“FCV keeps the lung open in a very smooth way”
Prof. Dr. med. Dietmar Enk
Inventor/Anesthesiologist/Intensivist, University Münster, Germany
Keeping the lung open – a key strategy to prevent postoperative pulmonary complications
Postoperative Pulmonary Complications (PPCs)
- Major cause of death after (non-) cardiothoracic surgery 9-12
- Lead to longer hospital stays and increased mortality rates 1-3,11,13,14
- Up to one in five patients who develops severe PPC dies within 30 days of surgery 3
- Incidence varies between surgical procedures:
– 5–10% after general surgeries 3,13,14
– 30–40% after abdominal and intrathoracic surgeries 1,3,13
– 87% after liver transplantation 15
Approaches to reduce PPC development
- Intraoperative desaturation, likely due to atelectasis and airway closure, is significantly associated with PPCs 14
- Current ventilation strategies aim to keep the lung open
– Using positive end-expiratory pressure (PEEP)
– Using recruitment maneuvers
- Diverging results from studies on patient outcome 23-30
- Ongoing trials evaluate strategies to effectively keep the lung open 31,32
FCV® is ventilation with higher efficiency
Improved regional ventilation in obese patients by FCV®
The first clinical study comparing ventilation of obese patients with FCV® vs VCV was published in BMC Anesthesiology by Weber et al. With comparable tidal volumes and lower peak pressures, FCV® better maintained end-expiratory lung volume as compared to VCV (P<0.001) during only seven minutes of ventilation, respectively. This strongly indicates that the constant expiratory flow during FCV®, in combination with an elevated mean intratracheal pressure, has a recruiting effect and may help to prevent atelectasis often occurring during ventilation of obese patients. Read article.
FCV® beneficial during one lung ventilation of COPD patient
A COPD patient undergoing open thoracic surgery for esophageal resection was successfully ventilated with Evone. Ventilation with FCV® led to very stable respiratory parameters: with an FiO2 (fraction of inspired oxygen) of only 30%, an oxygen saturation of 99-100% was maintained throughout large phases of the intervention. The anesthetists appreciated the benefits of FCV®: “With conventional ventilation, usually an FiO2 of 80% would be required to reach comparable saturation.” Meanwhile, the surgeons were satisfied with the calm operation field: “It seems as if nothing is moving!”
FCV® adequately ventilated one lung in challenging patient case
Prof. Dr. med. Arnd Timmermann, Chefarzt Anesthesiology, DRK Kliniken Berlin | Westend und Mitte, Germany, used Evone in a special case of one lung ventilation. Surgical removal of a large thoracic wall tumor required ventilation of only the right lung, which was significantly reduced in size due to a previous medical condition. Using Tritube inside a double lumen tube, the right lung was adequately ventilated with FCV®, while the patient remained stable throughout the procedure. The surgeon: “Absolutely smooth movements of the ventilated lung and the heart, which does not disturb my operation field.”
FCV®– a new ventilation concept
- Is based on continuous inspiratory and expiratory flow 33
- Has no notable pauses during ventilation 33
- Aims for a linear increase and decrease in intratracheal pressure 33
- Has been applied clinically in more than 40 hospitals across 11 countries
- Has been applied successfully in multicenter observational study 37 and four randomized controlled trials (funded by the European Union’s Horizon 2020 research and innovation program under grant agreement no. 691519) 38-41
FCV® by Evone
- Keeps the lung open by controlling the full ventilation cycle 35,36
- Results in better lung recruitment as compared to VCV 35,36,38,39
- Results in better aeration of the lungs as compared to VCV 35,36,39
- Provides higher ventilation efficiency as compared to VCV, evidenced by improved oxygenation and CO2 removal 35,36,40
- Reduces atelectasis in dependent lung parts as compared to VCV in porcine ARDS 36 and morbidly obese patients 39
- Mazo V, Sabaté S, et al. Prospective external validation of a predictive score for postoperative pulmonary complications. Anesthesiology. Anesthesiology. 2014 Aug;121(2):219-31.
- Serpa Neto A, Hemmes SN, et al. Incidence of mortality and morbidity related to postoperative lung injury in patients who have undergone abdominal or thoracic surgery: a systematic review and meta-analysis. Lancet Respir Med. 2014;2:1007–15.
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- Canet J, Sabaté S, et al. Development and validation of a score to predict postoperative respiratory failure in a multicentre European cohort: a prospective, observational study. Eur J Anaesthesiol. 2015;32:458–70.
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- Weiser TG, Makary MA, et al; Standardised metrics for global surgical surveillance. Lancet. 2009;374:1113–7.
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- Rahmanian PB, Kröner A, Langebartels G, Özel O, Wippermann J, Wahlers T. Impact of major non-cardiac complications on outcome following cardiac surgery procedures: logistic regression analysis in a very recent patient cohort. Interact Cardiovasc Thorac Surg. 2013 Aug;17(2):319-26; discussion 326-7. doi: 10.1093/icvts/ivt149. Epub 2013 May 10. PubMed PMID: 23667066; PubMed Central PMCID: PMC3715168.
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- Khuri SF, Henderson WG, DePalma RG, Mosca C, Healey NA, Kumbhani DJ; Participants in the VA National Surgical Quality Improvement Program. Determinants of long-term survival after major surgery and the adverse effect of postoperative complications. Ann Surg. 2005 Sep;242(3):326-41; discussion 341-3. PubMed PMID: 16135919; PubMed Central PMCID: PMC1357741.
