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Report

Teaser, summary, work performed and final results

Periodic Reporting for period 4 - EVA (EVA - patient ventilation beyond limits)

Teaser

Summary

Current standard patient ventilation techniques Volume Controlled Ventilation (VCV) and Pressure Controlled Ventilation (PCV) rely on passive and uncontrolled expiration, requiring an endotracheal tube with outer diameter (OD) of 8-11 mm. This thick tube hampers surgical view during oral/ throat surgery and increases patient discomfort after and while waking up. The uncontrolled expiration is described to induce alveolar collapse and lung damage.
FCV is a new ventilation technique, unique in controlling both the inspiration phase and expiration phase. The development of the first mechanical ventilator providing FCV is a key step in ventilation towards less-invasive, tailored and improved patient care as it enables:
1. Full ventilation through a thin endotracheal tube (OD 4.4 mm) instead of a thick tube (OD 8-11 mm)
2. Higher efficient ventilation by controlling the expiration, where during conventional ventilation the uncontrolled expiration results in alveolar collapse (atelectasis).
3. Ventilation with less energy dissipation (â€˜softer ventilationâ€™) as compared to conventional ventilation techniques, which may induce lung damage.

At the start of the project FCV technology had been on the market for over five years in its most basic form: the manual, disposable emergency ventilator Ventrain. Sold by 16 distributors in 20 countries. At that time the mechanical ventilator (Evone) providing FCV was in development phase at TLR6. The aim of the project was to bring this device from TLR6 to TRL9 and to demonstrate proof of significant clinical benefit of ventilation using Evone, resulting in reduction of overall healthcare cost to increase and speed up its global market-uptake.

Six milestones were defined in the project:
1. Prototype performs well in pig study in Operating Room- TLR7. (achieved 15 April 2016)
2. 1st version Evone CE marked- TLR8 (achieved 09 August 2017)
3. Evone FDA cleared (still ongoing)
4. Clinical benefit by demonstrating (TLR9):
A safe and proper ventilation using Evone in â€œgeneral patientsâ€ (achieved April 2018)
B significant clinical benefit in three specific patient populations (achieved Nov 2018)
5. Life cycle management system running: technical aftersales service, updates, repairs (Jan 2018)
6. Acceptance by â€˜Innovatorsâ€™, KOLâ€™s, demonstrated by first sales (achieved Nov 2018)

During the project in-vivo studies showed increased ventilation efficiency and lung protective potential as compared to VCV.
By the end of the project Evone has been used in over 300 patient cases in more than 30 hospitals in 10 countries. Randomised controlled trials confirmed safe and adequate patient ventilation and revealed significant clinical benefit. This evidence is key to enhance sales by our distributors across Europe, who are ready to demonstrate and sell Evone.

Note: EVA, Evone, FCV, Tritube, Ventrain, are registered trademarks.

Work performed

A prototype of Evone (EVA device) providing FCV was developed and tested in a clinically relevant setting in healthy pigs and pigs with diseased lungs. A safe and adequate ventilation for 6 hours and 3 hours respectively, was demonstrated, marking the achievement of Milestone 1 of this project (TRL7).
Moreover a higher efficient ventilation with protective potential was demonstrated an published (Schmidt et al EJA 2018). In lung diseased pigs FCV was again demonstrated higher efficient than VCV, but also more lung protective. This study was awarded â€˜Best Abstractâ€™ at Euroanaesthesia 2018.

To create acceptance and awareness the Evone prototype (at TRL6 and TRL7) was demonstrated at a.o. the World Airway Management Meeting 2015 (Dublin), at Euroanaesthesia 2016 (London), 2017 (Geneva) and at the Cutting Edge Laryngology Conference 2016 (London), European airway Management congress 2017 (Berlin), ORL-HNS congress 2017 (Barcelona). End user feedback was gathered for device improvements and a first step in acceptance by end users and KOLs was herewith initiated.
Further, at Euroanaesthesia 2017 a large Industry symposium was organized and chaired by Prof. Dr. med. Hartmut Buerkle from Freiburg and Prof. Dr. Gilles Dhonneur from Paris. Three Key Opninon Leaders (Prof. Dr. Carin Hagberg, Prof. Dr. Luciano Gattinoni and Prof.Dr. med. Dietmar Enk) explained the FCV technology and elucidated on related (potential) clinical benefits.

CE marking was obtained in August 2017 (Milestone 2 of the project), allowing first clinical use of the device.
Contacts with KOLs and anesthesiologists obtained a.o. at the above mentioned conferences lead to clinical demonstrations in several hospitals in different countries. Well-over 300 patient cases in more than 30 hospitals in 10 countries across Europe were performed during the project. These cases revealed safe and efficient ventilation performance of Evone in these highly variable patients. Gained feedback was used to further improve the device where needed.

Clinical studies were executed, which aimed to evaluate Evoneâ€™s ventilation performance and potential clinical benefit in the â€˜generalâ€™ population and in specific patients groups. The studies revealed clear benefits, which are to be presented and published on scientific congresses and in journals (Milestone 4).

In January 2018 the first Evone was sold to the VUmc (Amsterdam, the Netherlands). Ventinova had established the life cycle management system (milestone 5). To further enhance sales across Europe distributors in 13 countries were selected, trained and supplied to enable them to demonstrate and sale the device. By the end of the project, devices were sold to Spain, Italy, France, Austria, UK, the Netherlands and Turkey (Milestone 6).

FDA clearance (Milestone 3) was not achieved during the project.

Note: EVA, Evone, FCV, Tritube, Ventrain, are registered trademarks.

Final results

In-vivo studies clearly revealed an increased ventilation efficiency and lung protective potential. The fact that only a small lumen endotracheal tube Tritube, (OD 4.4 mm and ID <3 mm) was used to efficiently ventilate demonstrates the innovative and ground breaking character of this new ventilation technique.
The EVA consortium has always been convinced that the FCV technology is the solution for specific unmet clinical needs in several medical market segments. The first results confirm our hypotheses regarding clinical benefits of FCV ventilation in specific patient groups:
Most obviously, patients undergoing upper airway surgery will benefit due to the reduced endotracheal tube size, providing significantly more view and working space for the surgeon. Also, the smaller tube may enhance faster intubation and reduce intubation associated tracheal/laryngeal trauma.
Patients who generally suffer from alveolar collapse during mechanical ventilation (e.g. obese patients) may benefit from the controlled expiration provided by Evone.
In the future FCV ventilation may prevent morbidity and mortality in ICU, where mechanical ventilation leads to increased lung damage, worsening patient outcome.
Evaluation of clinical benefit and safety in specific surgical patient groups was evaluated in the H2020 EVA project. The results will be presented at scientific congresses and in peer-reviewed scientific journals.

Note: EVA, Evone, FCV, Tritube, Ventrain, are registered trademarks.