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.

Current status

Update 26-Mar-2019

We are currently aware of eight 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 respiratory status 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: While for one patient data is not yet available, another patient unfortunately passed away due to severe cardiac problems. No adverse effects of application of Evone have been reported. 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 methods^5,6
• FCV can be applied to individually optimize ventilation and improve lung compliance^4,6

^{“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”}

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

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

https://d047c2cddb.site.internapcdn.net/permalink/ccm/f/ccm_48_3_2019_12_04_schmidt_ccmed-d-19-00704_sdc2.mp4

VCV

https://d047c2cddb.site.internapcdn.net/permalink/ccm/f/ccm_48_3_2019_12_04_schmidt_ccmed-d-19-00704_sdc3.mp4

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 https://d047c2cddb.site.internapcdn.net/permalink/ccm/f/ccm_48_3_2019_12_04_schmidt_ccmed-d-19-00704_sdc2.mp4 VCV https://d047c2cddb.site.internapcdn.net/permalink/ccm/f/ccm_48_3_2019_12_04_schmidt_ccmed-d-19-00704_sdc3.mp4

• 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/

1. 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.
2. 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
3. Slutsky AS, Ranieri VM. Ventilator-induced lung injury. N Engl J Med. 2014;370(10):980. doi:10.1056/NEJMc1400293
4. 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
5. 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
6. Unpublished data, oral communication: Randomized porcine study comparing optimized FCV versus PCV in porcine ARDS. Manuscript in preparation.