An early warning indicator of tissue hypoxia.

Transcription

1 An early warning indicator of tissue hypoxia. Continuous ScvO2 monitoring with the PreSep oximetry catheter

2 Are your vital signs telling you everything? Valuable time may be lost before traditional vital signs or intermittent samplings indicate tissue hypoxia potentially delaying intervention and putting the patient at greater risk. Continuously monitoring central venous oxygen saturation ( ), through the PreSep oximetry catheter, enables the early detection and management of tissue hypoxia. 1-5 ECG MAP CVP = Early Warning and Prevention Hemodynamic Trends PreSep Oligon oximetry catheter with integrated antimicrobial protection SpO Hour 1.5 Hours 3 Hours Guides therapy and enables early intervention Continuous is a more sensitive indicator of tissue perfusion compared to intermittent sampling and traditional vital signs alone 1-5 Continuous monitoring reveals the true adequacy of tissue oxygenation, enabling early detection and assessment of clinical response to intervention 1,2 Continuous highly correlates and trends with 1,2 SvO 2 while providing the same utility in monitoring, which is essential in defining the adequacy of cardiac output 7 Convenient, accurate and easy-to-use The first proven triple lumen catheter with continuous monitoring Accurate versus CO-oximeter 6 Simple to use uses same insertion techniques as that of a central line Designed for use with Edwards oximetry monitors and optical cables

3 monitoring of at-risk patients. The prognostic value of 2 has been demonstrated in post-op high-risk surgeries, 9 trauma, 4 sepsis, 8,10 cardiac failure in CHF 5,10 and recovery in cardiac arrest. 11,12 High-risk surgery Reductions in are common after major surgery and are independently associated with post-operative complications. 9 monitoring in high-risk surgery has multiple applications in the intra- and post-op stages, including: Risk for high blood loss, such as hepatic resections, trauma, vascular cases High fluid shifts in gastrointestinal cases Toleration of single-lung ventilation in thoracic procedures Early treatment directed to maintain extraction ratio at < 27% reduces organ failures and hospital stay of high-risk surgical patients. 15 Intensive care An reading of less than 60% on unplanned admission to the ICU was associated with high mortality rates. 14 Types of ICU patients affected include those with: Heart failure Complex respiratory disease Coagulopathies Burns Trauma Sepsis Up to 50% of critically ill patients resuscitated from shock may have continued global tissue hypoxia despite the normalization of vital signs and CVP 2 Up to 39% of trauma patients have tissue hypoxia ( < 65%) despite stable vital signs 4 PreSep oximetry catheter

4 Sepsis Evidence-based protocols, such as Early Goal-Directed Therapy (EGDT), have been shown to be effective at improving patient costs and outcomes, including significant reductions in sepsis-related mortality. EGDT with the PreSep oximetry catheter has been shown to: Reduce in-hospital mortality by 34% in adult patients with severe sepsis and septic shock when used with Early Goal-Directed Therapy 2,8 Reduce in-hospital length-of-stay by 3.8 days 2,8 Reduce hospital charges by $12,000 Screen Early for At-Risk Patients 2 Signs of the Systemic Inflammatory Response Syndrome (SIRS) 8 Temp C < 36 C or 38 C l HR > 90 beats/min Resp > 20 breaths / min or PaCO 2 < 32 mm Hg WBC > 12,000/mm 3 or < 4,000/mm 3 or >10% immature bands Sign of Global Tissue Hypoxia Systolic BP 90 mm Hg or Lactate 4 mmol/l Early Goal-Directed Therapy Treatment Protocol 17 Supplemental oxygen ± endotracheal intubation and mechanical ventilation Central venous oximetry catheter and continuous arterial pressure monitoring Sedation, paralysis (if intubated), or both CVP MAP Central Venous Pressure Mean Arterial Pressure Central Venous Oxygen Saturation CVP < 8 mm Hg Crystalloid Colloid 8-12 mm Hg MAP < 65 mm Hg l > 90 mm Hg Vasoactive Agents 65 mm Hg l 90 mm Hg < 70% Transfusion of red cells until hematocrit 30% 70% Inotrope Agents 70% < 70% NO Goals Achieved YES Hospital Admission Septic patients are still not being adequately resuscitated early enough in the course of illness targeting this resuscitation to clearly defined and easily measurable end-points is the most appropriate course of action. 16

