Post on 25-Jul-2020
transcript
An early warning indicator of tissue hypoxia.
Continuous ScvO2 monitoring with the PreSep oximetry catheter
Edwards Lifesciences LLC · One Edwards Way · Irvine, CA 92614 USA · 949.250.2500 · 800.424.3278 · www.edwards.com Edwards Lifesciences (Canada) Inc. · 1290 Central Pkwy West, Suite 300 · Mississauga, Ontario · Canada L5C 4R3 · 905.566.4220 · 800.268.3993
Edwards Lifesciences Europe · Ch. du Glapin 6 · 1162 Saint-Prex · Switzerland · 41.21.823.4300 Edwards Lifesciences Japan · 2-8 Rokubancho · Chiyoda-ku, Tokyo 102-0085 · Japan · 81.3.5213.5700
Vigileo monitor product specificationsColor Display
Power/Electrical
Trend Range
Size
Weight
PrinterCommunications
Medial
Bi-directionalPatient MonitorCommunications
5.2 in. (132.5 mm) x 3.9 in. (99.4 mm) TFT l 640 x 480 pixels
0.1 – 72 hours
6 pounds (2.73 kg) l IV pole-mount capability
Maximum data rate — 57.6 kilobaud
Analog input/output (selectable voltage)
Digital input/output, serial communication interface (RS232)
AC Mains: 100-240 VAC, 50/60 Hz l 1A maximum consumption
H: 7.3 in. (185.4 mm) l W: 10.7 in. (271.8 mm) l D: 8.4 in. (213.4 mm)
Input: 0 to 1V, 0 to 5V, 0 to 10V l Output: 0 to 1V, 0 to 10V
USB Port: V1.1-compatible type A connector
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.
©2008 Edwards Lifesciences LLC. All rights reserved. AR03768
Visit www.Edwards.com/PreSep or call us at 800.424.3278 for more information.
Reinhart, K, et al. Continuous central venous and pulmonary artery oxygen saturation monitoring in the critically ill. Intensive Care Med 2004;30(8):1572-8.Rivers, EP, et al. Central venous oxygen saturation monitoring in the critically ill patient. Curr Opin Crit Care 2001;7(3):204-11.Ingelmo, P, et al. Importance of monitoring in high risk surgical patients. Minerva Anestesiol 2002;68(4):226-30. Scalea, TM, et al. Central venous oxygen saturation: a useful clinical tool in trauma patients. J Trauma 1990;30(12):1539-43.Ander, DS, et al. Undetected cardiogenic shock in patients with congestive heart failure presenting to the emergency department. Am J Cardiol 1998;82(7):888-91.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):1119-22.Rivers, E, et al. Early goal-directed therapy in the treatment of severe sepsis and septic shock. N Engl J Med 2001;345(19):1368-77.Pearse, R, et al. Changes in central venous saturation after major surgery, and association with outcome. Crit Care 2005;9(6):R694-9.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):218-25.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):450-1.Rivers, EP, et al. The clinical implications of continuous central venous oxygen saturation during human CPR. Ann Emerg Med 1992;21(9):1094-101.Loren, D. Continuous Venous Oximetry in Surgical Patients. Ann Surg 1986;203/3:329-333.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 2007,132:1817-1824.
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): 1368-77, Figure 2.Strategic tools for streamlining care and improving clinical effectiveness. COR Clinical Excellence 2002; 3(1):1-5.
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References:
PreSepoximetrycatheter
PreSep Oligon†
oximetrycatheter
ModelDescription
Yes
OligonAntimicrobial
Material†
3
3
Lumens
16,* 20
16,* 20
Lengthcm
8.5 (2.83)
8.5 (2.83)
Size F(mm)
Yes
Yes
ContinuousScvO2
Lumen Size Gauge (mm)
0.032 (0.8)
0.032 (0.8)
MinimumGuidewire Size
inch (mm)
10.5(3.5)
10.5(3.5)
RecommendedDilator F (mm)
15(1.77)
15(1.77)
Distal
18(1.33)
18(1.33)
Proximal
18(1.33)
18(1.33)
Medial
*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 ScvO2. 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).
