First COVID-19 ICU patients ventilated with Evone show promising results
Many thanks to all medical professionals
We are dealing with an extraordinary public healthcare challenge. We would like to thank all medical professionals for your commitment, and caring for patients in this fight against COVID-19. Your courage to help these patients in the face of this global pandemic is inspirational.
Clinical experience
Ventinova Medical BV is a Dutch company specialised in innovative ventilation products. The company has been working on the disruptive ventilation method FCV® since 2008. This resulted in marketing of the manual ventilator Ventrain in 2010, offering a basic form of FCV®, followed by CE marking of the mechanical ventilator Evone in 2018, enabling the complete FCV® concept. This technology uniquely controls both the inspiratory and expiratory phases of patient ventilation, which has proven to offer several clinical benefits.
Clinical evidence of Evone:
- 4 controlled studies;
- 1 observational study;
- 1 retrospective study;
- Over 2000 patient cases including published case reports;
- 3 randomised controlled animal studies.
Please refer to our regular literature page for an extensive overview on all publications regarding our products.
FCV® – as compared to conventional ventilation methods – has been shown to provide a more homogenous aeration of the lungs while reducing atelectasis, resulting in a higher ventilation efficiency and an improved lung function. Furthermore, the energy dissipation into the lungs has been suggested to be reduced during FCV®. Although published clinical data has been mostly obtained in an operating room (OR) setting and our experiences on the intensive care unit (ICU) are still limited, the present body of evidence suggests that the demonstrated advantages of FCV® can be equally transferred to an ICU setting. Especially severely ill ARDS patients are likely to benefit from a gentle, yet higher efficient ventilation strategy with minimized energy dissipation to avoid ventilator-induced lung injury and support recovery of the lungs. To date, the first observations on Covid-19 patients look promising.
We would like to work together with the field to gather more clinical evidence in an ICU setting.
Background - Current strategies
Severe progression of COVID-19 pneumonia comprises the rapid development of acute respiratory distress syndrome (ARDS), rendering mechanical ventilation an essential part of supportive treatment for critically affected patients.1,2 As researchers and medical experts are just at the beginning to understand the underlying pathophysiological mechanisms of this novel disease, current ventilatory strategies are mainly in line with existing recommendations for other patients with acute respiratory failure on the intensive care unit (ICU).1 Based on the main goal to minimize ventilator-induced lung injury (VILI),3 these strategies include the application of low tidal volumes, limited plateau pressures, and a positive end-expiratory pressure (PEEP) >10 cmH2O.1 Recruitment maneuvers may be indicated in cases of persisting hypoxemia, although signs of barotrauma and hypotension need to be strictly monitored.1 Moreover, prone positioning of the patient may help to achieve more homogenous ventilation of the lungs in cases of moderate or severe ARDS, while carrying certain disadvantages such as the risk of endotracheal tube dislocation and pressure sores.1 Finally, venovenous extracorporeal membrane oxygenation (VV-ECMO) may be considered a last option in case optimization of ventilation and rescue maneuvers fail.1
However, as ongoing research suggests that COVID-19 ARDS may be different from well-described forms of the syndrome and thus require specific therapeutic measures, the most promising ventilation strategy for affected patients still needs to be defined.
Evone for COVID-19 patients
Current status
We currently have data of seventeen COVID-19 patients with severe ARDS that have received, or are still receiving ventilation with Evone.
The first observations are very encouraging:
- Already within the first 24-30 hours of FCV ventilation the Horowitz index – an important measure for the effectiveness of ventilation of a patient – showed a clear increase ranging from 60% to 150% in five patients
- These patients could be normoventilated in supine position and without the need for recruitment maneuvers
Note: For several patients data is not yet available, another patient unfortunately passed away due to severe cardiac problems. Detailed data is being treated confidentially by the respective hospitals.
