Since 2008 Ventinova Medical BV has been working on the innovative ventilation technique that redefines patient ventilation: Flow Controlled Ventilation (FCV®). FCV® is unique providing a smooth and stable gas flow into or out of the lungs to generate linear increases and decreases in tracheal pressures and to keep the ventilation cycle fully dynamic.
Ventilator Evone® (CE marked in 2017) provides FCV®. Clinical trials and over 2,000 patient cases have underlined the better ventilation capacity and lung protective potential of FCV®: it increases the functional lung by providing a better and more homogenous aeration of the lung and by reducing atelectasis. This results in a better gas exchange with minimized energy dissipation, which is key in the compromised patient (e.g. severy ill ARDS, reduced lung mechanics).
FCV® allows ventilation using conventional tubes and enables to use the ultrathin endotracheal tube Tritube® (ID 2.4 mm). It provides an easy access to the airway and an unprecedented view for the laryngeal surgeon. Tritube minimizes aerosol generation by sealing the trachea with a cuff.
Please refer to our regular literature page for an extensive overview on publications regarding our products.
Airway stenosis – challenges and solution
COVID-19 patients admitted to the ICU often require prolonged mechanical ventilation. The European Laryngological Society has issued an important statement, alerting clinicians for an unprecedented increase of laryngo-tracheal stenosis (LTS)1.
COVID-19 has made safe performance of airway procedures a challenge, for diagnosis as well as treatment. It requires preparedness for prevention and timely management of LTS, with special attention to infection control.
The current strategies to manage the compromized airway include jet ventilation, high flow nasal oxygenation, tracheotomy and ECMO. While the first two options are minimally invasive, aerosols are generated and spread, also ventilation may be less effective in specific patients (e.g. obese). The opposite counts for the latter two options: tracheotomy and ECMO are highly invasive techniques with less aerosol generation and adequate ventilation.
Tritube® is an ultrathin endotracheal tube (OD 4.4mm) with a cuff. It provides a minimally invasive intubation in the compromized airway2,3, provides a great surgical exposure2–6, reduces aerosol generation and spread, and enables highly effective ventilation using Evone®,6. As such Tritube and Evone were found key tools in managing the infraglottic difficult airway in the setting of the Coronavirus pandemic.8
Tritube and Evone – supporting evidence
Case report: Post-COVID-19 patient tracheal stenosis
A Post-COVID-19 patient presented with severe tracheal stenosis. While the ECMO team was standby Dr Nabil Shallik managed to successfully intubate and ventilate this patient with Tritube and Evone. Tritube provided the surgeons the workspace they needed, with minimized aerosol generation.
The video demonstrates:
- Field of interest examination on the airway and guidewire placement under spontaneous ventilation
- Advancing Tritube over the guidewire
- First time balloon dilatation
- Removal of fibrous tissue
- Second time balloon dilatation
- Near normal tracheal shape and size
Tritube and Evone - clinical benefits
Ample clinical data clearly demonstrated clear benefits of using Tritube and Evone, managing the difficult airway or during laryngeal surgery. The following benefits were found:
- Minimized contamination risk for healthcare professionals, due to a sealed airway8
- An unprecedented view of the intubated airway, due to the thin lumen 2,5,6
- A large surgical exposure and hygienic and clear sight with non-moving vocal cords 2,4–6
- Easy intubation even in difficult airways due to the small outer diameter and malleable stylet 2,3,9
- Awake intubation in patients with a difficult airway 2,9
- Well tolerated when left in situ postoperatively, allowing patients to breathe and talk 2,3,9
- More efficient ventilation, better oxygenation and CO2 removal7,10,11
- Piazza, C. et al. Long-term intubation and high rate of tracheostomy in COVID-19 patients might determine an unprecedented increase of airway stenoses: a call to action from the European Laryngological Society. European archives of oto-rhino-laryngology: official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS): affiliated with the German Society for Oto-Rhino-Laryngology – Head and Neck Surgery (2020) doi:10.1007/s00405-020-06112-6.
- Kristensen, M. S., de Wolf, M. W. P. & Rasmussen, L. S. Ventilation via the 2.4 mm internal diameter Tritube® with cuff – new possibilities in airway management. Acta Anaesthesiol Scand 61, 580–589 (2017).