Presep oximetry catheter** specifications
Convenient, accurate and easy-to-use
• The first proven triple lumen catheter with continuous
ScvO2 monitoring
• Accurate versus CO-oximeter6
• Simple to use – uses same insertion techniques as
that of a central line
• Designed for use with Edwards oximetry monitors
and optical cables
Are your vital signs telling you everything?
PreSep oximetry catheter
•Upto50%ofcriticallyillpatients
resuscitated from shock may have
continued global tissue hypoxia
despite the normalization of vital
signs and CVP2
•Upto39%oftraumapatientshave
tissue hypoxia (ScvO2<65%)despite
stable vital signs4
High-risk surgery
Reductions in ScvO2 are common after major surgery and are independently associated with post-operative
complications.9 ScvO2 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
Earlytreatmentdirectedtomaintainextractionratioat<27%reduces organ failures and hospital stay of high-risk
surgical patients.15
• Heart failure
• Complex respiratory disease
• Coagulopathies
• Burns
• Trauma
• Sepsis
Intensive care
An ScvO2readingoflessthan60%onunplanned
admissiontotheICUwasassociatedwithhigh
mortality rates.14 TypesofICUpatientsaffected
include those with:
ScvO2 = Early Warning and Prevention
ECG
MAP
CVP
SpO2
ScvO2
Hemodynamic Trends150100509060301050
100
755025
ScvO2 monitoring of at-risk patients.The prognostic value of ScvO2
2 has been demonstrated in post-op high-risk surgeries,9 trauma,4 sepsis,8,10 cardiac
failure in CHF5,10 and recovery in cardiac arrest.11,12
Guides therapy and enables early intervention
• Continuous ScvO2 is a more sensitive indicator of
tissue perfusion compared to intermittent sampling
and traditional vital signs alone1-5
• Continuous ScvO2 monitoring reveals the true
adequacy of tissue oxygenation, enabling early detection
and assessment of clinical response to intervention1,2
• Continuous ScvO2 highly correlates and trends with
SvO21,2 while providing the same utility in monitoring,
which is essential in defining the adequacy of
cardiac output7
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:
• Reducein-hospitalmortalityby34%inadultpatientswithsevere sepsis and septic shock
when used with Early Goal-Directed Therapy2,8
• Reduce in-hospital length-of-stay by 3.8 days2,8
• Reduce hospital charges by $12,00018
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
Hospital Admission
Goals Achieved
YES
Transfusion of red cells until hematocrit ≥ 30%
< 70%
Inotrope Agents
≥ 70%ScvO2
2 Signs of the Systemic InflammatoryResponse Syndrome (SIRS)8
Temp C° < 36°C or ≥ 38°C l HR > 90 beats/minResp > 20 breaths / min or PaCO2 < 32 mm Hg
WBC > 12,000/mm3 or < 4,000/mm3or>10%immaturebands
Systolic BP ≤ 90 mm Hg or
Lactate ≥ 4 mmol/L
Sign of Global Tissue Hypoxia
Screen Early for At-Risk Patients
Vasoactive Agents< 65 mm Hg l > 90 mm HgMAP
Early Goal-Directed Therapy Treatment Protocol17
Crystalloid
Colloid< 8 mm HgCVP
Sedation, paralysis (if intubated), or both
NO
Central venous oximetry catheter andcontinuous arterial pressure monitoring
Supplemental oxygen ± endotracheal intubation and mechanical ventilation
CVPMAP
ScvO2
Central Venous PressureMean Arterial PressureCentral Venous Oxygen Saturation
8-12 mm Hg
≥ 65 mm Hg l ≤ 90 mm Hg
≥ 70% < 70%
Valuable time may be lost before traditional vital
signs or intermittent ScvO2 samplings indicate
tissue hypoxia – potentially delaying intervention
and putting the patient at greater risk.
