Flow-Controlled Ventilation (FCV®): Advancing the Control of Respiratory Mechanics

Ventinova Medical and IES Medical develop the technology enabling Flow-Controlled Ventilation, an innovative approach to mechanical ventilation that enables active control of both inspiration and expiration.

Beyond conventional mechanical ventilation

Mechanical ventilation is an essential intervention in anaesthesia, intensive care and complex surgical procedures. However, the interaction between gas flow, airway pressure, lung volume and the mechanical properties of the respiratory system remains central to the development of more individualised ventilation strategies.

In this context, Flow-Controlled Ventilation (FCV®) introduces a different approach to respiratory support by actively controlling gas flow during both phases of the respiratory cycle.

Unlike conventional ventilation modes, in which expiration is generally passive, FCV® actively regulates expiratory flow. This allows the ventilator to control the evolution of intratracheal pressure throughout the entire respiratory cycle, rather than relying exclusively on the elastic recoil of the respiratory system during expiration.

This distinction is physiologically relevant because the temporal profiles of flow and pressure influence lung volume changes, gas distribution and the mechanical conditions under which ventilation takes place.

The physiological principles behind FCV®

FCV® is implemented in Evone®, a mechanical ventilator developed by Ventinova Medical. The system regulates inspiratory and expiratory flow using intratracheal pressure measurements and a pressure-compensated flow controller.

During inspiration, gas is delivered at a set flow until the configured peak pressure is reached. During expiration, gas is actively withdrawn under controlled flow conditions until the set end-expiratory pressure (EEP) is reached.

The resulting dynamic ventilation profile aims to produce gradual changes in pressure and volume, without the abrupt pressure drops associated with uncontrolled passive expiration.

From a respiratory physiology perspective, this approach provides opportunities to investigate several important mechanisms:

1. Intratracheal pressure dynamics

Active expiratory flow control enables clinicians to regulate the decline in intratracheal pressure during expiration. This provides a different pressure-time profile from conventional ventilation modes.

2. Lung mechanics and individualised ventilation

The relationship between pressure, flow and volume can inform the assessment of respiratory system mechanics and support the individualisation of ventilator settings.

3. Gas exchange efficiency

Oxygenation and carbon dioxide elimination are important physiological endpoints when comparing FCV® with conventional ventilation modes across different clinical settings.

4. Lung aeration and mechanical stress

Changes in flow and pressure profiles may influence lung volume distribution, regional aeration and the mechanical energy transferred to the respiratory system. The extent to which these physiological effects translate into improved clinical outcomes requires evaluation in appropriately designed clinical trials.

FCV® therefore represents more than a different ventilator setting: it is a distinct approach to controlling the mechanics of the respiratory cycle.

International clinical research is advancing

The growing scientific interest in FCV® is reflected in the research programme presented by PROVE Network, an international network investigating perioperative ventilation strategies and postoperative outcomes.

Several research initiatives are examining the feasibility, safety and potential clinical implications of flow-controlled ventilation in challenging surgical scenarios.

FLOW vs VOLUME

The randomised, single-centre FLOW vs VOLUME clinical trial compared flow-controlled ventilation with volume-controlled ventilation during one-lung ventilation in thoracic surgery.

The study included 78 patients and investigated intraoperative gas exchange, respiratory physiology and postoperative pulmonary complications.

The trial is registered in the German Clinical Trials Register under DRKS00022198. Its findings contribute to the clinical evaluation of FCV® in a setting where ventilation strategies must accommodate the physiological challenges of one-lung ventilation.

Compliance-guided flow-controlled ventilation

Another research area focuses on individualising FCV® settings according to respiratory system mechanics.

This includes the assessment of individualised positive end-expiratory pressure (PEEP) and driving pressure in challenging settings such as bariatric surgery, minimally invasive abdominal surgery and thoracic procedures involving one-lung ventilation.

Individualisation is an important aspect of protective ventilation because optimal settings may differ according to patient characteristics, respiratory mechanics and surgical conditions.

PROFLOW-ROBOTic and PROFLOW-THORACic

The PROFLOW research programme is extending the investigation of FCV® to multicentre clinical studies.

PROFLOW-ROBOTic is designed to investigate individualised FCV® compared with pressure-controlled ventilation in patients undergoing robot-assisted abdominal, urological or gynaecological surgery. Its pilot phase focuses on safety and feasibility and will help inform the design of a larger clinical trial.

PROFLOW-THORACic is intended to evaluate the effect of individualised FCV® compared with conventional ventilation on postoperative pulmonary complications in patients undergoing open or video-assisted thoracic surgery with one-lung ventilation.

Together, these research initiatives reflect an important transition from the investigation of physiological mechanisms towards the systematic evaluation of clinically relevant outcomes.

While early studies provide a basis for understanding the physiological effects of FCV®, its impact on postoperative pulmonary complications and other patient-centred outcomes must be established through robust clinical evidence.

Ventinova Medical and IES Medical: developing the technology behind FCV®

Ventinova Medical and IES Medical are at the forefront of the development and commercialisation of devices based on Flow-Controlled Ventilation technology.

Evone® is the mechanical ventilator designed to deliver FCV®, providing active control of inspiratory and expiratory flow throughout the respiratory cycle.

The platform also includes Tritube®, an ultrathin endotracheal tube designed for applications requiring a small airway access profile, and other devices developed for advanced airway management.

This combination of ventilation technology and specialised airway devices supports applications in which airway dimensions, surgical access and ventilation requirements present particular challenges.

Evone® is distinguished by its implementation of active inspiratory and expiratory flow control in a dedicated mechanical ventilator. This technology enables clinicians to explore a different approach to respiratory management while contributing to the growing body of research on individualised ventilation.

As the developers of this specialised FCV® technology platform, Ventinova Medical and IES Medical are committed to advancing its clinical application through technological development, education and collaboration with the scientific community.

From technological innovation to clinical evidence

The development of new ventilation strategies requires close collaboration between biomedical engineering, respiratory physiology and clinical practice.

Technological innovation must be accompanied by appropriate clinical evaluation, well-defined ventilation protocols and systematic assessment of safety and efficacy across relevant patient populations.

International research into FCV® is helping to clarify how its settings can be individualised, how its physiological effects compare with conventional ventilation and whether these differences can translate into meaningful improvements in patient outcomes.

Ventinova Medical and IES Medical remain committed to advancing Flow-Controlled Ventilation through continued innovation, professional education and collaboration with clinicians and researchers worldwide.

By controlling gas flow throughout the entire respiratory cycle, FCV® opens new opportunities to investigate and optimise the mechanics of mechanical ventilation. The next step is to translate this technological potential into robust clinical evidence and improved patient care.

Scientific references and further information

• PROVE Network — Flow-Controlled Ventilation: https://www.provenetwork.org/flow-controlled-ventilation
• Ventinova Medical — FCV® Technology: https://www.ventinovamedical.com/en/fcv-technology/full-control-ventilation
• Ventinova Medical — Evone® Mechanical Ventilator: https://www.ventinovamedical.com/en/products/evone
• FLOW vs VOLUME clinical trial — German Clinical Trials Register: DRKS00022198
• Ventinova Medical / IES Medical: https://www.iesmedical.es