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Introduction
FORE-SIGHT development history How does it work? Animal and human validation studies p Comparison:
Difference between cerebral oximetry and pulse oximetry Difference between FORE-SIGHT and INVOS (Somanetics)
Clinical Studies
Adult cardiac surgery, elderly bypass, DHCA Adult non-cardiac major j surgery g y Orthopedic surgery (Beach Chair) Neonate: NICU and cardiac surgery (OR, CICU)
Grant Number 1R43NS039723-01 2R44NS039723-02 5R44NS039723-03 1R43NS045488-01 1R43NS046147-01 2R44NS045488-02 3R44NS045488-02S1 3R44NS045488 02S1 5R44NS045488-03
2R44NS045488-04A1 Chen, B
Arteries Tissue
(Arterioles, capillaries, venules)
Veins
TotalHb HbO2 Hb
VEN OCC ART OCC VEN OCC ART OCC VEN OCC ART OCC (min)
Light lost due to pulsation of arterial blood Light lost due to non-pulsating arterial blood Light Los st Diastole Light Lo ost Systole Li ht l Light lost td due t to venous bl blood d
Pulse Oximetry
Light lost from the Background: Light lost due to other molecules Light scattering lost
Cerebral O i Oximetry t
Time
Iol1 Iol2
Il1 Il2
photodetector
Hb
Beer ee - Lambert a be t Law a A = -log (I1 / Io) = * c * L
A2 A = attenuation (OD) Io = incident light intensity I = detected light intensity = specific extinction coefficient (M-1 * cm-1) c = concentration of absorbing compound (M) L = distance light enters and leaves solution (cm) ( (pathlength) hl h)
HbO2
A1 = (Hb1 * [Hb] + HbO21 * [HbO2] )* L = (Hb2 * [Hb] + HbO22 * [HbO2] )* L [Hb] = Deoxy-Hemoglobin Concentration [HbO2] = Oxy-Hemoglobin Concentration O2 Saturation SO2 = [HbO2] / ([HbO2]+[Hb]) Pathlength is not needed for calculate SO2
A = -log(I/Io) = * C * d * B + E
A is the optical attenuation in tissue at wavelength (units: optical density OD); Io is the incident light intensity (W/ 2); (W/cm ) I is i the th detected d t t d light li ht intensity i t it (W/cm (W/ 2); ) is i the th wavelength-dependent l th d d t absorption b ti coefficient ffi i t of f the th -1 -1 chromophore (OD * cm * M ); C is the concentration of chromophore (M); L is the light source to detector distance (cm); B is the light scattering differential pathlength factor (unit-less); E for non-hemoglobin optical losses (OD) which includes light scattering loss (OD), fixed background absorption (OD), and effect from patient dependent variables: such as skin tone, melanin (OD). For three independent wavelengths:
CASMED Patented P d algorithms: More wavelengths are needed to derive oxy and de-oxy hemoglobin concentrations in determining absolute SctO2, by accounting for background light lost.
A12 = (Hb12 * Hb + HbO212 * HbO2 )* d * B + E12 A13 = (Hb13 * Hb + HbO213 * HbO2 ) )* d * B + E13
A12 A13
[ ]
' 1
(d B )1
E12 E13
[ ]
' 1
(d B )1 =
Hb HbO2
INVOS: Two LEDs (bandwidth about 30 nm), insufficient wavelength to resolve the background light lost, and also are not precise enough to do absolute quantification.
FORE-SIGHT: Four precise laser diodes (bandwidth < 1 nm). From the NIH funded research, it was determined that four precise wavelengths are needed to maximize the measurement accuracy of oxy and de-oxy hemoglobin in determining absolute SctO2, by compensating for wavelength dependent scattering losses, and by accounting for interference from other background light absorbers.
The N Th Non-invasive i i Ad Adult lt C Cerebral b lO Oximeter i t M Model d l 2040 should h ld b be used as an adjunct monitor of regional hemoglobin oxygen saturation of blood in the brain of an adult. The Cerebral y should not be used as the sole basis Oximeter Monitor System for decisions as the diagnosis of therapy. The value of data from the Cerebral Oximeter Monitoring System has not been demonstrated in disease states. The noninvasive INVOS 5100 Cerebral Oximeter should be used as an adjunct monitor of trends in regional hemoglobin oxygen saturation of blood in the brain of an individual. Because INVOS values are relative within an individual, the INVOS should not be used as the sole basis for decisions as to diagnosis or therapy. The value of data from the INVOS has not been demonstrated in disease states. states
INVOS
FORE-SIGHT:
Animal Validation Study
FORESIGHT
JB Catheter
Pulse Oximeter
Cerebral oximetry measures cerebral tissue oxygen saturation (SctO2) at the microvasculature level (about 70% venous and 30% arterial blood), therefore SctO2 value is roughly 10% above jugular venous saturation under most clinical condition.