Continuously monitoring central venous
oxygen saturation (ScvO2), through the PreSep
oximetry catheter, enables the early detection
and management of tissue hypoxia.1-5
PreSep Oligon oximetry catheter with integrated
antimicrobial protection†
0 Hour 1.5 Hours 3 Hours
Edwards Lifesciences LLC · One Edwards Way · Irvine, CA 92614 USA · 949.250.2500 · 800.424.3278 · www.edwards.com Edwards Lifesciences (Canada) Inc. · 1290 Central Pkwy West, Suite 300 · Mississauga, Ontario · Canada L5C 4R3 · 905.566.4220 · 800.268.3993
Edwards Lifesciences Europe · Ch. du Glapin 6 · 1162 Saint-Prex · Switzerland · 41.21.823.4300 Edwards Lifesciences Japan · 2-8 Rokubancho · Chiyoda-ku, Tokyo 102-0085 · Japan · 81.3.5213.5700
Vigileo monitor product specificationsColor Display
Power/Electrical
Trend Range
Size
Weight
PrinterCommunications
Medial
Bi-directionalPatient MonitorCommunications
5.2 in. (132.5 mm) x 3.9 in. (99.4 mm) TFT l 640 x 480 pixels
0.1 – 72 hours
6 pounds (2.73 kg) l IV pole-mount capability
Maximum data rate — 57.6 kilobaud
Analog input/output (selectable voltage)
Digital input/output, serial communication interface (RS232)
AC Mains: 100-240 VAC, 50/60 Hz l 1A maximum consumption
H: 7.3 in. (185.4 mm) l W: 10.7 in. (271.8 mm) l D: 8.4 in. (213.4 mm)
Input: 0 to 1V, 0 to 5V, 0 to 10V l Output: 0 to 1V, 0 to 10V
USB Port: V1.1-compatible type A connector
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.
©2008 Edwards Lifesciences LLC. All rights reserved. AR03768
Visit www.Edwards.com/PreSep or call us at 800.424.3278 for more information.
Reinhart, K, et al. Continuous central venous and pulmonary artery oxygen saturation monitoring in the critically ill. Intensive Care Med 2004;30(8):1572-8.Rivers, EP, et al. Central venous oxygen saturation monitoring in the critically ill patient. Curr Opin Crit Care 2001;7(3):204-11.Ingelmo, P, et al. Importance of monitoring in high risk surgical patients. Minerva Anestesiol 2002;68(4):226-30. Scalea, TM, et al. Central venous oxygen saturation: a useful clinical tool in trauma patients. J Trauma 1990;30(12):1539-43.Ander, DS, et al. Undetected cardiogenic shock in patients with congestive heart failure presenting to the emergency department. Am J Cardiol 1998;82(7):888-91.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):1119-22.Rivers, E, et al. Early goal-directed therapy in the treatment of severe sepsis and septic shock. N Engl J Med 2001;345(19):1368-77.Pearse, R, et al. Changes in central venous saturation after major surgery, and association with outcome. Crit Care 2005;9(6):R694-9.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):218-25.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):450-1.Rivers, EP, et al. The clinical implications of continuous central venous oxygen saturation during human CPR. Ann Emerg Med 1992;21(9):1094-101.Loren, D. Continuous Venous Oximetry in Surgical Patients. Ann Surg 1986;203/3:329-333.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 2007,132:1817-1824.
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): 1368-77, Figure 2.Strategic tools for streamlining care and improving clinical effectiveness. COR Clinical Excellence 2002; 3(1):1-5.
1.
2.
3.
4.
5.
6.7.
8.
9.
10.
11.
12.
13.14.
15.
16.
17.
18.
References:
PreSepoximetrycatheter
PreSep Oligon†
oximetrycatheter
ModelDescription
Yes
OligonAntimicrobial
Material†
3
3
Lumens
16,* 20
16,* 20
Lengthcm
8.5 (2.83)
8.5 (2.83)
Size F(mm)
Yes
Yes
ContinuousScvO2
Lumen Size Gauge (mm)
0.032 (0.8)
0.032 (0.8)
MinimumGuidewire Size
inch (mm)
10.5(3.5)
10.5(3.5)
RecommendedDilator F (mm)
15(1.77)
15(1.77)
Distal
18(1.33)
18(1.33)
Proximal
18(1.33)
18(1.33)
Medial
*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 ScvO2. 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).
Presep oximetry catheter** specifications
Convenient, accurate and easy-to-use
• The first proven triple lumen catheter with continuous
ScvO2 monitoring
• Accurate versus CO-oximeter6
• Simple to use – uses same insertion techniques as
that of a central line
• Designed for use with Edwards oximetry monitors
and optical cables
Are your vital signs telling you everything?