Although these results are preliminary and require further validation, they are perfectly in line with already described effects of FCV in ARDS:
- Ventilation by Evone was applied for rescue of patient with severe ARDS4
- FCV reduced lung damage in porcine ARDS5
- FCV results in higher efficient ventilation, improved lung recruitment and more homogenized lung aeration than conventional ventilation methods5,6
- FCV can be applied to individually optimize ventilation and improve lung compliance4,6
“For further clinical validation of the use of Evone in COVID-19 patients we depend on your support! Please share your experiences with us to make them available for the medical community. Also, you can always contact us regarding questions on Evone and FCV via info@ventinova.nl”
Evone in ARDS – Supporting evidence
Case report: FCV applied for rescue of patient with severe ARDS (Ref.4)
Summary:
- 22 year old male patient with traumatic brain injury and chest trauma admitted to ICU; P/F ratio 49 mmHg
- Conventional strategies (VCV and lateral rotational therapy) did not improve respiratory parameters; ECMO was contraindicated
- FCV was started and settings were individually optimized based on respiratory system compliance
- Significant lung improvement within few hours: P/F ratio 177, 270 and 397 mmHg after 1, 12 and 24 hours, respectively
- Chest radiographs showed improved lung condition
- Patient entered weaning procedure after in total 77 hours FCV ventilation
- Discharged two weeks later in favorable condition
Randomized controlled study: FCV attenuated lung injury and allowed improved lung recruitment and higher efficient ventilation in porcine ARDS (Ref.5)
Summary:
- 3 hours of FCV compared to VCV, with similar PEEP, Peak, tidal volume and respiratory rate
- FCV improved oxygenation by 47% while using a 26% lower minute volume
- FCV showed decreased signs of alveolar lung damage
- FCV resulted in significantly more normally aerated and less non-aerated lung tissue compared to VCV
See movies of dynamic CT scans here:
FCV
VCV
Randomized controlled study: FCV attenuated lung injury and allowed improved lung recruitment and higher efficient ventilation in porcine ARDS (Ref.5)
Summary:
- 3 hours of FCV compared to VCV, with similar PEEP, Peak, tidal volume and respiratory rate
- FCV improved oxygenation by 47% while using a 26% lower minute volume
- FCV showed decreased signs of alveolar lung damage
- FCV resulted in significantly more normally aerated and less non-aerated lung tissue compared to VCV
|
See movies of dynamic CT scans here: FCV VCV |
Evone – Clinical benefits
- Safety and performance of FCV for ventilation of lung-healthy patients demonstrated in observational and randomised controlled studies
- FCV provides higher efficient ventilation, more homogenous lung recruitment, better lung aeration, and ventilation with lower energy dissipation than VCV or PCV
- For details and links to all publications see https://www.ventinovamedical.com/literature/ and https://www.ventinovamedical.com/evidence/
References
- Alhazzani W, Møller MH, Arabi YM, et al. Surviving Sepsis Campaign: Guidelines on the Management of Critically Ill Adults with Coronavirus Disease 2019 (COVID-19). Intensive Care Medicine. 2020:104.
- Fan E, Brodie D, Slutsky AS. Acute Respiratory Distress Syndrome: Advances in Diagnosis and Treatment. JAMA. 2018;319(7):698-710. doi:10.1001/jama.2017.21907
- Slutsky AS, Ranieri VM. Ventilator-induced lung injury. N Engl J Med. 2014;370(10):980. doi:10.1056/NEJMc1400293
- Bergold et al. WAMM 2019. Flow-controlled ventilation: A novel approach to treating severe acute respiratory distress syndrome. Link to e-poster: https://epostersonline.com/wamm2019/node/1498?view=true
- Schmidt et al. Flow-Controlled Ventilation Attenuates Lung Injury in a Porcine Model of Acute Respiratory Distress Syndrome: A Preclinical Randomized Controlled Study. Crit Care Med 2020; 48:e241–e248. Link to full publication: https://journals.lww.com/ccmjournal/Fulltext/2020/03000/Flow_Controlled_Ventilation_Attenuates_Lung_Injury.36.aspx
- Unpublished data, oral communication: Randomized porcine study comparing optimized FCV versus PCV in porcine ARDS. Manuscript in preparation.
Ventinova will regularly share clinical experiences doctors are having while ventilating COVID-19 patients with our ventilator Evone.