Comparision of Normal Cerebral Tissure Oxygen Saturation Values (Healthy ( y volunteers, awake, room air breathing) g)
70%
INVOS (rSO2) FORE-SIGHT (SctO2)
60%
50% 40% 30% 20% 10% 0% < 40 < 45 < 50 < 55 < 60 < 65 < 70 < 75 < 80 < 85 < 90
Case Report
A 78-year old female underwent aortic valve replacement procedure. In addition to standard monitors for cardiac anesthesia h i the h FORE-SIGHT FORE SIGHT Ab Absolute l Cerebral C b lO Oximeter i was utilized for monitoring cerebral tissue oxygen Saturation SctO2 with sensors placed bilaterally on the patients forehead. The pre induction SctO2 value was 55% and was drifting down to 50% post induction, and pre CPB. Since the FORE-SIGHT SctO2 value was low compared to what is normally seen for patients undergoing cardiac surgery, attempts were made to increase cerebral b l perfusion f and d oxygen d delivery l to maintain h her SctO2 level. It was soon determined that the low SctO2 reading was due to a low cardiac output (2 L/min) caused by server aortic valve stenosis, and this is confirmed by central venous saturation readings around 40s percent. Upon initiating CPB with full flow her status dramatically improved and her SctO2 level increased into the 70s and remained at this level until the end of the case.
CNMC: C C Blood ood sa samples p es d drawn a e every e y few e hours ou s a and da analyzed a y ed by laboratory co-oximeter. Variations of SpO2, SjvO2, and SctO2 obtained from ECMO weaning period and from long term data recording over 2 to 10 days for each patient.
Figure 2: Scatterplot of cerebral oximetry SctO2 vs. the reference SctO2 derived f from high hi h t temporal l resolution l ti monitoring it i of f Sj SjvO O2 from f in-line i li St Statsat t t monitor it and d pulse oximetry SpO2.
Summary
The significance of cerebral oximetry monitoring FORE-SIGHT SIGHT is better technology FORE
Disclaimer: I am one of the inventers of the FORE-SIGHT Absolute Cerebral Oximeter. Therefore, I can be biased.
St ar tp os t in du ct
Pr e by pa ss (n =1 5) Pl at ea u 20 de g C (n =1 0) H yp ot he rm a M ax (n =1 5)
D ee p
D HC A +5 m in (n =1 4)
D HC A +1 0 m in (n =1 4) (n =1 4)
D HC A +1 5 m in
D HC A +2 0 m in (n =1 (n A +3 D HC SC P En d st ud y/ ch es A 0 m +3 + 5 in m 15 tc 0) in =7 (n in m lo s in ur e
D HC A +2 5 m
D HC
SctO2% Average
) =4 (n
) =2 (n =1 (n
Cerebral Oximetry Monitoring of Patients Undergoing Elective Thoracic Aortic Surgery with DHCA and SCP (15 Subjects)
4) =1
4)
(A) Atherosclerotic ascending and arch aneurysm. (B) Fabrication of the trifurcated graft. (C) Selective cerebral perfusion and construction of the elephant trunk. (D) Completed repair.
Outcome of this patient: Extubated on the fifth day post surgery. Patient was severely confused - not oriented to person, place l or ti time. P Patient ti t h has a prolonged recovery. Absolute cerebral oximetry is useful in clinical settings to identify catastrophic events that may occur during the course of surgeries that would otherwise have been missed.
SctO2 failed to rise with cooling g on CPB in one patient p (out ( of 26 subjects). j ) The SctO2 variation corresponded to dynamic fluctuations of MAP, indicating an impaired cerebral auto-regulation for this patient. (Impaired cerebral autoregulation occurs often in people with advanced age, diabetes, hypertension, and existing cerebral vascular disease) Maintaining MAP at 50-60mmHg seems to be inadequate for certain patients. Cerebral oximetry is needed for tailored patient management during cardiac surgery
delivery using noninvasive cerebral oximetry decreases the incidence of stroke for cardiac surgical patients. Heart Surg F Forum . 2004;7(5):E376-81. 2004 7(5) E376 81
A large non-randomized series of 1698 cardiac surgical patients, comparison to an untreated comparator group of 2077 similar patients operated on in the immediately preceding 18-month interval. Cerebral oximetry was used to optimize and maintain intraoperative cerebral oxygenation oxygenation, a significant reduction in perioperative stroke rate, from 2.01 to 0.97%, was observed.