PreSep oximetry catheter
•Upto50%ofcriticallyillpatients
resuscitated from shock may have
continued global tissue hypoxia
despite the normalization of vital
signs and CVP2
•Upto39%oftraumapatientshave
tissue hypoxia (ScvO2<65%)despite
stable vital signs4
High-risk surgery
Reductions in ScvO2 are common after major surgery and are independently associated with post-operative
complications.9 ScvO2 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
Earlytreatmentdirectedtomaintainextractionratioat<27%reduces organ failures and hospital stay of high-risk
surgical patients.15
• Heart failure
• Complex respiratory disease
• Coagulopathies
• Burns
• Trauma
• Sepsis
Intensive care
An ScvO2readingoflessthan60%onunplanned
admissiontotheICUwasassociatedwithhigh
mortality rates.14 TypesofICUpatientsaffected
include those with:
ScvO2 = Early Warning and Prevention
ECG
MAP
CVP
SpO2
ScvO2
Hemodynamic Trends150100509060301050
100
755025
ScvO2 monitoring of at-risk patients.The prognostic value of ScvO2
2 has been demonstrated in post-op high-risk surgeries,9 trauma,4 sepsis,8,10 cardiac
failure in CHF5,10 and recovery in cardiac arrest.11,12
Guides therapy and enables early intervention
• Continuous ScvO2 is a more sensitive indicator of
tissue perfusion compared to intermittent sampling
and traditional vital signs alone1-5
• Continuous ScvO2 monitoring reveals the true
adequacy of tissue oxygenation, enabling early detection
and assessment of clinical response to intervention1,2
• Continuous ScvO2 highly correlates and trends with
SvO21,2 while providing the same utility in monitoring,
which is essential in defining the adequacy of
cardiac output7
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:
• Reducein-hospitalmortalityby34%inadultpatientswithsevere sepsis and septic shock
when used with Early Goal-Directed Therapy2,8
• Reduce in-hospital length-of-stay by 3.8 days2,8
• Reduce hospital charges by $12,00018
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
Hospital Admission
Goals Achieved
YES
Transfusion of red cells until hematocrit ≥ 30%
< 70%
Inotrope Agents
≥ 70%ScvO2
2 Signs of the Systemic InflammatoryResponse Syndrome (SIRS)8
Temp C° < 36°C or ≥ 38°C l HR > 90 beats/minResp > 20 breaths / min or PaCO2 < 32 mm Hg
WBC > 12,000/mm3 or < 4,000/mm3or>10%immaturebands
Systolic BP ≤ 90 mm Hg or
Lactate ≥ 4 mmol/L
Sign of Global Tissue Hypoxia
Screen Early for At-Risk Patients
Vasoactive Agents< 65 mm Hg l > 90 mm HgMAP
Early Goal-Directed Therapy Treatment Protocol17
Crystalloid
Colloid< 8 mm HgCVP
Sedation, paralysis (if intubated), or both
NO
Central venous oximetry catheter andcontinuous arterial pressure monitoring
Supplemental oxygen ± endotracheal intubation and mechanical ventilation
CVPMAP
ScvO2
Central Venous PressureMean Arterial PressureCentral Venous Oxygen Saturation
8-12 mm Hg
≥ 65 mm Hg l ≤ 90 mm Hg
≥ 70% < 70%
Valuable time may be lost before traditional vital
signs or intermittent ScvO2 samplings indicate
tissue hypoxia – potentially delaying intervention
and putting the patient at greater risk.