5 Balance of oxygen delivery and consumption for high-risk surgical, intensive care and sepsis patients. In the critically ill, traditional vital signs may be late indicators of compromised or inadequate oxygen delivery to the tissues. Continuous monitoring is key to assessing the adequacy of the balance of oxygen delivery and consumption. The goal of continuous monitoring with the PreSep oximetry catheter is to bring into balance the relationship between oxygen consumption and oxygen delivery to improve the care of high-acuity patients. 13 Oxygen Delivery Oxygen Consumption Cardiac Output Hemoglobin Oxygenation Metabolic Demand Heart Rate Stroke Volume Bleeding Hemodilution Anemia SaO 2 FiO 2 Ventilation Fever Anxiety Pain Shivering Muscle Activity Optimal HR Preload Afterload Contractility Bleeding Fluid Shifts Vascular Resistance Heart Disease For over 30 years, Edwards Lifesciences has been helping critical care clinicians worldwide. From developing the gold standard Swan-Ganz catheter, to offering the first continuous central venous oximetry catheter, Edwards continues its heritage as a global leader in hemodynamic monitoring and patient insight. Visit or call us at for more information.

6 Presep oximetry catheter ** specifications Model Description Oligon Antimicrobial Material Continuous Lumens Length cm Size F (mm) Lumen Size Gauge (mm) Distal Proximal Medial Recommended Dilator F (mm) Minimum Guidewire Size inch (mm) PreSep oximetry catheter Yes 3 16,* (2.83) 15 (1.77) 10.5 (3.5) (0.8) PreSep Oligon oximetry catheter Yes Yes 3 16,* (2.83) 15 (1.77) 10.5 (3.5) (0.8) *16cm length available in the U.S. only. **PreSep catheters are designed for use with Edwards Lifesciences oximetry monitors and OM2 Optics Modules to continuously monitor. PreSep catheters are available with AMC Thromboshield, an antibacterial heparin coating that decreases viable microbe count on the surface of product during handling and placement. PreSep Oligon oximetry catheters contain an integrated Oligon antimicrobial material. The activity of the antimicrobial material is localized at the catheter surfaces and is not intended for treatment of systemic infections. In vitro testing demonstrated that the Oligon material provided broad-spectrum effectiveness ( 3 log reduction from initial concentration within 48 hours) against the organisms tested: Staphylococcus aureus, Staphylococcus epidermidis, Klebsiella pneumoniae, Enterococcus faecalis, Candida albicans, Escherichia coli, Serratia marcescens, Acinetobacter calcoaceticus, Corynebacterium diphtheriae, Enterobacter aerogenes, GMRSa, Pseudomonas aeruginosa, Candida glabrata and VRE (Enterococcus faecium). Vigileo monitor product specifications Color Display 5.2 in. (132.5 mm) x 3.9 in. (99.4 mm) TFT l 640 x 480 pixels Power/Electrical AC Mains: VAC, 50/60 Hz l 1A maximum consumption Trend Range hours Size H: 7.3 in. (5.4 mm) l W: 10.7 in. (271.8 mm) l D: 8.4 in. (213.4 mm) Weight 6 pounds (2.73 kg) l IV pole-mount capability Bi-directional Patient Monitor Communications Printer Communications Medial Analog input/output (selectable voltage) Input: 0 to 1V, 0 to 5V, 0 to 10V l Output: 0 to 1V, 0 to 10V Digital input/output, serial communication interface (RS232) Maximum data rate 57.6 kilobaud USB Port: V1.1-compatible type A connector References: Reinhart, K, et al. Continuous central venous and pulmonary artery oxygen saturation monitoring in the