Orihashi K, et.al., Near-infrared spectroscopy for monitoring cerebral ischemia during selective cerebral perfusion. Eur J Cardiothorac S Surg . 2004 N Nov; 26(5):907-11. 26(5) 907 11
A sustained decrease in rSO2 was observed in patients with infarcts suggestive to hypoperfusion. Transient neurological events occurred more frequently in patients with sustained i dd drop b below l 55% f for over 5 min. i Recommend that recovery of drop in rSO2 below 55% should be addressed without delay.
Intervention Protocol
Goldman S, et al, Optimizing intraoperative cerebral oxygen delivery using noninvasive cerebral oximetry decreases the incidence of stroke for cardiac surgical patients. Heart Surg Forum. 2004;7(5):E376 2004;7(5):E376-81 81. Murkin JM, et al, Monitoring brain oxygen saturation during coronary bypass surgery: a randomized, prospective study. A Anesth h Analg. A l 2007 Jan;104(1):51-8.
Lessons Learned:
Challenges of a for Patient Monitoring Technology Different Era compare to the time when Pulse Oximetry was adopted by clinicians: Evidence-Based Medicine: Can it improve p patient p outcomes Benefit/Cost: reimbursement issue; Hospital administration demands More outcomes data support the use of NIRS in children than exist for pulse oximetry Clinical Research Driven Marketing: Success of Masimo, Aspect Medical.
Figure Top Left: Recorded SctO2 values from FORE-SIGHT cerebral oximetry monitoring with bilateral forehead sensors obtained from three patients, with methylene blue administration timing shown. Conclusion: Our results suggest that the FORE-SIGHT cerebral oximeter can be used to reliability detect brain oxygen desaturation events in cases where Methylene Blue is administered to treat vasoplegic syndrome. From: FORE-SIGHT Cerebral Oximeter: A Possible Solution to Methylene Blue Interference Gregory W. Fischer, M.D. and David L. Reich, M.D. Department of Anesthesiology, Mount Sinai Medical Center, New York (publication pending)
Figure Bottom Left: Concomitant with the initiation of the methylene blue loading dose, we noted that cerebral oximetry values (INVOS, Somanetics, Troy, MI) declined markedly in all patients despite significant improvement in systemic perfusion pressure. The image on the bottom left illustrates this phenomenon in two patients by replicating the INVOS monitor display. From: Mittnacht AJ, Fischer GW, Reich DL. Methylene
blue administration is associated with decreased cerebral oximetry values. Anesth Analg. 2007 Aug;105(2):549-50.
There is a question why the word absolute doesn't appear in the FORE-SIGHT indication for use. The answer: For a patient monitor, absolute is assumed unless marked as trends. For example, below is the "Indications For Use" of a Nellcor Pulse Oximeter. It is "for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate." Notice that there is no word "absolute" in this indications for use . But nobody will doubt that the SpO2 and pulse rate that this Nellcor pulse oximeter provides are ABSOLUTE values.
Comparison of NIRS SctO2 vs. Blood Co-oximetry in Neonatal Pig Models with Intact Scalp and Removed Scalp (NIRS Probe optode separation = 25 mm)
Figure: Mean, 25th-75th Percentile boxes for Median LRAvg Cerebral tissue saturation at standardized event times (shows data from Table 1 )
Data are from the INVOS flip chart FORE-SIGHT: Median SctO2 value of awake cardiac surgery patients was 70%. Awake SctO2 variability was small (SD:3.9%, 2SD:62.2 to 77.8%, actual range 60.6 to 83%) independent of age, skin color and gender. (Macleod et al: ANESTH ANALG 2007; 104; S129) INVOS: Baseline rSO2 were 669%, range (defined as 2SD) was 48 to 84%. Actual range on figure were from <40 to <90%, Six percent of patients has baseline rSO2 value less than 50% - the suggested intervention threshold by Somanetics.
