Clearsight Clearsight

ClearSight System

No barriers. More Clarity.

ClearSight System

No barriers. More Clarity.

The ClearSight system extends the benefits of continuous hemodynamic monitoring to a broader patient population, including your moderate to high-risk surgery patients. 1,2,3  By leveraging proven Nexfin system technology, 4,23  the ClearSight system provides clinicians clarity without the barriers of complexity or invasiveness. 5
CLEARSIGHT SYSTEM

Noninvasive simplicity. Next-generation clarity.

The noninvasive ClearSight system provides valuable hemodynamic insight to an expanded patient population, for making more informed decisions about volume administration in moderate to high-risk surgery.1,2,3

Delivering clarity in every moment.

The ClearSight system quickly connects to the patient by wrapping an inflatable cuff around the finger.6 The simplicity of the ClearSight system gives you noninvasive access to automatic, up-to-the-minute hemodynamic information for a broader patient population, including elderly or obese patients in whom an arterial catheter would not typically be placed.  Thus, enabling you to make more informed decisions regarding volume administration.5

A simple, noninvasive approach to monitoring key hemodynamic parameters.

Dynamic and flow-based parameters such as SV and SVV, provided by the ClearSight system may be used in perioperative goal-directed therapy (PGDT) protocols and are key to optimal volume administration for patients at risk of developing complications.7

Clearsight finger cuff
Clearsight system technology
Clearsight finger cuff
Clearsight history
EV1000 Visual Clinical Support
Clearsight finger cuff

Clearsight system technology

Clearsight finger cuff

Clearsight history

EV1000 Visual Clinical Support

By leveraging proven Nexfin technology4,23 , the ClearSight system provides clinicians clarity without the barriers of complexity or invasiveness. 5 This technology has also been used as a standard for monitoring in space. 8

The Nexfin technology has been validated extensively through the years. 1,9 The Blood Pressure measurement has performed well against both intermittent noninvasive and continuous invasive methods. 4,10 Studies conclude that the Nexfin technology measures Blood Pressure according to the AAMI criteria 3 . Moreover, clinical data demonstrate that the Nexfin technology Blood Pressure is more accurate than a traditional upper arm Blood Pressure cuff when compared to invasive measurements in patients undergoing orthopedic surgery. 10

Similarly, the Nexfin technology Cardiac Output has been validated against several reference methods including pulmonary thermodilution, transpulmonary thermodilution, trans-esophageal/ thoracic echo-Doppler and inert gas rebreathing. Percentage errors range from 23% to 39%, which is comparable to more invasive methods. 4,10,12,13 Larger errors have been reported, but these occurred in critically ill patients where compromised flow to the finger may affect the Nexfin technology performance. 13

Beyond the ability to measure absolute Cardiac Output values, several studies have shown that the Nexfin technology is able to reliably track changes in Cardiac Output. As a result, studies have concluded that the Nexfin technology is a suitable monitor for the perioperative continuous measurement of Cardiac Output. 1,4,11

Blood Pressure Validation Studies

Vs. Noninvasive upper arm cuff   Patients  Bias ± SD
Nowak et al. – Am J Emergency Med 2011 20 40 ED patients  SYS -0.9±23.3/ DIA -2.5±8.1
Akkermans  et al. – Hypertension in Pregnancy 2009 21 33 pregnant patients  SYS  2.3±6.8/ DIA -2.5±8.1
Eeftinck Schattenkerk et al. – Am J Hypertension 2009 22 104 volunteers  SYS  4.3±9.3 / DIA -2.5±8.1
Vs. Invasive radial line 
Martina et al. – Anesthesiology 2012 23 50 cardiac surgery patients MAP  2.2±6.4
Fischer et al. – Brit J Anesthesia 2012 24 44 cardiac surgery patients  MAP  4.6±6.5
Martina et al. – ASAIO J 2010 25 18 patients during CPB   MAP -1.3±6.5
Kalmar et al. – ASA 2012 26 110 OR patients MAP  3.0±9.0

Cardiac Output Validation Studies

Vs. Pulmonary thermodilution  Patients Percentage Error
Bubenek-Turconi –  Anesth & Analg 2013 27 25 post CABG patients 39%
Bogert et al – Anaesthesia 2010 28 25 post CABG patients 30%
Stover et al – BMC Anesthesiology 2009 29 10 severely ill ICU patients 29%
Vs. Transpulmonary thermodilution     
Broch et al – Anaesthesia 2012 30 40 cardiac surgery patients 23%/26%
Monnet et al – Critical Care 2012 31 45 severely ill ICU patients 57%
Vs. Trans-thoracic echo-Doppler    
Van der Spoel et al. – J Clin Anesth 2012 32 40 ASA 1&2 patients 39%
Van Geldorp et al. – Europace 2011 33 23 CRT patients 15%
Vs. Esophageal echo-Doppler     
Chen et al. J Clin Anesth 2012 34 23 ASA 1-3 patients 37%

The Nexfin noninvasive technology was developed over the past 35 years and has been validated against other reference standard technologies. Beginning in the 1970s, finger arterial pressure was measured using finger cuff technology.1,9 

This technology was based on two methods:

  • The volume clamp method to continuously measure Blood Pressure9
  • The Physiocal method for initial and frequent calibration14 

The essence of the volume clamp method involves clamping the artery to a constant volume by dynamically providing equal pressure on either side of the arterial wall. The volume is measured by a photo-plethysmograph built into the cuff14.