Continuously monitoring central venous
oxygen saturation (ScvO2), through the PreSep
oximetry catheter, enables the early detection
and management of tissue hypoxia.1-5
PreSep Oligon oximetry catheter with integrated
antimicrobial protection†
0 Hour 1.5 Hours 3 Hours
Edwards Lifesciences LLC · One Edwards Way · Irvine, CA 92614 USA · 949.250.2500 · 800.424.3278 · www.edwards.com Edwards Lifesciences (Canada) Inc. · 1290 Central Pkwy West, Suite 300 · Mississauga, Ontario · Canada L5C 4R3 · 905.566.4220 · 800.268.3993
Edwards Lifesciences Europe · Ch. du Glapin 6 · 1162 Saint-Prex · Switzerland · 41.21.823.4300 Edwards Lifesciences Japan · 2-8 Rokubancho · Chiyoda-ku, Tokyo 102-0085 · Japan · 81.3.5213.5700
Vigileo monitor product specificationsColor Display
Power/Electrical
Trend Range
Size
Weight
PrinterCommunications
Medial
Bi-directionalPatient MonitorCommunications
5.2 in. (132.5 mm) x 3.9 in. (99.4 mm) TFT l 640 x 480 pixels
0.1 – 72 hours
6 pounds (2.73 kg) l IV pole-mount capability
Maximum data rate — 57.6 kilobaud
Analog input/output (selectable voltage)
Digital input/output, serial communication interface (RS232)
AC Mains: 100-240 VAC, 50/60 Hz l 1A maximum consumption
H: 7.3 in. (185.4 mm) l W: 10.7 in. (271.8 mm) l D: 8.4 in. (213.4 mm)
Input: 0 to 1V, 0 to 5V, 0 to 10V l Output: 0 to 1V, 0 to 10V
USB Port: V1.1-compatible type A connector
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.
©2008 Edwards Lifesciences LLC. All rights reserved. AR03768
Visit www.Edwards.com/PreSep or call us at 800.424.3278 for more information.
Reinhart, K, et al. Continuous central venous and pulmonary artery oxygen saturation monitoring in the critically ill. Intensive Care Med 2004;30(8):1572-8.Rivers, EP, et al. Central venous oxygen saturation monitoring in the critically ill patient. Curr Opin Crit Care 2001;7(3):204-11.Ingelmo, P, et al. Importance of monitoring in high risk surgical patients. Minerva Anestesiol 2002;68(4):226-30. Scalea, TM, et al. Central venous oxygen saturation: a useful clinical tool in trauma patients. J Trauma 1990;30(12):1539-43.Ander, DS, et al. Undetected cardiogenic shock in patients with congestive heart failure presenting to the emergency department. Am J Cardiol 1998;82(7):888-91.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):1119-22.Rivers, E, et al. Early goal-directed therapy in the treatment of severe sepsis and septic shock. N Engl J Med 2001;345(19):1368-77.Pearse, R, et al. Changes in central venous saturation after major surgery, and association with outcome. Crit Care 2005;9(6):R694-9.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):218-25.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):450-1.Rivers, EP, et al. The clinical implications of continuous central venous oxygen saturation during human CPR. Ann Emerg Med 1992;21(9):1094-101.Loren, D. Continuous Venous Oximetry in Surgical Patients. Ann Surg 1986;203/3:329-333.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 2007,132:1817-1824.
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): 1368-77, Figure 2.Strategic tools for streamlining care and improving clinical effectiveness. COR Clinical Excellence 2002; 3(1):1-5.
1.
2.
3.
4.
5.
6.7.
8.
9.
10.
11.
12.
13.14.
15.
16.
17.
18.
References:
PreSepoximetrycatheter
PreSep Oligon†
oximetrycatheter
ModelDescription
Yes
OligonAntimicrobial
Material†
3
3
Lumens
16,* 20
16,* 20
Lengthcm
8.5 (2.83)
8.5 (2.83)
Size F(mm)
Yes
Yes
ContinuousScvO2
Lumen Size Gauge (mm)
0.032 (0.8)
0.032 (0.8)
MinimumGuidewire Size
inch (mm)
10.5(3.5)
10.5(3.5)
RecommendedDilator F (mm)
15(1.77)
15(1.77)
Distal
18(1.33)
18(1.33)
Proximal
18(1.33)
18(1.33)
Medial
*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 ScvO2. 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).
Presep oximetry catheter** specifications
Convenient, accurate and easy-to-use
• The first proven triple lumen catheter with continuous
ScvO2 monitoring
• Accurate versus CO-oximeter6
• Simple to use – uses same insertion techniques as
that of a central line
• Designed for use with Edwards oximetry monitors
and optical cables
Are your vital signs telling you everything?
