VENTILATION SERVO-i WITH NAVA

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1 VENTILATION SERVO-i WITH NAVA FREEING the full potential of synchrony This document is intended to provide information to an international audience outside of the US.

2 2 SERVO-i with NAVA Critical Care SERVO-i WITH NAVA patient and ventilator as one NAVA : Neurally Adjusted Ventilatory Assist (NAVA) is a unique approach to mechanical ventilation based on neural respiratory output, in connection with invasive and non-invasive NAVA. 1 5 The act of taking a breath is controlled by the respiratory center of the brain, which decides the characteristics of each breath, timing and size. The respiratory center sends a signal along the phrenic nerve, excites the diaphragm muscle cells, leading to muscle contraction and descent of the diaphragm dome. As a result, the pressure in the airway drops, causing an inflow of air into the lungs. 2 With NAVA, the electrical activity of the diaphragm (Edi) is captured, fed to the ventilator and used to assist the patient s breathing in synchrony with and in proportion to the patients own efforts, regardless of patient category or size. As the work of the ventilator and the diaphragm is controlled by the same signal, coupling between the diaphragm and the SERVO-i ventilator is synchronized simultaneously. 4 3 Synchrony in invasive NAVA.

3 Critical Care SERVO-i with NAVA 3 NAVA and the breathing process 1 The brain's respiratory center sends a signal 2 which travels via the phrenic nerve and 3 excites the diaphragm. 4 The Edi catheter with the electrodes positioned at the level of the diaphragm captures the electrical activity of the diaphragm (Edi). 5 The Edi signal is sent to the SERVO-i ventilator which synchronizes the ventilation in proportion to the patient's own breathing efforts. NIV NAVA : In conventional non-invasive ventilation (NIV) patient-ventilator asynchrony is common. Scientific studies suggest that leaks play a major role in generating patientventilator asynchrony and discomfort. In infants and neonates, conventional NIV may be complicated by leakage and also because the effort by the infant has been too weak to be reliably detected by the ventilator s pressure and flow triggers. NIV NAVA is neurally controlled non-invasive ventilation. NIV NAVA will provide synchronized assist, independent of conventional pneumatic sensors and leakage associated with patient interfaces. NIV NAVA manages asynchrony, as the mode does not rely on a pneumatic signal and is not affected by auto PEEP. Breath triggering and cycle off are not affected by leakage, and every patient effort independent of type of interface is assessed and responded to equally effectively for all patients from adult to the smallest neonates. Synchrony in NIV NAVA.

4 4 SERVO-i with NAVA Critical Care SERVO-i WITH NAVA The benefits Synchrony redefined: In NAVA, the ventilator delivers assist in proportion to patient demand, and the patient and ventilator are always in synchrony. This benefits the patient, as the synchronized respiratory assist enables lower assist levels, and eliminates the mismatch in pneumatic timing of inspiration and expiration, avoiding the risk of missed efforts. NAVA provides a smooth transition to natural breathing. Decision support for unloading and assist titration: The Edi signal enables the clinicians to set the assist level from the ventilator, and to optimize unloading. PEEP titrated to the lowest Edi amplitude means that work of breathing is mini mized. As the patient s condition improves with NAVA, Edi amplitude decreases, resulting in a reduction in ventilator-delivered pressure. Edi the respiratory vital sign: The Edi signal is a unique parameter in mechanical ventilation. It can be used as a diagnostic tool to monitor the electrical activity of the diaphragm (Edi) in any situation for your patients with breathing difficulties, in any ventilation mode as well as in standby after extubation. In all ventilation modes, the Edi curve and its associated value can provide information on respiratory drive, volume requirements and the effect of the ventilatory settings, and can be used to gain indications for sedation and weaning, as well as continuous insight into the patient diaphragmatic status. All the trends and changes in the patient s respiratory drive are recorded and saved. Decision support for intubation or extubation: The Edi signal also indicates patient condition. An increasing Edi may signify increasing weakness or worsening of the patient condition, as objective criteria for intubation decisions. As the patient s condition improves, the decreasing Edi amplitude and pressure drop is an indicator to consider weaning and extubation. Synchrony redefined delivered assistance matched to neural demands Edi the respiratory vital sign Decision support for; unloading and assist titration intubation or extubation

