i o a t t i l e n I R A T O R v e S P s i R E v a I n vylife Boussignac Just Breathe N o

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1 S P s i v e V Y e n I R A T O R t i l a t i o n R E v a I n n N o vylife Boussignac Just Breathe

2 What is vylife Boussignac? vylife Boussignac is an emergency and transport breathing apparatus. This Non Invasive Ventilation (NIV) device supplies 3 ventilation modes: controlled ventilation (APNEA mode), non invasive ventilation with 2 levels of pressure (NIV-2P mode), and non invasive ventilation with continuous positive airway pressure (CPAP mode). How does vylife Boussignac work? The operating principle of vylife Boussignac is simple as it is based on the creation of a virtual valve inside the device just the same way as in Boussignac CPAP. This virtual valve is coupled with the Vylife apparatus (controller module) which pilots it. vylife Boussignac is an open system and works without a mechanical valve. Thus, it adapts continuously to the medical treatment and to the patients physiology, with optimum safety concerning the pressures generated. Oxygen supply Oxygen molecules arrive in a circular chamber from which 4 micro-capillaries exit Oxygen acceleration The oxygen molecules are accelerated as they pass through the 4 micro-capillaries Open to atmosphere Zone of Turbulence Creation of a virtual valve The oxygen molecules collide, generating turbulence which transforms the energy into pressure Pressure in the virtual valve directly depends on the flow rate of gas When you increase the flow rate, you increase the pressure When you decrease the flow rate, you decrease the pressure 2

3 vylife Boussignac vylife Boussignac, 1 device, 3 ventilation modes Controlled ventilation CPAP NIV-2P Controlled ventilation mode Controlled ventilation Transport of intubated patient Mechanical ventilation APNEA Mode Controlled ventilation mode indications: 1. Each patient who needs controlled ventilation 2. Possible adjustments with vylife Boussignac controlled ventilation mode: Pmax: Maximum pressure (different from the peak pressure which is the maximum pressure reached during the active insufflation phase of the inspiratory phase). This adjustment allows inopportune pressure increase to be controlled (ex: patient s cough) Pmin: Minimum pressure Ventilation frequency: it is the repletion frequency of ventilation cycles. A complete ventilation cycle is composed of inspiration and expiration. For an adult patient a complete ventilation cycle occurs around every 5 seconds. vylife Boussignac allows adjusting up to 54 cycles/min. I:E ratio: Inspiration to Expiration ratio It is the ratio of the duration of inspiration to the duration of expiration. During the duration of inspiration the tidal volume is insufflated in the patient s lungs. During the duration of expiration the expiratory valve is open: the tidal volume insufflated in the patient s lungs during the duration of inspiration runs off/gets out. Generally, the duration of expiration is shorter than the duration of inspiration. This adjustment allows the ratios to vary. With vylife Boussignac, following ratios may be adjusted: 3:2 1:1 3:4 2:3 1:2 1:3 1:4 Proven benefits of controlled ventilation with vylife Boussignac Tidal volume (Vt) automatically determined by resistance and patient s lung compliance Open system that limits the agressiveness of mechanical ventilation No mechanical part at the patient s side: vylife Boussignac is MRI compatible Compatible with every type of interface: face mask, supraglottic device (LMA, Fast-trach, Easytube, Combitube) and ET tube 3

4 CPAP mode Continuous Positive Airway Pressure one pressure level Spontaneous ventilation cmh 2 O Insp. DELTA P Exp. DELTA P WOB CPAP 7.5 cmh 2 O Atmospheric pressure Time The Work-of-Breathing (WOB) needs to be reduced for the patient: Boussignac CPAP decreases the WOB The WOB is the expenditure of energy required to inspire air in the lungs. The Delta P is the difference between inspiratory pressure and expiratory pressure. CPAP mode indications: The main indication is for Acute Cardiogenic Pulmonary Edema (ACPE): application of CPAP: 7.5 to 10 cmh2o (1) Willem Dieperink et al. BMC Cardiovascular Disorders 2007 ACPE (Acute Cardiogenic Pulmonary Edema) ACPE Hypoxemia -Alveoli collapsus -Lungs filled with fluid (reduced area of gas exchange) -Increase of WOB Pulmonary volume Alveolar recruitment Improvement of ventilation / perfusion ratio Decrease the WOB Decrease of venous return Decrease of left ventricular afterload CPAP mode Hemodynamic 4