- LAS VEGAS investigators. Epidemiology, practice of ventilation and outcome for patients at increased risk of postoperative pulmonary complications: LAS VEGAS – an observational study in 29 countries. Eur J Anaesthesiol. 2017 Aug;34(8):492-507. doi: 10.1097/EJA.0000000000000646. PubMed PMID: 28633157; PubMed Central PMCID: PMC5502122.
- De Gasperi Feltracco P, Ceravola E, Mazza E. Pulmonary complications in patients receiving a solid-organ transplant, Crit Care 2014; 20 (4) 411-419.
- McAlister FA, Bertsch K, Man J, Bradley J, Jacka M. Incidence of and risk factors for pulmonary complications after nonthoracic surgery. Am J Respir Crit Care Med. 2005 Mar 1;171(5):514-7. Epub 2004 Nov 24. PubMed PMID: 15563632.
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- Canet J, Gallart L. Predicting postoperative pulmonary complications in the general population. Curr Opin Anaesthesiol. 2013 Apr;26(2):107-15. doi: 10.1097/ACO.0b013e32835e8acd. Review. PubMed PMID: 23407154.
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- Riss S, Mittlböck M, Riss K, Chitsabesan P, Stift A. Intraoperative complications have a negative impact on postoperative outcomes after rectal cancer surgery. Int J Surg. 2014;12(8):833-6. doi: 10.1016/j.ijsu.2014.07.003. Epub 2014 Jul 9. PubMed PMID: 25014647.
- O’Gara B, Talmor D. Perioperative lung protective ventilation. BMJ. 2018 Sep 10;362:k3030. doi: 10.1136/bmj.k3030. Review. PubMed PMID: 30201797.
- PROVE Network Investigators for the Clinical Trial Network of the European Society of Anaesthesiology, Hemmes SN, Gama de Abreu M, Pelosi P, Schultz MJ. High versus low positive end-expiratory pressure during general anaesthesia for open abdominal surgery (PROVHILO trial): a multicentre randomised controlled trial. Lancet. 2014 Aug 9;384(9942):495-503. doi: 10.1016/S0140-6736(14)60416-5. Epub 2014 Jun 2. PubMed PMID: 24894577.
- Treschan TA, Kaisers W, Schaefer MS, Bastin B, Schmalz U, Wania V, Eisenberger CF, Saleh A, Weiss M, Schmitz A, Kienbaum P, Sessler DI, Pannen B, Beiderlinden M. Ventilation with low tidal volumes during upper abdominal surgery does not improve postoperative lung function. Br J Anaesth. 2012 Aug;109(2):263-71. doi: 10.1093/bja/aes140. Epub 2012 Jun 1. PubMed PMID: 22661750.
- Sundar S, Novack V, Jervis K, Bender SP, Lerner A, Panzica P, Mahmood F, Malhotra A, Talmor D. Influence of low tidal volume ventilation on time to extubation in cardiac surgical patients. Anesthesiology. 2011 May;114(5):1102-10. doi: 10.1097/ALN.0b013e318215e254. PubMed PMID: 21430518; PubMed Central PMCID: PMC3500383.
- Unzueta C, Tusman G, Suarez-Sipmann F, Böhm S, Moral V. Alveolar recruitment improves ventilation during thoracic surgery: a randomized controlled trial. Br J Anaesth. 2012 Mar;108(3):517-24. doi: 10.1093/bja/aer415. Epub 2011 Dec 26. PubMed PMID: 22201185.
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- English translation “Method and device for ventilating a patient”, D. Enk. Priority March 2016
- Wirth S, Springer S, Spaeth J, Borgmann S, Goebel U, Schumann S. Application of the Novel Ventilation Mode FLow-Controlled EXpiration (FLEX): A Crossover Proof-of-Principle Study in Lung-Healthy Patients. Anesth Analg. 2017 Oct;125(4):1246-1252.
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- Schmidt J, Günther F, Weber J, Wirth S, Brandes I, Barnes T, Zarbock A, Schumann S, Enk D. Flow-controlled ventilation during ear, nose and throat surgery. A prospective observational study. Eur J Anaesthesiol. ePub 2019 Feb 5.
- Schmidt J, Günther F, Weber J, Wirth S, Schumann s. Improved airway management and ventilation with a cuffed endotracheal tube with an outer diameter of 4.4 mm for laryngeal surgery – a randomized controlled trial. Euroanaesthesia 2019, Abstract 3269.
- Weber J, Straka L, Schmidt J, Borgmann S, Wirth S, Schumann S. Flow-controlled ventilation improves end-expiratory lung volume in obese patients – a crossover controlled interventional trial. Euroanaesthesia 2019, Abstract 3315.
- Weber J, Schmidt J, Straka LMM, Wirth S, Schumann S. Flow-controlled ventilation improves oxygenation in mechanically ventilated lung-healthy patients – a crossover controlled interventional trial. Euroanaesthesia 2019, Abstract 3301.
- Kristensen MS, Abildstrøm HH. 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? Euroanaesthesia 2019, Abstract 3755.
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Eindhoven, 09 March 2022 – The supervisory board of Ventinova Medical is pleased to announce that Hubert Thomassen is the new CEO. Ventinova Medical is a MedTech company that has introduced an innovative and patented ventilation technique that redefines patient...