5 Critical Care SERVO-i with NAVA 5 SERVO-i WITH NAVA Redefining what s possible Patient comfort: With NAVA, the respiratory muscles and the ventilator are driven by the same signal. The delivered assistance is matched to neural demands. This synchrony between patient and ventilator may minimize patient discomfort and agitation, promoting spontaneous breathing, providing for improved sleep quality and possibly reducing sedation. Decreasing the patient s pressure load and risk of overassist: With NAVA, the patient s own respiratory demands determine the level of assistance. The use of NAVA helps avoid over- or under-assistance of the patient. In an increasing number of clinical studies, NAVA has been associated with lower peak airway pressures, compared to conventional mechanical ventilation with Pressure Support. In neonatal and pediatric intensive care patient populations, ventilation with NAVA was associated with improved patient-ventilator synchrony and lower peak airway pressure when compared with Pressure Support ventilation. In addition to limiting the risk of overassist, NAVA has been found to prevent patient-ventilator asynchrony and improve overall patient-ventilator interaction in adult intensive care patients. NAVA was also associated with unloading of the respiratory muscles. Improved patient comfort Decreasing the patient s pressure load and risk of overassist Smooth transition to natural breathing

6 6 SERVO-i with NAVA Critical Care SERVO-i FREEING the full po NAVA independent of type of interface. Every patient effort is assessed and responded to equally effectively for all patients from adult to the smallest neonates.