5 Other clinical indications: vylife Boussignac Conscious drowned person: (2) Dottorini M, et al - Chest Acute severe asthma: Boussignac CPAP can be used in conjunction with nebulization: (3) Laurent Brochard et al - Respiratory Care. Oct (4) Service d Aide Médicale d Urgence (SAMU) de Lille: Protocole d utilisation de la CPAP de Boussignac avec nébuliseur. 14 mars 2007 Proven benefits of CPAP mode with vylife Boussignac High FiO2 Rapid hypoxia correction with an increase of SpO 2 Rapid correction of ACPE s clinical signs Patient s tolerance to an open system Intra-hospital treatment Operating room Bariatric surgery, cardiac surgery, thoraco-abdominal surgery: (5)Wong D., et al Can J Anesth Preoperative: pre-oxygenation : (6)Delay J.M., Jaber S. - Presse médicale 2012 Extubation with positive pressure Postoperative: immediately after extubation: (7)Neligan P., et al Anesthesiology Intensive care unit and resuscitation Paediatrics Post-resuscitation: stabilization and weaning after extubation: (8)Dieperink W, et al Respiration Fiberoptic bronchoscopy in hypoxemic patients: (9) Jaber S., et al - Am J Resp Crit Care Med Vol.162, 2000 Infant bronchiolitis: (10) Fleming P.F., et al J Paediatr Child Health Proven benefits of CPAP mode with vylife Boussignac Alveolar recruitment Prevention of atelectasis Improved lung volume Reduced risk of reintubation Decreased length of in-patient hospital stay Proven decreased rate of ventilator associated pneumonia and duration of oxygen requirement without prolonging the hospital stay In addition to the above indications and clinical performances, the controlled ventilation mode triggers automatically after 20 seconds in case of APNEA. 5

6 NIV-2P mode Non Invasive Ventilation with 2 levels of pressure cmh 2 O Insp. IPAP Exp. EPAP Exp. 0 Insp. Time -1 IPAP : Inspiratory Positive Airway Pressure EPAP : Expiratory Positive Airway Pressure Respiratory cycle in NIV-2P EPAP: Expiratory Positive Airway Pressure 2 Inspiratory trigger 3 PS (Pressure Support) = IPAP-EPAP 4 Slope: speed from expiratory pressure to inspiratory pressure 5 IPAP: Inspiratory Positive Airway Pressure 6 Expiratory trigger NIV-2P mode indications Hypercapnic and decompensated Chronic Obstructive Pulmonary Disease (COPD) (11) Brochard L., et al. SRLF 2009 (12), (13) Proven benefits of vylife Boussignac NIV-2P mode: Sensitive and accurate trigger without auto-triggering (12) Meduri Gu and al. Chest 1996 The starting PEP is automatically set at 4cm H2O to go against patient s auto PEP (13) Ram FS and al. Cochrane DatabaseSyst Rev Increased gazometric and ventilator parameters 6

7 vylife Boussignac: What are the features and benefits? vylife Boussignac The Vylife apparatus has a very light weight of 510g The size of a TV remote (19.5cm*7.5cm*3.5cm) Large screen Easy to read ventilation mode, pressures, battery, respiratory frequency Easy-to-use with simple buttons + Increases pressure - Decreases pressure One click connection No risk of misconnection Boussignac CPAP and Nebulization A specific nebulizer fitted with a separate oxygen extension tube, allows an optimum flow rate (6l/min) for drug particles between 2 to 4 μm ensuring a perfect broncho-alveolar spread. FiO 2 ring Nebulizer 7

8 Accurate, sensitive and reliable trigger No risk of auto-triggering The trigger is integrated in the disposable part of the device and not in the apparatus Disposable kit Ready to use Open system No risk of asphyxia Special «star» shaped O 2 tube Reduces the risk of tube kinking and the associated cessation of gas delivery Noise reducer This device reduces the noise by 6 decibels. With the noise reducer Boussignac CPAP now reaches a level of approximatively 69 decibels (=to shower running 70 dcbls). This accessory is optimum for intra-hospital use. 8

9 vylife Boussignac is vylife Boussignac Effective CPAP mode (14), (15) Decrease the WOB Flow rate of gas available for inspiration is 280 to 320 l/min The difference between inspiratory pressure and expiratory pressure (Delta P) is only 1.5 +/- 0.2 cmh2o (16) Valero P., Khoury a., et al. Poster. SRLF-2013 Regulation of inspired FiO2 NIV-2P mode (11), (12) Pressurization quality Accurate and sensitive trigger Safe Open System: if necessary the patient can breathe atmospheric air and thus constantly breathe the required volume of gas Spontaneous ventilation is possible even if the gas flow stops No mechanical parts Precise control of generated pressures with specific manometer No risk of barotrauma / volotrauma: the pressure in the lungs cannot be superior to the one in the CPAP valve thanks for open system No risk of hypoventilation No need to intubate the patient in a hurry: time can be taken to evaluate and diagnose the real need for intubation Trigger integrated in the disposable part of the device for more reliability Possibility to do a bronchoscopy without stopping the treatment in case of severe hypoxemia Easy-to-use Light and intuitive device User-friendly Easy to learn Reduced bulk (510g) for pre-hospital settings Possibility to connect a nebulizer Regulation of FiO2 with an integral ring vylife Boussignac starts with the chosen mode of ventilation and pressures Adjustable pressure with buttons + and - Pressure Support(PS)=IPAP-EPAP Capnograph connection via interface or manometer port 9

