an early warning indicator of tissue hypoxia. · edwards lifesciences llc · one edwards way ·...

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

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.

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.

13.14.

References:

PreSepoximetrycatheter

PreSep Oligon†

oximetrycatheter

ModelDescription

OligonAntimicrobial

Material†

Lumens

16,* 20

Lengthcm

8.5 (2.83)

Size F(mm)

ContinuousScvO2

Lumen Size Gauge (mm)

0.032 (0.8)

MinimumGuidewire Size

inch (mm)

10.5(3.5)

RecommendedDilator F (mm)

15(1.77)

Distal

18(1.33)

Proximal

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

Hemodynamic Trends150100509060301050

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

Transfusion of red cells until hematocrit ≥ 30%

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

Central venous oximetry catheter andcontinuous arterial pressure monitoring

Supplemental oxygen ± endotracheal intubation and mechanical ventilation

CVPMAP

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

Power/Electrical

Trend Range

Weight

Medial

0.1 – 72 hours

13.14.

References:

PreSep Oligon†

oximetrycatheter

ModelDescription

OligonAntimicrobial

Material†

Lumens

16,* 20

Lengthcm

8.5 (2.83)

Size F(mm)

ContinuousScvO2

0.032 (0.8)

inch (mm)

10.5(3.5)

15(1.77)

Distal

18(1.33)

Proximal

18(1.33)

Medial

ScvO2 monitoring

and optical cables

signs and CVP2

stable vital signs4

High-risk surgery

• Heart failure

• Coagulopathies

• Burns

• Trauma

• Sepsis

Intensive care

include those with:

755025

cardiac output7

Sepsis

Hospital Admission

Goals Achieved

Inotrope Agents

≥ 70%ScvO2

Crystalloid

Colloid< 8 mm HgCVP

CVPMAP

8-12 mm Hg

≥ 65 mm Hg l ≤ 90 mm Hg

≥ 70% < 70%

Power/Electrical

Trend Range

Weight

Medial

0.1 – 72 hours

13.14.

References:

PreSep Oligon†

oximetrycatheter

ModelDescription

OligonAntimicrobial

Material†

Lumens

16,* 20

Lengthcm

8.5 (2.83)

Size F(mm)

ContinuousScvO2

0.032 (0.8)

inch (mm)

10.5(3.5)

15(1.77)

Distal

18(1.33)

Proximal

18(1.33)

Medial

ScvO2 monitoring

and optical cables

signs and CVP2

stable vital signs4

High-risk surgery

• Heart failure

• Coagulopathies

• Burns

• Trauma

• Sepsis

Intensive care

include those with:

755025

cardiac output7

Sepsis

Hospital Admission

Goals Achieved

Inotrope Agents

≥ 70%ScvO2

Crystalloid

Colloid< 8 mm HgCVP

CVPMAP

8-12 mm Hg

≥ 65 mm Hg l ≤ 90 mm Hg

≥ 70% < 70%

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

Ventilation

FeverAnxiety

PainShivering

Muscle Activity

MetabolicDemandHemoglobinCardiac Output Oxygenation

Oxygen Delivery Oxygen Consumption

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.

An early warning indicator of tissue hypoxia.

Continuous ScvO2 monitoring with the PreSep oximetry catheter

Power/Electrical

Trend Range

Weight

Medial

0.1 – 72 hours

13.14.

References:

PreSep Oligon†

oximetrycatheter

ModelDescription

OligonAntimicrobial

Material†

Lumens

16,* 20

Lengthcm

8.5 (2.83)

Size F(mm)

ContinuousScvO2

0.032 (0.8)

inch (mm)

10.5(3.5)

15(1.77)

Distal

18(1.33)

Proximal

18(1.33)

Medial

ScvO2 monitoring

and optical cables

signs and CVP2

stable vital signs4

High-risk surgery

• Heart failure

• Coagulopathies

• Burns

• Trauma

• Sepsis

Intensive care

include those with:

755025

cardiac output7

Sepsis

Hospital Admission

Goals Achieved

Inotrope Agents

≥ 70%ScvO2

Temp C° < 36°C or ≥ 38°C l HR > 90 beats/minResp > 20 breaths/min or PaCO2 < 32 mm Hg

Vasoactive Agents < 65 mm Hg l > 90 mm Hg MAP

Crystalloid

Colloid< 8 mm Hg CVP

CVPMAP

8-12 mm Hg

≥ 65 mm Hg l ≤ 90 mm Hg

≥ 70%< 70%

0 Hour1.5 Hours3 Hours

an early warning indicator of tissue hypoxia. · edwards lifesciences llc · one edwards way ·...

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