7 WITH NAVA tential of synchrony Critical Care SERVO-i with NAVA 7

8 CCnews18_ indd SERVO-i with NAVA Critical Care SERVO-i WITH NAVA an established treatment worldwide VA RIENCES NAVA is used in intensive care units in countries all around the world for neonatal, pediatric and adult patients. Clinical evidence for NAVA has been documented in multiple clinical studies in scientific peer-reviewed journals, a body of work that continues to grow exponentially every year. Peer-to-peer forum for sharing NAVA experience The magazine Critical Care News and its associated website, is a forum hosted by MAQUET Critical Care for intensive care clinicians to share clinical experience of NAVA. The website is a primary source of user information about NAVA and NIV NAVA, and contains up-to-date lists of clinical literature reference lists, patient case reports about the use of NAVA in neonatal, pediatric and adult patients, as well as numerous NAVA lectures and interviews with intensive care physicians about NAVA. No. 18 Critical Care News Critical Care News Cindy Zimmel, RN and neonatologist Howard Stein, MD with NAVA neonatal patient Clinical experience of NAVA in 40 neonatal patients Toledo Children s Hospital in Toledo, Ohio cared for over 4,400 patients in 2007 and is accredited by The Joint Commission. The institution hosts the largest Level III newborn intensive care unit (NICU) in the region, with 60 beds in individual units to accommodate the needs of the infant and parents, with over 700 admissions per year. The newborn intensive care unit implemented Neurally Adjusted Ventilatory Assist NAVA earlier this year, and staff members have been gaining experience with NAVA in neonatal patients and newborns with a variety of different conditions. Critical Care News spoke with Judith Gresky, RN, MSN, CMP, NICU Director, Diane Howard, RRT, Educational Coordinator and neonatologist Howard Stein, MD regarding their experience in implementing NAVA and Edi technology and using it on a regular basis. CCnews18_ indd Diane Howard, RRT, NPS, Education Coordinator for Respiratory Therapy at Toledo Children s Hospital Theme: Deepening knowledge and experience of new ventilation therapies PAGE 2 Can you describe the size of your NICU department, average number of patients and staff? Judith Gresky: We have 60 beds, and 100 nurses on staff as well as 50 extra staff members. We have admissions per year or about 60 per month, with an average census of about 46 per week. We have a labor and delivery room here, and a transport team that provides transport to 35-39% of our patients in a 27 county area in the northwest corner of Ohio and southeast corner of Michigan. The average length of stay for our patients is about days. Gestational ages range from about weeks at the earliest, to full term, and we have 8 neonatologists on staff to provide around the clock care. Dr Howard Stein: This NICU unit has been in operation for 32 years, and Dr Krishnan, our senior partner, started the unit. We have 8 neonatologists and we provide in-hospital coverage 24 hours a day. There are also 4 neonatal nurse practitioners and residents from pediatrics and family practice programs Neonatal and Pediatric Ventilation: Emerging Trends and Challenges A Symposium Summary Report from Akron Children s Hospital PAGE 16 Clinical experience of NAVA in 40 neonatal patients Neonatologist Howard Stein MD, Diane Howard, RRT, Educational Coordinator and Judith Gresky, RN, NICU Director, Toledo Children s Hospital PAGE 22 Judith Gresky, RN, MSN, CMP and NICU Director at Toledo Children s Hospital. Research and establishing standards of care and training for neonatal intensive care in China Dr Bo Sun, MD, PhD, Head of Laboratory of Pediatric Respiratory and Intensive Care Medicine at Shanghai Children s Hospital of Fudan University, China PAGE 32 who work with us. Our facilities and the services we provide have developed and expanded throughout the years. In our latest facility, which we completed 1 year ago, we quadrupled our space for babies and families. Most of our babies now have private rooms and we also have some twin rooms. First impressions of the use of a new Heliox ventilator solution Intensive care physician Dr Ian White of the ICU of St. Peter s Hospital, Surrey, United Kingdom PAGE 36 The need for high ventilatory performance in anesthesia perspectives from two clinicians in anesthesiology Professor Capdevila, The University Hospital (CHU) of Montpellier, France and Professor Lönnqvist, pediatric anesthesiologist at Astrid Lindgren Children s Hospital at Karolinska University Hospital, Stockholm, Sweden PAGE 40 Which types or modes of ventilation are traditionally used in the NICU? Diane Howard: Prior to implementing our SERVO-i ventilators in the fall of 2007, we had been ventilating our babies with the VIP Bird. While this ventilator was state of the art when introduced several years ago, it lacked the newer modes of ventilation, such as Pressure Regulated Volume Control (PRVC) and BiVent. We have used several of these different modes of ventilation on our babies but Synchronized Intermittent Mandatory Ventilation (SIMV) with Pressure Control has been most frequently used. We have used PRVC but have found it difficult due to air leaks around the endotracheal tubes. Volume Control is utilized mostly on our post-surgical gastrointestinal babies, as their bellies become distended and put pressure on the diaphragm. BiVent mode works well but is not as user friendly as SIMV Pressure Control. Since we have 8 neonatologists in our NICU, the most common mode of ventilation is SIMV(PC). Dr Howard Stein: We have traditionally used pressure limited ventilation with SIMV. There is an occasional patient that needs volume limited ventilation. We have tried PRVC but this was not successful due to the large airleaks associated with using uncuffed endotracheal tubes. About a year ago we introduced Bivent but this has been put on hold as we have learned to use NAVA. Can you describe the weaning process you utilize currently, for example with SIMV and how you determine appropriate time for extubation? Diane Howard: Our usual approach to weaning ventilator parameters is to initially decrease the pressures per blood gas and chest x-ray results because barotrauma is a contributor to chronic lung disease (CLD). We wean to minimal pressures without creating atelectasis and then decrease the rate. If the baby does not have an increase in work of breathing and does not have apneic spells, the endotracheal tube is removed. Occasionally, a trial of endotracheal CPAP is ordered and if successful, the baby is extubated. We do not sedate our babies significantly in our NICU. What generally is your extubation success rate? What is the reintubation rate within 48 hours? Diane Howard: Our re-intubation rate within hours after extubation is generally low, but with neonates anytime they acquire an infection or become more apneic, they can find themselves back on the ventilator within a week or two. They are not really considered extubation failures, but have become sick again and need ventilatory support. In our older babies, the rate is low, while in week range, 50-70% are intubated more than once, fairly typical for this gestational age. CCnews18_ indd PAGE 4 Institutional experience of NAVA in neuro and cardiovascular intensive care patients Jim Kutsogiannis, MD, Darryl Ewanchuk, RRT, Craig Guenther, MD, Kevin Coghlan, RRT and Julie Mitchell, RRT, of the University of Alberta Hospital in Edmonton, Canada