10 O 2 vylife kit with Vylife apparatus code With Oxygen Stopcock 2 vylife extension kits allowing vylife Boussignac to be connected to a source of O2 1 Oxygen stopcock AFNOR = BSI = vylife charger 1 vylife apparatus 1 Rapid instructions for use 1 Oxygen stopcock 1 Balloon for test DIN = NORDIC = Without Oxygen stopcock 2 vylife extension kits allowing vylife Boussignac to be connected to a source of O2 1 vylife charger 1 vylife apparatus 1 Rapid instructions for use 1 Balloon for test Code With harness Without harness Oxygen extension tube Corrugated tube CPAP Boussignac FiO2 ring Trigger Face mask Oxygen extension tube Corrugated tube CPAP Boussignac FiO2 ring Trigger Facial mask Single use sets Code Mask size

11 vylife Boussignac References (1) Willem Dieperink, Iwan Van der Horst, et al. Boussignac continuous positive airway pressure for the management of acute cardiogenic pulmonary edema. BMC Cardiovascular Disorders 2007, 7: 40. (2) Dottorini M, et al. Nasal-continuous positive airway pressure in the treatment of near-drowning in fresh-water. Chest ; 110 : (3) Laurent Brochard, Bernard Maitre, et al. Aerosol delivery with the Boussignac CPAP device. Respiratory Care. Oct (4) Service d Aide Médicale d Urgence (SAMU) de Lille: Protocole d utilisation de la CPAP de Boussignac avec nébuliseur. 14 mars (5) Wong D., et al. A comparison between the Boussignac continuous positive airway pressure mask and the venturi mask in terms of improvement in the Pa02/ FiO2 ratio in morbidly obese patients undergoing bariatric surgery Can J Anesth. 58 (6) : (6) Delay J.M., Jaber S. Respiratory preparation before surgery in patients with chronic respiratory failure. Presse médicale : (7) Neligan P., et al. Continuous positive airway pressure via the Boussignac system immediately after extubation improves lung function in morbidly obese patients with obstructive sleep apnea undergoing laparoscopic bariatric surgery Anesthesiology 110 (4) : (8) Dieperink W, et al. Boussignac continuous positive airway pressure for weaning with tracheostomy tubes Respiration 75 (4) : (9) Maitre b, jaber s, Maggiore s.m, bergot e, richard j.c, Bakthiari h, housset b, Boussignac g, brochard l, Unité de Pneumologie, Service de Soins Intensifs et Unité INSERM U 492, Hôpital H. Mondor, AP-HP, Université Paris 12 - Créteil (94) France - Continuous Positive Airway Pressure during Fiberoptic Bronchoscopy in Hypoxemic Patients - Am J Resp Crit Care Med Vol.162. pp , (10) Fleming P.F., et al. Use of continuous positive airway pressure during stabilisation and infants with suspected bronchiolitis J Paediatr Child Health. (11) Brochard L., et al. Evaluation d un nouvel appareil de ventilation assistée portable : La Vylife de Boussignac. SRLF «Performances of Vylife Boussignac are similar to current resuscitation ventilators». (12) Meduri Gu and al. Noninvasive positive pressure ventilation via face mask. First-line intervention in patients with acute hypercapnic and hypoxemic respiratory failure. Chest 1996 Jan;109(1): (13) Ram FS and al. Non-invasive positive pressure ventilation for treatment of respiratory failure due to exacerbations of chronic obstructive pulmonary disease. Cochrane DatabaseSyst Rev. 2004;(3):CD (14) Templier F., et al. Boussignac continuous positive airway pressure system: practical use in a prehospital medical care unit Eur J Emerg Med 10(2): (15) Lyazidi A and al. Evaluation des systèmes à Pression Positive Continue (CPAP) sur banc d essai. Hôpitaux Universitaires de Genève. (16) Valero P., Khoury a., et al. Comparison between 3 devices delivering continuous Positive Airway Pressure (CPAP). Poster. SRLF (17) Jaber S., et al. Un nouveau ventilateur «léger», la Vylife : Evaluation sur banc. SFAR (18) Serrano Simon, et al. Response characteristics of portable ventilation system : Boussignac Vylife. ESICM 2012 «Pressurization, trigger delay and adaptation is appropriate to each patient». (19) Richard JC, Cordioli RL, Brochard L, et al. Testing the Boussignac CPAP system on an active bench model simulating spontaneous ventilation and comparing its efficacy and resistive properties to other CPAP systems. Laboratory University Hospital, Geneva. (20) Marvin Wayne. CPAP in asthma & COPD. JEMS January (21) Laurent Brochard, Bernard Maitre, et al. Aerosol delivery with the Boussignac CPAP device. Respiratory Care. Oct (22) Davies LK, et al. Continuous positive airway pressure is beneficial in treatment of smoke inhalation. Crit Care Med ; 11 : (23) Gazynski T., et al. Boussignac CPAP in the post operative period in morbidity obese patients Obes Surg. 17 (4):

12 ANAESTHESIA EMERGENCY For further information, please contact: The specifications shown in this leaflet are for information only and are not, under any circumstances, of a contractual nature. 10/17 - DB RESP E Vygon 5, rue Adeline ECOUEN FRANCE Reception: +33 (0) Service clients France: +33 (0) Export customer service: +33 (0) Fax.: +33 (0)