critically ill. Intensive Care Med 2004;30(8): Rivers, EP, et al. Central venous oxygen saturation monitoring in the critically ill patient. Curr Opin Crit Care 2001;7(3): Ingelmo, P, et al. Importance of monitoring in high risk surgical patients. Minerva Anestesiol 2002;68(4): Scalea, TM, et al. Central venous oxygen saturation: a useful clinical tool in trauma patients. J Trauma 1990;30(12): Ander, DS, et al. Undetected cardiogenic shock in patients with congestive heart failure presenting to the emergency department. Am J Cardiol 1998;82(7): Edwards, Vigileo Operators Manual: A-4. Pinsky, MR, et al. Let us use the pulmonary artery catheter correctly and only when we need it. Crit Care Med 2005;33(5): Rivers, E, et al. Early goal-directed therapy in the treatment of severe sepsis and septic shock. N Engl J Med 2001;345(19): Pearse, R, et al. Changes in central venous saturation after major surgery, and association with outcome. Crit Care 2005;9(6):R Rady, MY, et al. Resuscitation of the critically ill in the ED: responses of blood pressure, heart rate, shock index, central venous oxygen saturation, and lactate. Am J Emerg Med 1996;14(2):2-25. Nakazawa, K, et al. Usefulness of central venous oxygen saturation monitoring during cardiopulmonary resuscitation. A comparative case study with end-tidal carbon dioxide monitoring. Intensive Care Med 1994;20(6): Rivers, EP, et al. The clinical implications of continuous central venous oxygen saturation during human CPR. Ann Emerg Med 1992;21(9): Loren, D. Continuous Venous Oximetry in Surgical Patients. Ann Surg 1986;203/3: Bracht, H, et al. Incidence of low central venous oxygen saturation during unplanned admissions in a multidisciplinary intensive care unit: an observational study. Crit Care 2007; 11:R2. Donati, A, et al. Goal-directed intraoperative therapy reduces morbidity and length of hospital stay in high-risk surgical patients. Chest 2007,132: Bennet, D. Early resuscitation in the emergency room: dramatic effects that we should not ignore. Critical Care 2002; 6:7-8. Adapted with permission from Rivers et al. Early Goal-Directed Therapy in the Treatment of Severe Sepsis and Septic Shock. New England Journal of Medicine 2001; 345(19): , Figure 2. Strategic tools for streamlining care and improving clinical effectiveness. COR Clinical Excellence 2002; 3(1):1-5. Dr. Emanuel Rivers is a paid consultant of Edwards Lifesciences. Rx only. See instructions for use for full prescribing information. Edwards Lifesciences devices placed on the European market meeting the essential requirements referred to in Article 3 of the Medical Device Directive 93/42/EEC bear the CE marking of conformity. Edwards is a trademark of Edwards Lifesciences Corporation. Edwards Lifesciences, the stylized E logo, AMC Thromboshield, PreSep, Swan-Ganz and Vigileo are trademarks of Edwards Lifesciences Corporation and are registered in the United States Patent and Trademark Office. Oligon is a trademark of Implemed, Inc. Early Goal-Directed Therapy and EGDT are trademarks of Dr. Emanuel Rivers Edwards Lifesciences LLC. All rights reserved. AR03768 Visit or call us at for more information. Edwards Lifesciences LLC One Edwards Way Irvine, CA USA Edwards Lifesciences (Canada) Inc Central Pkwy West, Suite 300 Mississauga, Ontario Canada L5C 4R Edwards Lifesciences Europe Ch. du Glapin Saint-Prex Switzerland Edwards Lifesciences Japan 2-8 Rokubancho Chiyoda-ku, Tokyo Japan