9 Critical Care SERVO-i with NAVA 9 REFERENCES Selected publications on the topic of NAVA and NIV. 1. Campoccia Jalde F, Almadhoob AT, Beck J, Slutsky AS, Dunn MS, Sinderby C. Neurally adjusted ventilatory assist and pressure support ventilation in small species and the impact of instrumental dead space. Neonatology 2009; 97 (3): Brander L, Sinderby C, Lecomte F, Leong-Poi H, Bell D, Beck J, Tsoporis JN, Vaschetto R, Schultz MJ, Parker TG, Villar J, Zhang H, Slutsky AS. Neurally adjusted ventilatory assist decreases ventilator-induced lung injury and non-pulmonary organ dysfunction in rabbits with acute lung injury. Intensive Care Med 2009; 16: DOI /s z. 3. Sinderby C, Beck J. Neurally adjusted ventilatory assist for infants in critical condition: Editorial. Pediatric Health (2009); 3(4): Breatnach C, Conlon NP, Stack M, Healy M, O Hare BP. A prospective crossover comparison of neurally adjusted ventilatory assist and pressuresupport ventilation in a pediatric and neonatal intensive care population. Pediatr Crit Care Med 2009; Jul 9. PMID Bengtsson JA, Edberg KE. Neurally adjusted ventilatory assist in children: An observational study. Pediatr Crit Care Med 2009; Jul 9. PMID Lecomte F, Brander L, Jalde F, Beck J, Qui H, Elie C, Slutsky AS, Brunet F, Sinderby C. Physiological response to increasing levels of neurally adjusted ventilatory assist (NAVA). Respir Physiol Neurobiol 2009; 166(2): Hummler H, Schultze A. New and alternative modes of mechanical ventilation in neonates. Semin Fetal Neonatal Med 2009; 14(1): Beck J, Reilly M, Grasselli G, Mirabella L, Slutsky AS, Dunn MS, Sinderby C. Patient-ventilator interaction during Neurally Adjusted Ventilatory Assist in Very Low Birth Weight Infants. Pediatr Res 2009; 65(6): Brander L, Leong-Poi H, Beck J, Brunet F, Hutchinson SJ, Slutsky AS, Sinderby C. Titration and implementation of neurally adjusted ventilatory assist in critically ill patients. Chest 2009; 35(3): Epub 2008 Nov Colombo D, Cammarota G, Bergamaschi V, De Luca M, Della Corte F, Navalesi P. Physiologic response to varying levels of pressure support and neurally adjusted ventilatory assist in patients with acute respiratory failure. Intensive Care Med 2008; 34(11): Epub 2008 Jul Laghi F. NAVA: Brain over machine? Intensive Care Med 2008; 34(11): Epub 2008 Jul Moerer O, Beck J, Brander L, Costa R, Quintel M, Slutsky AS, Brunet F, Sinderby C. Subject-ventilator synchrony during neural versus pneumatically triggered non-invasive helmet ventilation. Intensive Care Med 2008; 34(9): Epub 2008 May Vargas F. Neural trigger and cycling off during helmet pressure support ventilation: the epitome of the perfect patient ventilator interaction? Intensive Care Med 2008; 34(9): Epub 2008 May Sinderby C, Beck J. Neurally Adjusted Ventilatory Assist (NAVA): An Update and Summary of Experiences. Neth J Crit Care 2007; 11(5): Beck J, Brander L, Slutsky AS, Reilly MC, Dunn MS, Sinderby C. Noninvasive neurally adjusted ventilatory assist in rabbits with acute lung injury. Intensive Care Med 2008; 34(2): Epub 2007 Oct Sinderby C, Navalesi P, Beck J, Skrobik Y, Comtois N, Friberg S, Gottfried SB, Lindstrom L. Neural control of mechanical ventilation in respiratory failure. Nat Med 1999; 5(12): For more comprehensive lists of scientific studies on the topics of NAVA and NIV, please refer to and select topic under Reference List.

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11 The Gold Standard Critical Care SERVO-i with NAVA 11 SERVO-i WITH NAVA EMPOWERING HUMAN EFFORT MAQUET THE GOLD STANDARD In healthcare, it is a well known fact that the best interventions are those that interfere least with nature s own mechanisms. The MAQUET philosophy is that technical innovation must promote and support the body s natural functions. The MAQUET mission is to provide clinicians with tools to amplify the patient s own recovery efforts. SERVO-i is a platform that has been extended with an interactive ventilation therapy NAVA. A unique breakthrough in ventilation, NAVA puts the patient s respiratory center in direct control of SERVO-i mechanical support, breath by breath. MAQUET The Gold Standard.

12 Maquet Critical Care AB Solna, Sweden Phone: Please visit our websites This document is intended to provide information to an international audience outside of the US. The product NIV NAVA may be pending regulatory approvals to be marketed in your country. Contact your local Maquet representative for more information. The following are registered or pending trademarks of Maquet Critical Care AB: SERVO-i and NAVA GETINGE GROUP is a leading global provider of products and systems that contribute to quality enhancement and cost efficiency within healthcare and life sciences. We operate under the three brands of ArjoHuntleigh, GETINGE and MAQUET. ArjoHuntleigh focuses on patient mobility and wound management solutions. GETINGE provides solutions for infection control within healthcare and contamination prevention within life sciences. MAQUET specializes in solutions, therapies and products for surgical interventions and intensive care. Maquet Critical Care AB All rights reserved. MAQUET reserves the right to modify the design and specifications contained herein without prior notice. Order No. MX-0616 Printed in Sweden Rev.01 English.