PreSep oximetry catheter
•Upto50%ofcriticallyillpatients
resuscitated from shock may have
continued global tissue hypoxia
despite the normalization of vital
signs and CVP2
•Upto39%oftraumapatientshave
tissue hypoxia (ScvO2<65%)despite
stable vital signs4
High-risk surgery
Reductions in ScvO2 are common after major surgery and are independently associated with post-operative
complications.9 ScvO2 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
Earlytreatmentdirectedtomaintainextractionratioat<27%reduces organ failures and hospital stay of high-risk
surgical patients.15
• Heart failure
• Complex respiratory disease
• Coagulopathies
• Burns
• Trauma
• Sepsis
Intensive care
An ScvO2readingoflessthan60%onunplanned
admissiontotheICUwasassociatedwithhigh
mortality rates.14 TypesofICUpatientsaffected
include those with:
ScvO2 = Early Warning and Prevention
ECG
MAP
CVP
SpO2
ScvO2
Hemodynamic Trends150100509060301050
100
755025
ScvO2 monitoring of at-risk patients.The prognostic value of ScvO2
2 has been demonstrated in post-op high-risk surgeries,9 trauma,4 sepsis,8,10 cardiac
failure in CHF5,10 and recovery in cardiac arrest.11,12
Guides therapy and enables early intervention
• Continuous ScvO2 is a more sensitive indicator of
tissue perfusion compared to intermittent sampling
and traditional vital signs alone1-5
• Continuous ScvO2 monitoring reveals the true
adequacy of tissue oxygenation, enabling early detection
and assessment of clinical response to intervention1,2
• Continuous ScvO2 highly correlates and trends with
SvO21,2 while providing the same utility in monitoring,
which is essential in defining the adequacy of
cardiac output7
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:
• Reducein-hospitalmortalityby34%inadultpatientswithsevere sepsis and septic shock
when used with Early Goal-Directed Therapy2,8
• Reduce in-hospital length-of-stay by 3.8 days2,8
• Reduce hospital charges by $12,00018
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
Hospital Admission
Goals Achieved
YES
Transfusion of red cells until hematocrit ≥ 30%
< 70%
Inotrope Agents
≥ 70%ScvO2
2 Signs of the Systemic InflammatoryResponse Syndrome (SIRS)8
Temp C° < 36°C or ≥ 38°C l HR > 90 beats/minResp > 20 breaths / min or PaCO2 < 32 mm Hg
WBC > 12,000/mm3 or < 4,000/mm3or>10%immaturebands
Systolic BP ≤ 90 mm Hg or
Lactate ≥ 4 mmol/L
Sign of Global Tissue Hypoxia
Screen Early for At-Risk Patients
Vasoactive Agents< 65 mm Hg l > 90 mm HgMAP
Early Goal-Directed Therapy Treatment Protocol17
Crystalloid
Colloid< 8 mm HgCVP
Sedation, paralysis (if intubated), or both
NO
Central venous oximetry catheter andcontinuous arterial pressure monitoring
Supplemental oxygen ± endotracheal intubation and mechanical ventilation
CVPMAP
ScvO2
Central Venous PressureMean Arterial PressureCentral Venous Oxygen Saturation
8-12 mm Hg
≥ 65 mm Hg l ≤ 90 mm Hg
≥ 70% < 70%
Valuable time may be lost before traditional vital
signs or intermittent ScvO2 samplings indicate
tissue hypoxia – potentially delaying intervention
and putting the patient at greater risk.
Continuously monitoring central venous
oxygen saturation (ScvO2), through the PreSep
oximetry catheter, enables the early detection
and management of tissue hypoxia.1-5
PreSep Oligon oximetry catheter with integrated
antimicrobial protection†
0 Hour 1.5 Hours 3 Hours
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 ScvO2 monitoring is key to assessing the adequacy of the balance of
oxygen delivery and consumption. The goal of continuous ScvO2 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
Heart Disease
Contractility
Vascular Resistance
Afterload
Bleeding
Fluid Shifts
PreloadOptimal HR
HeartRate
StrokeVolume
BleedingHemodilution
Anemia
SaO2
FiO2
Ventilation
FeverAnxiety
PainShivering
Muscle Activity
MetabolicDemandHemoglobinCardiac Output Oxygenation
Oxygen Delivery Oxygen Consumption
ScvO2
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 www.Edwards.com/PreSep or call us at 800.424.3278 for more information.
