2026
- How long will I take part?
- 1 Year
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Seher Altınel, Assoc.Prof contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Health Sciences University Dr. Abdurrahman Yurtarslan Ankara Oncology Training and Research Hospital
Ankara, Yenimahalle, 06200
Güldeniz Argun, Proffesör, guldargun@yahoo.com
About this study
Official 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)
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.
Read more
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.
Read the 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.
- Keywords
- Flow-Controlled Ventilation, Thoracic Anesthesia, Volume-Controlled Ventilation, One-Lung Ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| All participants | One-Lung Ventilation with Volume-Controlled Ventilation (VCV) | |
| Prospective observational cohort study | Flow-Controlled Ventilation during One-Lung Ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygenation Capacity
PaO₂/FiO₂ Ratio
Measured: Intraoperative period (during one-lung ventilation)
Secondary outcomes (1)
Respiratory parameters
mechanical power (MP)
Measured: Intraoperative period (during one-lung ventilation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start1 Jan 2026
- Primary completion30 Jul 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for One-lung Ventilation (OLV)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Kocaeli City Hospital, Yedikule Training and Research Hospital, Sakarya University, Ataturk University
- Responsible party
- Principal investigator, Hakan Miniksar, Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
- Investigators
- Hakan Miniksar, Study chair, Health Sciences University Dr. Abdurrahman Yurtarslan Ankara Oncology Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07392086
- Sponsor's protocol ID
- 2025-11/1250
- Acronym
- FCVOLVent
- Status last verified
- Jan 2026
- First submitted
- 22 Jan 2026
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 35142160