The counter pressure is applied by an inflatable bladder inside the cuff and is adjusted 1000 times per second to keep the arterial volume constant.  Physiocal is the real-time method for determining the proper arterial ‘unloaded’ volume, i.e. the volume without a pressure gradient across the arterial wall. Physiocal analyzes the curvature and sharpness of the plethysmogram during short episodes of constant pressure levels. It then automatically and periodically recalibrates the system allowing accurate tracking of physiologic changes, e.g. in vasomotor tone.14

DescriptionModel No.
ClearSight Finger Cuff Small Multi Pack CSCS
ClearSight Finger Cuff Medium Multi Pack CSCM
ClearSight Finger Cuff Large Multi Pack CSCL
EV1000 Clinical Platform NI EV1000NI

Connectivity via IFM out through a serial connection, HL7 through an Ethernet connection or HL7 integration engine.

CLINICAL APPLICATION

For moderate to high-risk surgery patients who may not typically receive an arterial line, the next-generation ClearSight system offers a simple approach to monitoring key hemodynamic parameters, including: 2,3,5

  • Stroke Volume (SV)
  • Stroke Volume Variation (SVV)
  • Cardiac Output (CO)
  • Systemic Vascular Resistance (SVR)
  • Continuous Blood Pressure (cBP)
  • Valuable hemodynamic insight in moderate to high-risk surgery

With the integration of the next-generation ClearSight finger cuff into the EV1000 clinical platform, a single platform can now be utilized with both noninvasive and minimally-invasive hemodynamic monitoring options, such as the FloTrac sensor. The ClearSight system also sends an analog pressure to visualize noninvasive BP on a bed side monitor. 

30+ randomized controlled trials and 14+ meta-analysis have demonstrated clinical benefits of hemodynamic optimization over traditional volume management. 16-19   A large body of evidence demonstrates that hemodynamic optimization through Perioperative Goal-Directed Therapy (PGDT), utilizing dynamic parameters which are informative in determining fluid responsiveness, has been shown to reduce post surgical complications.

Hemodynamic Education

Edwards Critical Care Education

Edwards has been providing science-based education since 1972. We offer a full range of on-line, in-print and on-site programs that are available to your clinicians or staff.

Following are relevant educational tools:

Contact a Sales Rep

References:
  1. Bubenek S, Craciun M, Miclea I, Perel A. Noninvasive continuous cardiac output by the Nexfin before and after preload-modifying maneuvers: a comparison with intermittent thermodilution cardiac output. Anesthesia & Analgesia 2013; 117(2):366-72.
  2. Maguire S, Rinehart J, Vakharia S, Cannesson M. Respiratory variation in pulse pressure and plethysmographic waveforms: Intraoperative applicability in a north American academic center. Anesthesia & Analgesia 2011; 112: 94-96
  3. Martina J. Noninvasive continuous arterial blood pressure monitoring with NexFin. Anesthesiology 2012; 116: 1-12.
  4. Broch O, A comparison of the Nexfin and transcardiopulmonary thermodilution to estimate cardiac output during coronary artery surgery. Anesthesia 2012; 1-7.
  5. Truijen J, Lieshout J, Wesselink W, Westerhof B. Noninvasive continuous hemodynamic monitoring 2011. Journal of Clinical Monitoring and Computation; 4: 267-78.
  6. Eeftinck D. Nexfin noninvasive continuous blood pressure validated against riva-Rocci/Korotkoff 2009. American Journal of Hypertension; 22: 378-383.
  7. Michard F, Rational fluid management: dissecting facts from fiction 2012. British Journal of Anesthesia 108: 369-371
  8. Hughson R, Cardiovascular regulation during long-duration spaceflights to the International Space Station. Journal of Applied Physiology 2011; 112: 719-727
  9. Penaz J. Photoelectric measurement of blood pressure, volume and flow in the finger. International Conference on Medical and Biological Engineering. 1973; 1-3
  10. Sterr J, Comparison of the continuous noninvasive Nexfin monitoring system with conventional invasive methods to measure arterial blood pressure in high risk hip surgery. European Journal of Anesthesiology 2013;30: 35
  11. Chen G, Comparison of noninvasive cardiac output measurements using the Nexfin monitoring device and the esophageal Doppler. Journal of Clinical Anesthesia 2012; 24: 275-283
  12. Van der Spoel AG, Comparison of noninvasive continuous arterial waveform analysis (Nexfin) with transthoracic Doppler echocardiography for monitoring of cardiac output. Journal of Clinical Anesthesia 2012; 24: 304-309.
  13. Monnet X, The estimation of cardiac output by the Nexfin device is of poor reliability for tracking the effects of a fluid challenge. Critical Care 2012; 16:R212
  14. Wesseling K, Physiocal, calibrating finger vascular physiology for Finapress. TNO Biomedical Instrumentation 1995; 1-16
  15. Cecconi M, Fasano N, Langiano N, et al. Goal directed haemodynamic therapy during elective total hip arthroplasty under regional anaesthesia. Crit Care. 2011;15:R132
  16. Giglio MT, Marucci M, Testini M, Brienza N. Goal-directed haemodynamic therapy and gastrointestinal complications in major surgery: a meta-analysis of randomized controlled trials. Br J Anaesth 2009; 103: 637–46
  17. Dalfino L, Giglio MT, Puntillo F, Marucci M, Brienza N. Haemodynamic goal-directed therapy and postoperative infections: earlier is better. A systematic review and meta-analysis. Crit Care 2011; 15: R154
  18. Corcoran T et al. Perioperative Fluid Management Strategies in Major Surgery: A Stratified Meta-Analysis. Anesthesia – Analgesia 2012
  19. Bellamy, MC. Wet, dry or something else? B J Anaestha. 2006; 97(6): 755–757
  20. Nowak et al, The inability of emergency physicians to adequately clinically estimate the underlying hemodynamic profiles of acutely ill patients.  American Journal of Emergency Medicine.  2012; 30: 954–960
  21. Akkermans J, Continuous noninvasive blood pressure monitoring, a validation study of Nexfin in a pregnant population.  Hypertension in Pregnancy 2009; 28: 230-242
  22. Eeftinck D.  Nexfin noninvasive continuous blood pressure validated against riva-Rocci/Korotkoff. American Journal of Hypertension 2009; 22: 378-383
  23. Martina J, Noninvasive continuous arterial blood pressure monitoring with NexFin.  Anesthesiology 2012; 116: 1-12
  24. Fischer M,  Non-invasive continuous arterial pressure and cardiac index monitoring with Nexfin after cardiac surgery.  British Journal of Anesthesia 2012; 109: 514-521
  25. Martina J. Noninvasive blood pressure measurement by the Nexfin monitor during reduced arterial pulsatility: a feasibility study. ASAIO J. 2010 May-Jun; 56(3): 221-7.
  26. Kalmar AF, Validation of Continuous Noninvasive Arterial Blood Pressure Measurements During General Anesthesia, abstract presented at the Anesthesiology Annual Meeting, 2012
  27. Bubenek S, Craciun M, Miclea I, Perel A.  Noninvasive continuous cardiac output by the Nexfin before and after preload-modifying maneuvers: a comparison with intermittent thermodilution cardiac output.  Anesthesia & Analgesia  2013; 117(2):366-72.
  28. Bogert L, Pulse contour cardiac output derived from non-invasive arterial pressure in cardiovascular disease. Anesthesia 2010; 10: 1365-2044
  29. Stover J, Noninvasive cardiac output and blood pressure monitoring cannot replace an invasive monitoring system in critically ill patients.  BMC Anesthesiology 2009, 9:6  
  30. Broch O, A comparison of the Nexfin  and transcardiopulmonary thermodilution to estimate cardiac output during coronary artery surgery.  Anesthesia 2012; 1-7.
  31. Monnet X, The estimation of cardiac output by the Nexfin device is of poor reliability for tracking the effects of a fluid challenge. Critical Care 2012; 16:R212
  32. Van der Spoel AG, Comparison of noninvasive continuous arterial waveform analysis (Nexfin) with transthoracic Doppler echocardiography for monitoring of cardiac output. Journal of Clinical Anesthesia 2012; 24: 304-309.
  33. Van Geldopr IE, Comparison of a non-invasive arterial pulse contour technique and echo Doppler aorta velocity-time integral on stroke volume changes in optimization of cardiac resynchronization therapy.  Europace 2011;13(1):87-95.
  34. Chen G, Comparison of noninvasive cardiac output measurements using the Nexfin monitoring device and the esophageal Doppler. Journal of Clinical Anesthesia 2012; 24: 275-283

For Professional Use

For Professional Use

See instructions for use for full prescribing information, including indications, contraindications, warnings, precautions and adverse event.

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.

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