An early warning indicator of tissue hypoxia.
Continuous ScvO2 monitoring with the PreSep oximetry catheter
Edwards Lifesciences LLC · One Edwards Way · Irvine, CA 92614 USA · 949.250.2500 · 800.424.3278 · www.edwards.com Edwards Lifesciences (Canada) Inc. · 1290 Central Pkwy West, Suite 300 · Mississauga, Ontario · Canada L5C 4R3 · 905.566.4220 · 800.268.3993
Edwards Lifesciences Europe · Ch. du Glapin 6 · 1162 Saint-Prex · Switzerland · 41.21.823.4300 Edwards Lifesciences Japan · 2-8 Rokubancho · Chiyoda-ku, Tokyo 102-0085 · Japan · 81.3.5213.5700
Vigileo monitor product specificationsColor Display
Power/Electrical
Trend Range
Size
Weight
PrinterCommunications
Medial
Bi-directionalPatient MonitorCommunications
5.2 in. (132.5 mm) x 3.9 in. (99.4 mm) TFT l 640 x 480 pixels
0.1 – 72 hours
6 pounds (2.73 kg) l IV pole-mount capability
Maximum data rate — 57.6 kilobaud
Analog input/output (selectable voltage)
Digital input/output, serial communication interface (RS232)
AC Mains: 100-240 VAC, 50/60 Hz l 1A maximum consumption
H: 7.3 in. (185.4 mm) l W: 10.7 in. (271.8 mm) l D: 8.4 in. (213.4 mm)
Input: 0 to 1V, 0 to 5V, 0 to 10V l Output: 0 to 1V, 0 to 10V
USB Port: V1.1-compatible type A connector
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.
©2008 Edwards Lifesciences LLC. All rights reserved. AR03768
Visit www.Edwards.com/PreSep or call us at 800.424.3278 for more information.
Reinhart, K, et al. Continuous central venous and pulmonary artery oxygen saturation monitoring in the critically ill. Intensive Care Med 2004;30(8):1572-8.Rivers, EP, et al. Central venous oxygen saturation monitoring in the critically ill patient. Curr Opin Crit Care 2001;7(3):204-11.Ingelmo, P, et al. Importance of monitoring in high risk surgical patients. Minerva Anestesiol 2002;68(4):226-30. Scalea, TM, et al. Central venous oxygen saturation: a useful clinical tool in trauma patients. J Trauma 1990;30(12):1539-43.Ander, DS, et al. Undetected cardiogenic shock in patients with congestive heart failure presenting to the emergency department. Am J Cardiol 1998;82(7):888-91.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):1119-22.Rivers, E, et al. Early goal-directed therapy in the treatment of severe sepsis and septic shock. N Engl J Med 2001;345(19):1368-77.Pearse, R, et al. Changes in central venous saturation after major surgery, and association with outcome. Crit Care 2005;9(6):R694-9.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):218-25.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):450-1.Rivers, EP, et al. The clinical implications of continuous central venous oxygen saturation during human CPR. Ann Emerg Med 1992;21(9):1094-101.Loren, D. Continuous Venous Oximetry in Surgical Patients. Ann Surg 1986;203/3:329-333.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 2007,132:1817-1824.
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): 1368-77, Figure 2.Strategic tools for streamlining care and improving clinical effectiveness. COR Clinical Excellence 2002; 3(1):1-5.
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References:
PreSepoximetrycatheter
PreSep Oligon†
oximetrycatheter
ModelDescription
Yes
OligonAntimicrobial
Material†
3
3
Lumens
16,* 20
16,* 20
Lengthcm
8.5 (2.83)
8.5 (2.83)
Size F(mm)
Yes
Yes
ContinuousScvO2
Lumen Size Gauge (mm)
0.032 (0.8)
0.032 (0.8)
MinimumGuidewire Size
inch (mm)
10.5(3.5)
10.5(3.5)
RecommendedDilator F (mm)
15(1.77)
15(1.77)
Distal
18(1.33)
18(1.33)
Proximal
18(1.33)
18(1.33)
Medial
*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 ScvO2. 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).