- Kristensen, M. S. & Abildstrøm, H. H. Endotracheal video-laryngoscope guided intubation with a 2.4 mm cuff’ed tube and active expiration by a dedicated ventilator versus a standard tube/ventilator. A randomized single blinded study in patients with a predicted difficult airway. – A paradigm shift in airway management? Abstract published at Euroanaesthesia 2019 3755, (2019).
- Schmidt, J. et al. Flow-controlled ventilation during ear, nose and throat surgery: A prospective observational study. Eur J Anaesthesiol 36, 327–334 (2019).
- Schmidt, J. et al. Glottic visibility for laryngeal surgery: Tritube vs. microlaryngeal tube: A randomised controlled trial. Eur J Anaesthesiol 36, 963–971 (2019).
- Meulemans, J. et al. Evone® Flow-Controlled Ventilation During Upper Airway Surgery: A Clinical Feasibility Study and Safety Assessment. Front. Surg. 7, (2020).
- Schmidt, J. et al. Improved lung recruitment and oxygenation during mandatory ventilation with a new expiratory ventilation assistance device: A controlled interventional trial in healthy pigs. Eur J Anaesthesiol 35, 736–744 (2018).
- Nouraei, S. A. R., Girgis, M., Shorthouse, J., El-Boghdadly, K. & Ahmad, I. A multidisciplinary approach for managing the infraglottic difficult airway in the setting of the Coronavirus pandemic. Operative Techniques in Otolaryngology-Head and Neck Surgery 31, 128–137 (2020).
- Jeyarajah, K. & Ahmad, I. Awake tracheal placement of the Tritube® under flexible bronchoscopic guidance | Case Studies. Anaesthesia Cases 2018–0097, (2018).
- Weber, J., Schmidt, J., Straka, L., Wirth, S. & Schumann, S. Flow-controlled ventilation improves gas exchange in lung-healthy patients— a randomized interventional cross-over study. Acta Anaesthesiologica Scandinavica 64, 481–488 (2020).
- Schmidt, J. et al. Flow-Controlled Ventilation Attenuates Lung Injury in a Porcine Model of Acute Respiratory Distress Syndrome: A Preclinical Randomized Controlled Study. Critical Care Medicine 48, e241–e248 (2020).
Ventinova will regularly share clinical experiences doctors are having while ventilating COVID-19 patients with our ventilator Evone.
Is there aerosol spreading during ventilation using Tritube and Evone?
No, Tritube is an ultrathin endotracheal tube with cuff. The cuff prevents the aerosols from spreading
How do I ventilate through Tritube?
Tritube can be used for ventilating together with Evone for up to 72 hours of safe and efficient FCV ventilation. During ventilation intratracheal pressures should be measured via the pressure measurement lumen. Cuff pressures should be intermittently monitored and corrected when needed.
Further tritube can be used with Ventrain, our manual small lumen ventilator. Ventrain is intended to be used for 30 minutes maximally. Of note, while using Ventrain exhausted gas (and potentially blood and secretions) exits via the thumb whole. Therefore Ventrain carries the risk of contamination as it spreads aerosols.
Is it possible to intubate awake patients with Tritube?
Yes this is possible. This has already been done as normal endotracheal intubation as well as nasal intubation.
For movies about this subject click here http://airwaymanagement.dk/171/index.php?option=com_content&view=article&id=27&Itemid=324)
Is Tritube laser resistant?
No Tritube is not laser resistant
What makes Tritube special?
Tritube knows a revolutionary combination of characteristics:
- an ID of ~2.3 mm and an OD of only 4.4 mm, providing easy access to the airway and a spacious surgical site.
- an HVLP inflatable cuff to secure the airway with lower lateral wall pressures.
- made of polyurethane, resulting in an ultrathin cuff, which requires less cuff pressure to seal the trachea and a strong and flexible tubing.
- a separate pressure measurement lumen, which allows continuous or intermittent monitoring of the intratracheal pressure.
- a malleable stylet, which allows Tritube to be bent in any shape for easy endotracheal access.
- allows adequate ventilation of an adult patient using Evone®
Download quick reference cards
Download Instructions for Use
Download quick reference cards ICU
Dowload Instructions for Use
Animation Evone (ICU version)
Dutch Ministry of Health also opts for Evone® by Ventinova from Eindhoven Results of FCV®-equipped ventilation equipment appears promising Eindhoven, 2 April 2020 – Ventinova Medical, a company based in Eindhoven, received good news today; this concerns...