FAQ’s
Does Evone have CE mark for usage in the ICU?
Yes. Evone is intended to be used in elective procedures for less then 72 hours without the need for inhaled anesthetic agents, in operating rooms and intensive care environments.
What are the advantages of Evone in the ICU?
Currently, there are no randomised controlled studies available assessing ventilation with Evone in an ICU environment. However, there is a body of evidence from preclinical and clinical studies and other data indicating (potential) benefits that will likely also apply in an ICU environment:
Compared to conventional ventilation modes, FCV mode by Evone
- Provides ventilation with higher efficiency (e.g. allows normocapnia with lower minute volumes)
- Allows more homogenized aeration of the lungs and improved lung recruitment, especially in dependent lung areas
- Reduces energy dissipation into the lungs and might therefore represent a method for lung-protective ventilation
What are the disadvantages of Evone in the ICU?
- Evone is currently not able to be connected to a Patient Data System/Central Alarming. Ventinova is currently working on making this possible. Thus, Evone needs to be operated by or under the direct and constant supervision of an anesthetist or intensivist.
- Because of the high resistance of the breathing circuit, spontaneous breathing of the patient is not possible when connected to Evone. Therefore, Evone should only be used in patients under total intravenous anesthesia (TIVA), and sedation should be monitored closely. As a result, Evone cannot be used for weaning the patient. To wean a patient a conventional ventilator needs to be used.
Can Evone ventilate via conventional endotracheal tubes?
Yes, via the Evone Conventional Tube adapter Evone can be connected to a conventional endotracheal tube.
Can I use any HME filter?
No, many filters have larger dead volumes then preferred. The Humid-Vent Filter Pedi straight (Teleflex Medical) is the only filter for which compatibility is claimed.
Despite the small tidal volume communicated for the advised filter this is approved to use in combination with Evone. Considering the larger „adult“ tidal volumes applied through the „pediatric“ HME-filter, it has to be emphasized that the bidirectionally used ventilation tubing also acts as an artificial nose. Please note the condensation of water in the ventilation tubing next to the patient. Based on (extrapolation of) in-vitro measurements the overall perspiratory loss of water during ventilation with Evone with the „pediatric“ HME-filter attached calculates to less than 250 ml/24 hours. Evone has been certified for the use of a „pediatric“ filter. It mainly acts as a viral and bacterial filter to protect the cartridge and also removes water droplets from the ventilation tubing which make it to the HME-filter. For this reason the HME-filter is mounted slightly oblique.
Do virusses get into the surrounding due to the expiration?
Expiratory flow goes through a viral/bacterial filter, the same as other respirators.
Is it possible to use closed suctioning while the patient is connected to Evone?
Yes, it is possible. For instruction on the setup, please click here . For the actual procedure click here.
Please note that a size 7.5 mm ID endotracheal tube or larger is needed to keep the pressure line of the Conventional Tube Adapter CTA in place (this is in combination with a 14 Fr suction catheter).
Can I use inhalation anesthetics?
Evone can only be used in combination with TIVA. Evone is not an anesthesia machine, but a sole patient ventilator and thus does not provide anesthetic gas. Furthermore, the ventilation circuit is not a closed system. It is also very important to keep the patient deep asleep as there is no possibility for the patient to breath spontaneously.
How often do I have to change the Evone cartridge?
We advise to change the Evone cartridge every 72 hours. For the procedure to change the cartridge, please click here.
How often do I have to change the HME-filter and what is the procedure?
We advise to change the filter every 24 hours. For the procedure to change the HME filter, please click here.
Are there clinical studies available regarding the use of Evone?
Yes, there are clinical studies available. For more information see our literature page and evidence page.
Documents
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Quick Reference Card Evone ICU
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Quick Reference Card Evone ICU
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Instructions for Use Evone
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Instructions for Use Evone
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Instructions for Use Evone
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Instructions for Use Evone
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Instructions for Use Evone
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Instructions for Use Evone
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Instructions for Use Evone | English
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Instructions for Use Evone | French
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Animation Evone (ICU version)
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