Presep oximetry catheter** specifications
Convenient, accurate and easy-to-use
• The first proven triple lumen catheter with continuous
ScvO2 monitoring
• Accurate versus CO-oximeter6
• Simple to use – uses same insertion techniques as
that of a central line
• Designed for use with Edwards oximetry monitors
and optical cables
Are your vital signs telling you everything?
PreSep oximetry catheter
•Upto50%ofcriticallyillpatients
resuscitated from shock may have
continued global tissue hypoxia
despite the normalization of vital
signs and CVP2
•Upto39%oftraumapatientshave
tissue hypoxia (ScvO2<65%)despite
stable vital signs4
High-risk surgery
Reductions in ScvO2 are common after major surgery and are independently associated with post-operative
complications.9 ScvO2 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
Earlytreatmentdirectedtomaintainextractionratioat<27%reduces organ failures and hospital stay of high-risk
surgical patients.15
• Heart failure
• Complex respiratory disease
• Coagulopathies
• Burns
• Trauma
• Sepsis
Intensive care
An ScvO2readingoflessthan60%onunplanned
admissiontotheICUwasassociatedwithhigh
mortality rates.14 TypesofICUpatientsaffected
include those with:
ScvO2 = Early Warning and Prevention
ECG
MAP
CVP
SpO2
ScvO2
Hemodynamic Trends150100509060301050
100
755025
ScvO2 monitoring of at-risk patients.The prognostic value of ScvO2
2 has been demonstrated in post-op high-risk surgeries,9 trauma,4 sepsis,8,10 cardiac
failure in CHF5,10 and recovery in cardiac arrest.11,12
Guides therapy and enables early intervention
• Continuous ScvO2 is a more sensitive indicator of
tissue perfusion compared to intermittent sampling
and traditional vital signs alone1-5
• Continuous ScvO2 monitoring reveals the true
adequacy of tissue oxygenation, enabling early detection
and assessment of clinical response to intervention1,2
• Continuous ScvO2 highly correlates and trends with
SvO21,2 while providing the same utility in monitoring,
which is essential in defining the adequacy of
cardiac output7
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:
• Reducein-hospitalmortalityby34%inadultpatientswithsevere sepsis and septic shock
when used with Early Goal-Directed Therapy2,8
• Reduce in-hospital length-of-stay by 3.8 days2,8
• Reduce hospital charges by $12,00018
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
Hospital Admission
Goals Achieved
YES
Transfusion of red cells until hematocrit ≥ 30%
< 70%
Inotrope Agents
≥ 70%ScvO2
2 Signs of the Systemic InflammatoryResponse Syndrome (SIRS)8
Temp C° < 36°C or ≥ 38°C l HR > 90 beats/minResp > 20 breaths/min or PaCO2 < 32 mm Hg
WBC > 12,000/mm3 or < 4,000/mm3or>10%immaturebands
Systolic BP ≤ 90 mm Hg or
Lactate ≥ 4 mmol/L
Sign of Global Tissue Hypoxia
Screen Early for At-Risk Patients
Vasoactive Agents < 65 mm Hg l > 90 mm Hg MAP
Early Goal-Directed Therapy Treatment Protocol17
Crystalloid
Colloid< 8 mm Hg CVP
Sedation, paralysis (if intubated), or both
NO
Central venous oximetry catheter andcontinuous arterial pressure monitoring
Supplemental oxygen ± endotracheal intubation and mechanical ventilation
CVPMAP
ScvO2
Central Venous PressureMean Arterial PressureCentral Venous Oxygen Saturation
8-12 mm Hg
≥ 65 mm Hg l ≤ 90 mm Hg
≥ 70%< 70%
Valuable time may be lost before traditional vital
signs or intermittent ScvO2 samplings indicate
tissue hypoxia – potentially delaying intervention
and putting the patient at greater risk.
Continuously monitoring central venous
oxygen saturation (ScvO2), through the PreSep
oximetry catheter, enables the early detection
and management of tissue hypoxia.1-5
PreSep Oligon oximetry catheter with integrated
antimicrobial protection†
0 Hour1.5 Hours3 Hours