Table 1: Bilateral Difference of Absolute SctO2 Room Air Breathing O2 100% O2 100% +10 min Induction Induction +15 15 min Incision Incision +15 min Pre-CPB -5 min CPB on +10 10 min i CPB on +30 min Start Rewarming Pump Off End CPB +20 min Chest Closed
Average 1.8 2.1 1.8 2.5 2.4 2.3 2.5 2.5 26 2.6 2.7 2.4 2.6 3.0 2.8
Standard Deviation 1.2 1.3 1.4 1.6 2.0 2.2 2.4 1.9 20 2.0 2.4 2.3 1.8 1.9 2.2 Frequency 206 135 50 21 4
Max 4.0 4.1 5.1 5.6 8.5 7.9 10.3 8.3 71 7.1 7.5 9.6 6.5 7.6 7.1
INVOS validation lid i data d ( (chart h shows h on the h Somanetics webpage). Result is the comparison of TREND values changes of rSO2. (1) The Y axis value is rSO2, here indicates it is change of rSO2 (2) Value is marked from (-) to (+) indicates the chart shows only change of rSO2
Some presentations cite the Kims (Ref 1) study for INVOS validation (see charts above). Fig. 3 compare jugular bulb O2 saturation SjvO2 with rSO2. SjvO2 and rSO2 are not the same parameter. The correct way is to compare rSO2 with fSO2 [fSO2 = a*SaO2 + (1(1 a)*SjvO2, )*SjvO2 see page197]. Here the data of this paper starts to fall apart. (See Fig 5. the distribution of a.) I dont believe that Kims paper included subjects that outliers (see next two photos, one is tested on the brand new INVOS.) But the same groups earlier study found that was a problem ( p (ref 2 Fig g 2). ) Next two photos show that the new INVOS has the same problem. The bottom line is the principle of physics says that you need one wavelength for one unknown absorber. A two wavelengths system like the INVOS can not resolve Hb, HbO2 and as the same time figures out what is the background light lost. So INVOS only can do TREND. ).
1. 2. Kim M, Ward D, Cartwright C, Kolano J, Chlebowski S, Henson L: Estimation of jugular venous O2 saturation from cerebral oximetry or arterial O2 saturation during isocapnic hypoxia. J Clin Monit 2001;16:191-99. Henson LC, Calalang C, Temp JA, Ward DS. Accuracy of a cerebral oximeter in healthy volunteers under conditions of isocapnic hypoxia. Anesthesiology. 1998 Jan;88(1):58-65.
Figure 1. Graphic depiction of temperature: time Figure 2. Graphic depiction of temperature: time relationship p during g cardiopulmonary p y bypass yp and deep p relationship p during g cardiopulmonary p y bypass yp and deep p hypothermic circulatory arrest for patient 14. hypothermic circulatory arrest for patient 18. Monitoring Temperatures from each monitoring site are plotted site temperatures are plotted every minute. Central sites every minute. Central sites are nasopharynx, tympanic are nasopharynx, tympanic membrane, esophagus, and membrane, esophagus, and pulmonary artery. pulmonary artery. Peripheral sites are bladder, rectum, Peripheral sites are bladder, rectum, axilla, and sole of axilla, and sole of the foot. The two slowest cooling central th f the foot. t Th The t two f fastest t t cooling li sites it were pulmonary l t l sites it were t tympanic i membrane b and d esophagus. h artery and esophagus. Stone, J. Do Standard Monitoring Sites Reflect True Brain Temperature When Profound Hypothermia Is Rapidly Induced and Reversed? Anesthesiology: 82(2), 1995:344-351
Nussmeier NA, Temperature during cardiopulmonary bypass: the discrepancies between monitored sites. Anesth Analg. 2006 Dec;103(6):1373-9. temperatures measured in body sites overestimated JB temperature during cooling and under-estimated d i di it d during i rewarming, i whereas h arterial outlet blood temperature provided a good approximation. Is the conclusion correct?
Akata T, Changes in body temperature during profound hypothermic cardiopulmonary bypass in adult patients undergoing aortic arch reconstruction. J Anesth. 2004;18(2):73-81. the CPB venous line temperature (CPBT), a reasonable indicator of mixed venous blood temperature during CPB and believed to best reflect core temperature d i during stabilized t bili d h hypothermia th i on CPB (pulmonary arterial temperature) PAT began to change immediately after the start of cooling or rewarming, closely matching the CPBT ( r = 0.98). a PA catheter thermistor, thermistor presumably because of its a placement immediately behind the superior vena cava, would provide a reliable measure of the mixed venous blood temperature.
Leyvi G, Bello R, Wasnick JD, Plestis K. Assessment of cerebral oxygen balance during deep hypothermic circulatory arrest by continuous jugular bulb venous saturation and near-infrared spectroscopy. J Cardiothorac Vasc Anesth. 2006 Dec;20(6):826-33.
From: Wernovsky G,et. et al al., Hypoplastic left heart syndrome: consensus and controversies in 2007. Cardiol Young. 2007 Sep;17 Suppl 2:75-86. Survey of f 52 large l pediatric d h heart surgery center (US and International)
Pulse oximetry: Assume the pulsatile signal (alternating current - AC) comes only from artery. Background light lost is in the direct current (DC) components Normalization AC/DC to cancel out the effect DC. Therefore, pulse oximetry is not affected by b k background d light l h lost. l Two wavelengths l h are sufficient to resolve SaO2.