NCT07392086

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
4mo left

Started Jan 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress64%
Jan 2026Dec 2026

Study Start

First participant enrolled

January 1, 2026

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

January 22, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 6, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2026

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

February 6, 2026

Status Verified

January 1, 2026

Enrollment Period

7 months

First QC Date

January 22, 2026

Last Update Submit

January 29, 2026

Conditions

Keywords

Flow-Controlled VentilationThoracic AnesthesiaVolume-Controlled VentilationOne-Lung Ventilation

Outcome Measures

Primary Outcomes (1)

  • Oxygenation Capacity

    PaO₂/FiO₂ Ratio

    Intraoperative period (during one-lung ventilation)

Secondary Outcomes (1)

  • Respiratory parameters

    Intraoperative period (during one-lung ventilation)

Study Arms (2)

All participants

One-Lung Ventilation with Volume-Controlled Ventilation (VCV)

Prospective observational cohort study

Flow-Controlled Ventilation during One-Lung Ventilation

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Ankara, Yenimahalle, 06200, Turkey (Türkiye)

RECRUITING

Related Publications (1)

  • 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 Officials

  • Hakan Miniksar

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

    STUDY CHAIR

Central Study Contacts

Ökkeş Hakan Miniksar, Assoc.Prof

CONTACT

Seher Altınel, Assoc.Prof

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Anesthesiology and Reanimation, Principal Investigator

Study Record Dates

First Submitted

January 22, 2026

First Posted

February 6, 2026

Study Start

January 1, 2026

Primary Completion

July 30, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

February 6, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations