throbber
I
`
`1
`
`I
`
`I
`
`.
`
`I
`
`Original Articles
`
`‘:1:
`
`.;
`
`.
`
`.
`
`.
`
`,,l[.-
`
`Nikofnirs -Gl:¢1i;(’J'ls.f€l"li', MD, iwmi @Eni.§inrkfle¢1:‘L MD
`.E..':
`i'_I.e '»§'!‘.--
`.":
`._,.
`'..
`'.":- 3-.
`3::-Ii
`'.'.—_.
`,"
`-
`'
`'
`.
`XI’.
`il’IL’fl(i'Pi5p.'l.l_i;’i!D. and . McGfmi_,_ MSr
`
`7
`
`:3
`
`'
`
`...
`—'-f.3..".':=...'...-..'.I
`.'
`“II--i-.I.
`i\IIi(hae|' S. Corback, 1"/ID, Tiinoriiyj. Qm'H, IMD,
`and Mirimei L. Lrwiire, PhD
`
`olmne 7 Number 1 January 1991
`
`23
`
`.;_-_"
`
`"I-:
`.-r-.
`
`'
`
`_..
`
`|
`
`.-u-
`
`-_I-
`
`i.'_n'I
`
`Dr‘:-rizs, Dr med,
`
`CLINICAL SCIENCES cemen Liam
`UNWERSITY OF WISCONSIN
`500 HIGHLAND AVEJ MHDISUN. WI 537
`
`1 ?
`
`-
`
`..
`
`9’-"‘~’ R“{fi°,f”‘_,
`;'.;gg.[_.|‘_n
`:‘:.""
`L
`.".'~‘I."!.
`i
`'.
`Taieofo Morioko. MD. Kiyomien Flrfli, MD,
`Simzo Tobimarsn, MD, Masashi Fuimf, MD,
`niiri YosiriI'o SakngIl_eiri,___MD
`l|J..
`
`I.“
`
`s. K. C'2n.i:ifirf,.1\.vI"Di,-I*'F.:'-’ii‘i2CS, Cimmi A. Matrisili, MD,
`Robert (__.‘ooIi_,_PiiD,__ and Am: Ba:'deerI_-Heii_sciIei_,_
`I.'I"'.-’r:;-';-'-'~.
`'
`-
`'-'.-n=-n:- -'
`:'-'-.
`~‘.'f!1r:.iI'i{‘:';:’
`.And"erso.n,
`W yue
`i'I.rID,=
`Brorie-Ung, £FA(SA}
`Technical Notes
`
`-'
`
`:'=.'-5:2’ L-,:I.t_.;:.:.
`
`.
`
`€¥§§?!e.v%i._J»
`'
`
`|.5'
`
`'
`
`-
`
`i..
`
`§?T!'.'?.’..'.‘!!!.».. i_'*:1'!?_>..-...r*_?1*’._¥§9~.‘=sI._$£=.es?3.!!§!r.r:e. MS _
`!
`.-
`'..:==- ‘l*
`-‘
`'J'..
`-. —=1'.':s
`:1
`‘I:
`.'l.
`--.;*.‘..'1J.'.
`
`u.--.-.
`
`join: Bernard Valdnqhi, MD. mm‘ Pruririe i\_Vewinirri Nome, MD
`Knowing Your Monitoring Equipment
` .-. I -,
`
`-in -:.'.~:£_-"HJ.-1-;--:....,—
`
`..
`
`-5.5
`
`A*In;i:roi'if Rdlllfff H{_,_i'I/ID. PhD
`68 Corresponcfence
`70 Books
`Workshop
`.
`.
`john
`iE'ii‘iiiioru, MD, cmri Drwiri W. Erisoii, MD
`Abstracts of Scientific Papers
`ii I
`. ‘
`.. IT ._
`'.
`I”
`'
`
`.i.
`
`_ Z.
`
`7:
`
`8.3
`
`I02
`
`.
`
`.
`
`.:.|..
`
`,-1-16 Annozmcements
`34
`
`._
`
`.
`
`-'
`
`..
`
`..
`
`A40
`
`A-15 I
`A-I6
`
`'
`
`'
`
`3
`
`.32:-HNALlJF_IHE—S[I[:lETY
`' -'~-'iflGY_.lN_P*"E5T.HE3'A
`
`-
`
`= "
`
`_
`_
`Apple Inc.
`Apple Inc.
`APL1013
`APL1013
`U.S. Patent No. 8,989,830
`U.S. Patent No. 8,989,830
`
`I
`
`

`
`JOURNAL OF GL|NIBAL_MOH|T0ill|llli
`
`Volume 7 Number 1 January 1991
`
`JAN17 1391
`
`Hrrnclat Jounmn at THE socltrr F[fH_fEEHl0l{|fiY HI Auasrursn
`ELI
`iliiii
`N. Ty Smith, MD
`University of California. San Diego
`VA Medical Center
`San Diego. California
`
`J-.['Il'fl]lil.~'J.l_ lll]ilFli'I
`Paul G. Barash, MD. New Haven, Connecticut
`Charlotte Bell. MD. New Haven, Connecticut
`
`jan E. W. Bertcl-ten, PhD, Eindhovcn, The Netherlands
`Casey D. Blitt, MD, Tucson, Arizona
`jetty M. Calkins. MD, PhD, Phoenix, AZ
`Henry Casson. MD. Portland. Oregon
`Jeffrey B. Cooper, PhD. Boston. Massachusetts
`D. Daub, MD, Karlsruhe. Germany
`Edward Dclatid, MD, Los Angeles. California
`Peter C. Duke, MD. Winnipeg, Manitoba, Canada
`john H. Eichhorn, MD, Boston, Massachusetts
`Erich Epple, PhD, Tiibingcn, Germany
`A. Dean Forbes. Palo Alto, California
`
`Wesley T. Frazier, MD. Atlanta. Georgia
`Yasuhiro Fukui, PhD, Hatoyama, japan
`Leslie A. Geddes. ME. PhD. FACC. West Lafayette, Indiana
`Nikolaus Gravenstein, MD. Gainesville, Florida
`A. Gerson Greenbutg, MD. PhD, Providence, Rhode Island
`Betty L. Grundy, MD, Gainesville. Florida
`H. _l. Hartung, MD. Mannheim, Germany
`Carl C. Hug, jr. MD, Atlanta. Georgia
`Kazuyuki Ikeda, MD, PhD, I-laman1atsu._]apan
`_]oel Karlincr, MD, San Francisco. California
`John D. Michenfclder, MD, Rochester, Minnesota
`P. M. Osswald, PhD, Mannheim. Germany
`Tsutomu Oyama, MD, Hirosaki, japan
`Carlos Parsloe, MD, Sao Paulo, Brazil
`jan Pefiaz, MUDr, CSc, Brno. Czechoslovakia
`james H. Philip, ME{E). MD. Boston, Massachusetts
`Richard E. Piazza, PhD, Bcllcvuc, Washington
`Ellison C. Pierce, jr, MD, Boston, Massachusetts
`Cedric Prys-Roberts. MA. DM. PhD, FFARCS. Bristol, UK
`Michael L. Quinn, PhB, San Diego, California
`Ira]. Rarnpil, MD, San Francisco. California
`Maynard Ramsey III. MD. Tampa, Florida
`Charles L. Rice. MD. Seattle. Washington
`Michael F. Roizen, MD, Chicago. Illinois
`Helmut Schwilden, MD, PhD, Bonn, Germany
`john W. Severinghaus, MD, San Francisco, California
`Lewis B. Sheiner, MD. San Francisco, California
`
`David B. Swedlow, MD, Hayward, California
`Richard Tcplick. MD. Boston. Massachusetts
`Kevin K. Tremper, PhD. MD. Orange, California
`Max I-I. Weil, MD, Chicago, Illinois
`Arnold M. Wei-ssler, MD, Denver, Colorado
`
`Karel H. Wesseling. PhD. Amsterdam. Holland
`
`_|. S. Gravenstcin. MD
`University of Florida College of Medicine
`Gainesville, Florida
`
`Allen K. Ream, MD
`Stanford University School of Medicine
`Stanford, California
`31
`.. ['!E'd'lliW lllill 'fEl.lilJfllltllVlUllil3i\TlfiPiS ftflllflil
`Frank E. Block. _]r, MD. Columbus, Ohio
`In .'IL"l55i'l‘lil3.'llllE lil‘-lffifl
`Robert K. Kalwinsky
`Fl.
`'
`‘.i'il"lEH
`Little, Brown and Company. Boston, Massachusetts
`Pl
`'
`"
`-."':'irlll\lI.‘: STIXIFF
`
`Lynne Herndon, Publisher
`Christine F. Lamb, Executive Editor
`Mary B. Donchez, Managing Editor
`Sherri Frank, Editorial Assistant
`Fredda Purgalin, Production Manager
`Anne Orens, Sales and Marketing Manager
`jounml afCi'iuira1l' Mottttoriitg. ISSN I'.]lr"1B-197'.-'. Published four times a year, in
`january. April. July. and October by Little. Brown and Company. 34 Beacon
`Street. Boston, MA 02108-I493. Send address changes and subscription or-
`ders to Little. Brown and Company. Subscription Dept. PO Box 2033.
`Langliorne. PA 19047-9480: (800) 628-4221. Subscription rates per year: Per-—
`sonal subscription. US and possessions. $89.00; foreign (includes Mexico].
`S12-1.00; Canada. $98.00; Institutional, US, 5110.00; foreign. 5139.00; Cana-
`da. $115.00. Special rates for students. interns. and residents per year: US.
`$65.00: foreign, STE00: Canada. 573.00. Single copies, 523.00 prepaid. In Ja-
`pan please contact our exclusive agent: Medical Sciences International. Ltd,
`I-2-I3 Yusltinta. Bunltyo—ku. Tokyo I13. japan. Subscription rates per year
`in japan: individual. Y23, I00: institutional, Y27.'.-'0t] (air cargo service only).
`POSTMASTER: Send address changes to jtmrml of Clltttrfll Mnttitarirlg. PO
`Box 2033, Langhotne. PA 1904?-9480.
`Copyright ® i991 by Little. Brown and Company (Inc). Ml rights reserved.
`Except as authorized in the accompanying statement. no part of thejottriml of
`Clitiiral Mortitaritig may be reproduced in any form or by any electronic or
`mechanical means. including information storage and retrieval systems. with-
`out the publisher's written permission. Authorization to photocopy items for
`internal use. or the internal or personal use of specific clients. is granted by
`Little. Brown and Company. inc. for libraries and other users registered with
`the Copyright Clearance Center Transactional Reporting Service. provided
`that the pet-copy fee of 51.50 is paid directly to the Copyright Clearance
`Center. 2? Congress St. Salem. MA (119730. for copying beyond that permit-
`ted by Sections 10? or 103 of the U.S. Copyright Law. The code fee for this
`journal is D".-"*l3~l9??f9l 51.50. This authorization does not extend to other
`kinds of copying. such as copying for general distribution. for advertising or
`promotional purposes. for creating new collective works. or for resale.
`The authors. editors. and publisher have exerted every effort to ensure that
`drug selection and dosage. as well as the description of instruments and rec-
`ommendations for their use. set forth in all articles appearing in the Jaimie!‘ of
`Cfiitirttl tlafniiitnrirtg are in accord with current reconunendations and practice
`at the time of publication. However. many considerations necessitate caution
`in applying in practice information reported in any article appearing in the
`Jnunirll. These include ongoing research. changes in government regulations.
`variations in standards among different countries. the possibility that original
`research as reported in thejolmlel may differ from standard practice. and the
`constant flow of information relating to drug therapy and drug reactions. as
`well as the principles of monitoring. application of instruments. and differ-
`ences in instruments among manufacturers. The reader is advised to check
`the package inserts for each drug for change in indication and dosage. and the
`descriptions provided by instrument manufacturers for added warnings and
`precautions. This caution is particularly important when the recommended
`drug or instrument is new or infrequently employed.
`The Jottrttal afCliniral' Moitftnring is indexed in hltfrx M'etlfrItr, Cmrent
`Cnrttt-nts;‘Cl|‘m‘mI Pnmirr. Exrrrpra Metlirrt. and Current! Auram-less in
`Biological Sriritrrs.
`
`l l l I I
`
`II
`
`

`
`JOURNAL OF CLINICAL MONITORING
`
`Volume 7 Number 1 January 1991
`
`Ortgmal Articles
`IN IIITRO EIAIRLUETIOII OF HELITIVE PEIIFOFINIIIIII PUTENTIIII.
`OF OENTIUIL VENOUS CIITIIETEH31 CONIPDRISON UF
`MDTEIIIDLS, SELECTED HUI}-EL5. NUIIIBEII OF LUMENS, MID
`fiN{iI.E5 [IF INCIDENCE TU SIMIJIJTEO MEMBIIDNE
`Nikolaus Cravertstefll, MD, and Robert H. Bfadesllear, MD
`SKIN HEFLECTANBE PULSE OXIMETBY:
`IN FWD MEASUREHENT5
`FHDM THE FDHEAIIM AND CALF
`
`Y. Mendelson, PhD, and M. J. Mr:Gr'rm. MS:
`
`_
`THE FIEIJITWE ACCUMCIES OF TWO AUTDHRTEO
`NONIIIWASIIIE ARTERIAL PHESSIIIIE MEASUREMENT DEVICES
`Michael S. Gorback, MD, Tfmotlay J. Quill, MD,
`and Michael L. Lauine, PhD
`
`ELECTFIDENCEPIIALOGRJIPHIC MIIPPIIIG DURING ISOFIMRANE
`AIIESTHESIA FOII TREHTMENT OF MENTAL DEPRESSION
`
`W. EugeIIIara'r, Dr med, C. Can‘, Dr Med,
`T. Dierks, Dr med, and K. Maurer, Prof Dr med
`
`Case Reports
`IISEFUUIESS OF EPIIJUIIALLY EUOKED GDHTICAL PDTEIITIM.
`MONITORING DURING CEHUICOMEOIILLAIW CLIOMD SURGERY
`Tafearo Moriolea, MD, Kiyotaka Fqjfi, MD,
`Sfrazo Tobfalatsts, MD, MHMSIII Fukui, MD,
`and Yoshiro SaIeagueIu', MD
`CAPNDGRAPHY FOR DETECTION [IF ENDDBRDNCHIAJ.
`MIGFIMIDN DF AN ENDDTRACHEILL TUBE
`S. K. Gandhi, MD, FFARCS, Charm‘ A. Mmishi, MD,
`Robert Coon, PIID, and Am: Bardeen-Heusdael, MD
`OXYGEN PIPEUIIE SUPPLY FMLURE:
`£4 COPIIIG STMTEGY
`
`Wayne R. Anderson, MD, and Jofm C. Brock-Ume, FFA(SA,I
`
`Technical Notes
`A TARGET FEEDBDCK DEVICE FOR VENTILMOIW MUSCLE
`TRAINING
`
`Michael _I. Behuan, MD, and Reza Shadmehr, MS
`49 REDUCTION OF FRESH [HIS FLOW IIEIJUIFIEIIIENTS BI‘ A
`CIRCLE-MODIFIED BMII BIIEIITIIIIIG CIRCUIT
`
`_,Io.Im Bernard Voldnlghi, MD, and Patrick Newfand Nance, MD
`
`Knowing Your Monitoring Equipment
`55 moan enessune Mnmroamn: AUTOMATED nscluomermc
`DEVICES
`
`Maynard Ramsey III, MD, PIID
`Correspondence
`68 LOW PEHFIJSIDII PIIIESS-‘DRE OH IHTERIIIIPIIDN {IF BLDIJD FLDIT
`SUPPIIESSES ELECTROENCEPHALDSHAPHIC ACTIVITY?
`forge Urzrm, MD
`68' HEPLY
`
`Mark S. ScI':eIIer and Brian R. Jones
`68 HEASUFIEMENT UF MITEHIIIL UIWUEN TENSION IN THE
`HTPEFIBI-IRIS ENVIRONMENT
`Lindefl K. Weaver, MD
`
`HEP-L9
`Dr. G. Litseher
`
`Books
`70 CM-‘IIO’J8.APHY IN CLIIIICIII. PIIACTICE
`
`]. S. Gravcnstein, MD, David A. Paulus, MD. MS, and
`Thomas j. Hayes. BS
`B. Smafhour, MD, PIID
`
`C'omems rormimed on page 21-4
`
`III
`
`

`
`Cements :onn':medjPam page A-2
`
`Workshop
`71 OOHPIITERIIQHDR OF MIESTHESIA IIIFBHMJFHDII
`MMIAGEHEHT
`
`john H. Efchhorn, MD, and David W. Edsalf, MD
`Abstracts of Scientific Papers
`33 mun MEDICAL HDIIITIIIIIIIII TEE!-IIIIJLIJBY BHFEBEIICE
`
`1192 HRS? Mlllllhl MEETING (IF THE SOCIETY FOR TECHNOLOGY Ill
`AHESTHESM
`
`-
`
`A-I6 Announcements
`
`34 name man In: EBITIJBS
`
`21-10 IIIFIJRMATIGH run comnnamuns
`
`21-15 THE suclm FDB TEDHHDLDGY IR AHESTI-IESIA
`
`A-16 musx Tn nnvsnnsaas
`
`IV
`
`

`
`This material may be protected by Copyright law (Title 17 U.S. Code)
`
`

`
`9.9.99:9:9:9:9._9999933'3’?..9.99 9
`9
`.C
`99
`9’.3I*
`::-+
`99.99
`-9 '9:3:99 -9.99 .9.99:9.9:9‘’ 9.9.99.99
`9'.
`'9’... 99.9.999.9.99.999 C. .0
`9 .9-:.9‘9
`
`9'9‘9'99999‘9°999‘9''9'9999:9:99I3'3':39.9.9
`999,9_ 3:99 9
`'9‘9’9‘9‘9':’:9'-°9'9‘9’9*9‘9°9°9°99‘-999.9.9.9.9.999"99999.59.9.99999999‘9’9‘.9.9.9.9,9.9.93t$;2:2;Z:2;29.9.9.9.:
`.9'.9'.9g9'9'9’9‘99999‘9‘9‘9‘_9,9.9,9.9.9.9,99,9.9.9.9.9,9,9.‘0Q9CO‘O‘,9:9:9:9:9:9‘9
`
`9‘99 9.99 9.99 9.9.
`
`9 9
`
`9
`::::‘.'99'z:--
`9
`9
`999:99.99,9999':
`99:3:999:9:§09‘9‘999.9 9
`9
`3'39'99:99,:9.9
`99
`999,9.9.:*3‘3°3°3°39°9°9"9‘9’9-’9‘9’9’9°9‘9".9_,_9.9.9.9.9'*~t«:»:,.
`9
`9
`9..3'3’
`5»:
`.0
`,9 .9203
`O
`‘'99:9’9:0O.
`9’.9
`,v o::3:'.9.9.9,9'9‘9‘9‘9‘9°9"9999999‘’9'9,:9.9 9
`9I9°.-999'9'9'9°9’9"9
`
`'9OCO0§‘\‘9’9°9°9*9’9':°99\/9’9'9"9°9°9‘9’9'9'\99'9-"9‘9’9‘9‘9‘
`'9‘9:9:9:9:9:9
`
`‘o‘§a:9:9:9:9:9:9:9°9°:’ 99
`$::9:9‘:‘9'9:9:9:9’9999999999
`9.9.939_9I9f
`§:°9:9'9:9’9’
`
`9 9
`
`O:
`
`OPTICM. SHIELD
`
`R ‘
`
`IR LED‘
`
`PBOTODIODE5
`BRASS RING
`
`PHOTODIODES
`OP'1'ICh.l'..LX
`CLEAR E9 OX!
`'
`,..._...__.._.
`R\\“\\‘
`TEEEMOFOIL
`' ' ' r:v:o.a ooo.I 7‘
`Egg-1-E
`_'s\\\\".'.“.:
`-
`H“ i "I"
`y////an//hi/J//J sxr-Ic:m
`RUBBER
`B
`
`..
`
`Fig 1. (A) Fnmral and (B) side rriews u_f'.'lrr' lrrared slain rr3‘irr—
`tame pulse oximeter sensor. See rexrfur rxplanan'un. ll 8: IR
`LEDs = red mid in_fim‘en‘ lr'gliI-eriiirrfiig diodes.
`
`eludes an array of six identical photodetectors arranged
`symmetrically in a hexagonal configuration surround-
`ing two pairs of red (peak emission wavelength, 660
`nm) and infrared (peak emission wavelength, 930nm)
`light-emitting diodes (LEDS)
`In another related
`study, we showed that by locally heating the skin under
`the sensor to a temperature above 40°C, it is possible to
`achieve a four- to fivefold increase in the magnitude of
`the pulsatile component detected from the forearm, and
`thus significantly improve the detection reliability ofthe
`reflectance photoplethysmograms
`The new optical
`reflectance sensor designed for this study combines the
`two features described above.
`
`SEIISIIH DESIGN
`
`reflectance sensor
`The teniperature-controlled optical
`used in this study is shown in Figure 1. The major fea-
`ture of the optical layout design is the multiple photo-
`diode array, which is arranged concentric with the
`LEDs. This arrangement maximizes the amount of
`backscattered light that is detected by the sensor. The
`technical details related to the design and geometric
`
`8 joirrnal o_,I"Clr'm'ml Mnm’mrr'n_Q Vol 7 Nu Ijanmiry 1991'
`
`company, are better reliability in critical care situations
`such as peripheral circulatory shutdown, less interfer-
`ence from ambient light, and better accuracy because
`measurement from the forehead is relatively unsuscep-
`tible to motion artifacts.
`
`there are no commercially available re-
`Currently,
`flectance pulse oximeters for monitoring SaO2 from lo-
`cations other than the forehead. Therefore. the objective
`of this work was to investigate the feasibility of moni-
`toring S303 with a skin reflectance pulse oximeter from
`two alternative and convenient locations on the body:
`the ventral side ofthe forearm and the dorsal side ofthe
`
`calf. Besides extending the clinical application of pulse
`oximetry, it appears also that reflectance pulse oximetry
`from peripheral tissues may have potential advantage in
`the assessment of local blood oxygenation after skin
`transplantation and regeneration Following microvascu—
`lat surgery.
`In this article, we describe preliminary in vivo evalua-
`tion ofa new optical reflectance sensor for noninvasive
`monitoring of SaO3 with a modified commercial trans»-
`mittance pulse oximeter. We present the experimental
`evaluation of this sensor in a group of 10 healthy adult
`volunteers and compare 8302 measured with the reflec-
`tance pulse oximeter sensor, SpO3(r), with SaO3 mea-
`sured noninvasively from the finger by a standard trans-
`mittance pulse oximeter sensor. SpO3(t).
`
`IIEFLEBTAHBE PULSE I|X|ME'l'llY
`
`The principle of reflectance, or backscatter, pulse ox-
`imetry is generally similar to that of transmittance pulse
`oximetry. Both techniques are based on the change in
`light absorption oftissue caused by the pulsating arterial
`blood during the cardiac cycle. The pulsating arterioles
`in the vascular bed, by expanding and relaxing, mod-
`ulate the amount of light absorbed by the tissue. This
`rhythmic change produces characteristic photoplethys—
`Inographic waveforms, two of which are used to mea-
`sure SaO2 noninvasively.
`Recently, we showed that accurate noninvasive mea-
`surements of SaO2 from the forehead can be made with
`an unheated reflectance pulse oximeter sensor
`The
`major practical limitation of reflectance pulse oximetry
`is the comparatively low-level photoplethysmograms
`recorded from low-density vascular areas of the skin.
`Therefore,
`the feasibility of reflectance pulse oximetry
`depends on the ability to design an optical reflectance
`sensor that can reliably detect sufficiently strong reflec-
`tance photoplethysmograms from various locations on
`the skin.
`
`In order to partially overcome this limitation, we
`have developed an optical
`reflectance sensor that
`in-
`
`

`
`Mriitieisoia and MrCi‘mi: Sim! Rt:flt‘Ca'rI.|h‘t‘ Pulse Oacfim-try
`
`9
`
`configuration ofthe optical components were described
`rccentiy by Mendelson et al
`The heater consists of a ring-shaped (dimensions:
`30-min outside diameter;
`"l5-mm inside diameter)
`thermofoil resistive heating element (Ocean State Ther-
`motics, Smithfleld, RI). The thermofoil heater was
`mounted between the surface of the optically clear
`epoxy, which was tised to seal the optical components
`ofthe reflectance sensor, and a thin (0.005 mm) match-
`ing brass ring. which facilitates better thermal condL1c—
`tion to the skin. A miniature (dimensions: 2 X 5
`X I mm) solid—state ternperature transducer (AD 590,
`Analog Devices, Wilmington, MA) was mounted on
`the outer surface of the brass ring with the thermally
`sensitive surface facing the skin. The entire sensor as-
`sembly was potted in room-temperature vulcanizing
`silicorie rubber to minimize heat losses to the sur1'ot1nd-
`
`ing environment. The assembled sensor weighs approx-
`imately 65 g. The sensor measures approximately 38
`mm in diameter and is 15 mm thick. The heater assem-
`
`bly was separately interfaced to a temperature controller
`that was used to vary the temperature of the skin be-
`tween 35 and 45°C in ] : 0. 1°C steps.
`
`SUBJECTS Mill METHODS
`
`Dam Arqm'si(ien
`
`Each of the two heated optical reflectance sensors were
`separately interfaced to a temperature controller and a
`commercially available ACCUSAT (Datascope Corp,
`Paramus, NJ) pulse oximeter [3].
`Two of the three ACCUSAT pulse oximeters were
`modified to function as reflectance pulse oxiineters. The
`modification, which was described in a separate study
`[1], included the adjustment ofthe red and infrared LED
`intensities in the reflectance sensors so that the reflec-
`
`tance photoplethysmograms were approximately equal
`to transmittance photoplethysmograms measured by a
`standard transmittance sensor from an average size adult
`finger tip.
`The third ACCUSAT transmittance pulse oximeter
`was used as a reference to measure SpO3(t) from the
`finger tip. The specified accuracy of this transmittance
`pulse oximeter is $2.00/o and t4.0°/1 for 5210; values
`ranging between 70 and 100% and 60 and 70%, respec-
`tively
`The three pulse oximeters were adapted to
`provide continuous digital rcadouts of the AC and DC
`components of the red and infrared photoplethysrno-
`grams.
`
`Readings from each ofthe three pulse oximeters were
`acquired every 2 seconds through a standard RS—232C
`
`serial port interface using an AT&T 6300 personal com-
`puter. The conversions of the reflectance redfinfrared
`(IUIR) ratios measured by the two reflectance pulse ox-
`imeters to SpO3(r) were performed by using the cali-
`bration algorithm obtained in a previous calibration
`study in which measurements were made with a similar
`nonheated sensor from the forehead [1].
`
`In Vivo Study
`
`The ability to measure SpO2(r) from the forearm and
`calf was investigated in vivo during progressive steady-
`state hypoxia in humans.
`Measurements were acquired from 10 healthy non-
`smoking male adult volunteers ofdifferent ages and skin
`pigmentations. The study was performed in compliance
`with the University of Massachusetts Medical Center’s
`review guidelines on human experimentation. Each
`volunteer was informed of the complete procedure as
`well as the possible risks associated with breathing hy-
`poxic gas levels. Each volunteer received monetary
`compensation for participation in this study. The sub-
`ject distribution included 1 East Indian, 3 Asians, and 2
`darkly tanned and 4 lightly tanned Caucasians. Their
`ages ranged from 22 to 37 years old {mean 1 SD, 27.5
`: 4.9 years). Measured blood hematocrits were in the
`range of 40 to 50.5% (mean 1 SD, 45.7 1 3.2%).
`All instruments were allowed to warm up for at least
`30 minutes before the study. The transmittance sensor
`of the pulse oximetcr was attached to the index finger.
`The rcfiectance sensors were attached to the ventral side
`
`of the forearm and the dorsal side of the calf by using a
`double—sided transparent adhesive ring. In cases where
`an abundance of hair prevented intimate contact be-
`tween the sensors and the skin,
`the contact was im-
`
`proved by loosely wrapping the sensor and the limb
`with an elastic strap. The temperature of each reflec-
`tance sensor was set to 40°C and remained unchanged
`throughout the entire study.
`A standard lead—l electrocardiogram and end-tidal
`carbon dioxide levels were continuously monitored by
`a Hewlett-Packard '/8345A patient monitor (Hewlett-
`Packard, Andover, MA). Each subject was placed in a
`supine position. A face mask was tightly fitted over the
`subject’s nose and mouth, and the subject was instructed
`to breathe spontaneously while we administered differ-
`ent gas mixtures of nitrogen and oxygen. The inspired
`gas mixture was supplied by a modified Heidbrink anes-
`thesia machine (Ohio Medical Products, Madison, WI).
`The breathing circuit of the anesthesia machine was
`equipped with a carbon dioxide scrubber (soda lime).
`The inspired oxygen concentration was adjusted be-
`tween 12 and 100% and was monitored continuously
`
`

`
`]0 jonrmrl ofCh'm’m! Monr’rarr'ng Vol’ 7 Na Ifinnmry I991
`
`throughout the study with an IL 408 (Instrumentation
`Laboratories, Lexington. MA) oxygen monitor, which
`was inserted in the inspiratory limb of the breathing
`circuit.
`
`Steady-state hypoxia was gradually induced by low-
`ering the inspired fraction of oxygen in the breathing
`gas mixture. Initially,
`the inspired oxygen concentra-
`tion was changed in step decrements. each step pro-
`ducing approximately a 5% decrease in SpO2(t) as
`determined from the display of the ACCUSAT
`transmittance pulse oximeter. The inspired oxygen was
`m_aintained at each level for at least 3 minutes until the
`
`pulse oximeter readings reached a steady level (i.e..
`SaO2 fluctuations ofless than 1-3%). When the inspired
`oxygen level reached 12%,
`the process was reversed.
`Thereafter, the inspired oxygen level was increased in a
`similar stepwise manner to 100%. Data were recorded
`during both desaturation and reoxygenation.
`All subjects tolerated the procedure well without ad-
`verse reactions. None ofthe subjects showed electrocar-
`diographic abnormalities before or after the study. Each
`subject was studied for approximately 1 hour.
`
`Data Analysis
`
`To avoid operator biases, the data from each pulse ox-
`imeter were acquired automatically by the computer
`and later subjected to the same statistical tests.
`For each step change in inspired oxygen, readings
`from the three pulse oximeters were averaged consecu-
`tively over a period of 20 seconds. Averaged readings
`from the 10 subjects were pooled and 3 least—squarcs
`linear regression analysis was performed. Student's r test
`determined the significance of each correlation; p <
`0.001 was considered significant.
`Although the correlation coefficient of the linear re-
`gression (r) provides a measure of association between
`the SPOg(l') and SpO2(t) measurements, it does not pro-
`vide an accurate measure ofagreement between the two
`variables. Therefore, the measurement accuracy was es-
`timated on the basis ofthe mean and standard deviations
`
`of the difference between the readings from the trans-
`mittance and reflectance pulse oximeters. The mean of
`the difference between the pulse oximeter measure-
`ments, which is often referred to as the bias, was used to
`
`assess whether there was a systematic over— or underes-
`timation of one method compared with the other. The
`standard deviation of-the bias, which is often referred to
`as the precision. represents the variability or random
`error. Finally, we computed the mean errors and stan-
`dard deviations of each measurement. The mean error
`
`is defined as the absolute bias divided by the corre-
`sponding SpO3(t) values.
`
`
`
`R/IRRzrmcrmcsRATIO E‘-":"(DRJ
`
`+—s-—
`
`FORLRM
`Y = 1.02K - 0.05
`CAL?
`Y = 0.373 + 0.04
`
`0. 4
`
`-
`
`D. 8
`
`1. 2
`
`1. 5
`
`R/IR Tannsura-mines ruvuo
`
`Fig 2. Cornpmfson afred/irrflnred (RI IR) mrfos measured by {in
`nmdffied refiernmte pnise oxiinrrrr (y axis) and tin: srrrnnhrri trans-
`nn’rmm'e pnisr oxinlerer (x :1.\'fs) during prqgrrssiw steady-smrr
`liypo.\'r'rr in 10 iieriifiry sirigiecrs. The snhri iine J'£’pl'£’$'£.’Hl'S the lies!-
`‘fitted ifnmr regrrssfrnr .'nrr_,*'or n':t-fn'earrir measnrrrneu.'s. The (inn-
`leen line f'£'pf‘£*S[’lIi‘S the best-fiffeti linear regression linefor the rail"
`nieasnremem's.
`
`RESULTS
`
`Normalized IUIR ratios and SpO2(r) values measured
`by the reflectance pulse oxinieters from the forearm and
`calf of the 10 subjects were compared with the nor-
`malized RIIR ratios and SpO2(t) values measured simul-
`taneously by the transmittance pulse oximeter from the
`finger. A total oF9'l and 93 pairs ofdata points measured
`simultaneously from the Forearm and calf, respectively.
`were used in the regression analysis, which provided the
`estimated slopes and intercepts of the linear regression
`lines. Each pair of data points represents a different hy-
`poxic levei.
`Regression analysis of the normalized RHR ratios
`measured from the reflectance pulse oximeters from the
`forehrm and calf (y axis) versus the normalized RHR
`ratios measured simultaneously by the tmnsniittancc
`pulse oximeter from the finger tip (x axis) is shown in
`Figure 2. The equations for the best—fitted linear regres-
`sion lines were y = — 0.05 + 1.02): (r = 0.94. SEE =
`0.08, p d 0.001) for the Forearm and y -= 0.04 + [).87x
`(r = 0.88, SEE = 0.11. p < 0.001) for the calf.
`A comparison of SpO3(r) readings from the reflec-
`tance pulse oximeter (y axis) and SpO2(t) readings mea-
`
`

`
`t\rlt’urieisott ami .r".«irGr'nn: Skin Reflectance Pulse Oxt‘metry
`
`11
`
`UD C3
`
`CD CD
`
`nasnacrauceS902(a)
`
`FORIRRH
`3 - 1.09: — 7.06
`CRLT
`Y I 0.93x + T.TB
`
`80
`
`90
`
`100
`
`an
`
`rnansurrrauca SPO2 (s)
`
`1-nnusurnmucn 51:02 (at)
`
`Fig 3. Comparison afpereent arteriai lretaagiohitt oxygen satm'a-
`tion (SpO2) measurements abtafm-dfitom the modified rtflettrmre
`pulse oximeter ()1 axis) and SpO;» vaittes measnreri hy a standard
`transmittamte pttise aximeter {x axis) dtrritig progressive steady-
`state hypoxia in 10 itealthy stthjetts. The solid line represents the
`hrst-fitted linear t'egressian line for the forearm ttteasttremettts. The
`braieen line represents the best-fitted linear regression line fin the
`wit measurements.
`
`Fig 5. Mean ritflerehces between arterial. hetttaglohhi oxygen sat-
`uration (S1302) measured from the caifhy the tttaritfied reflectattre
`pulse oxfttteter rmri the standard transmittance pulse aximeter mea-
`sitremettts fiam the finger tip.
`
`Statistical Analysis ofArterr'ai Oxygen Saturation (SaO2) Levels
`Measured flom the Forearm and Cal)‘ by the Modified Reflectante
`Pulse Oxittteters
`
`Location!
`‘/a S202
`
`Forearm
`90-100
`80~89
`70-79
`
`Calf
`90-100
`80-89
`70-79
`
`No. of
`Data Points
`
`Mean Value (SD)
`
`Difference
`
`% Error
`
`12
`
`43
`33
`17
`
`2.47 (1.66)
`2.35 (2.45)
`2.42 (1.20)
`
`1.57 (4.00)
`2.22 (4.00)
`1.95 (2.42)
`
`3.36 (3.06)
`3.45 (4.12)
`2.97 (2.75)
`
`sured simultaneously from the transmittance pulse ox-
`irneter (x axis) is shown in Figure 3. The equations for
`the best—f1tted linear regression lines were y = — 7.06
`+ 1.09): (r = 0.95, SEE = 2.62, p < 0.001) for the
`forearm and y = 7.78 + 0.93): (r = 0.88, SEE = 3.73,
`p < 0.001) for the calf.
`Figures 4 and 5 show the percent differences between
`SpO2(r) and SpO2(t), that is, SpO2(r) - SpO2(t). ob-
`tained from the forearm and calf data plotted in Figure
`3, respectively. The corresponding means and standard
`deviations of the differences and errors for the forearm
`and calf measurements are summarized in the Table.
`
`DIFFERENCES
`
`Q0
`
`IUU
`
`TRANSMITTANCE S1302 Ht)
`
`Fig 4. Meat: dt_'fli?t'entes between arterial hemoglobin oxygen sat-
`ttratiott (SFIO2) ttteautredfrom the fisrearm by the rttadtfied refle€-
`tanee pulse oximeter and the startdarri trattstrtittanre pulse oximeter
`rm-asuremeuts float the finger tip.
`
`

`
`I2 _,lrmrm1l o_,fClim'rrll Arlaiiitiiriiig Vol 7 No 1' _,l:1um1i'y 1991
`
`Data were summarized for three different ranges of
`SpO3(t) values between 70 and 100%.
`
`IIIISIIIJSSIIIII
`
`Commercially available transmittance sensors can be
`used on only a limited number of peripheral locations of
`the body. Brinkman and Zijlstra [4] and Cohen and
`Wadsworth [5] showed that instead of tissue transil-
`lumination, noninvasive monitoring of SaO2 can be
`performed based on
`skin
`reflectance
`spectropho-
`tometry. More recently, we described an improved
`optical reflectance sensor that was used for measuring
`SaO2 from the forehead with a modified commercial
`
`transmittance pulse oximeter
`Measuring large reflectance photoplethysmograms
`from sparsely vascularized areas ofthe skin is challeng-
`ing. Differences in capillary densities between various
`locations on the body are known to affect the magnitude
`and quality of the reflected photoplethysmograms. For
`example, estimated average capillary density of the hu-
`man forehead is approximately 127 to 149 loopsr"mm2,
`whereas the capillary densities of the forearm and calf
`are approximately 35 to 51 and 41 loopsfmmz, respec-
`tively [6,7]. Furthermore, the frontal bone of the fore»
`head provides a highly reflective surface that signifi-
`cantly increases the amount of light detected by the
`reflectance sensor. Therefore,
`reflected photoplethys-
`mograms recorded from the forehead are normally
`larger than those recorded from the forearm and calf.
`Local skin heating could be used as a practical method
`for improving the signal-to-noise ratio of the reflected
`photoplethysmograms from the forearm or calf areas
`and thus reduce the measurement errors in reflectance
`
`pulse oximetry.
`The approach presented in this article demonstrated
`that $302 can be estimated by using a heated skin
`reflectance sensor from the forearm and calf over a rela-
`
`tively wide range of S303 values. This technique may
`provide a clinically acceptable alternative to currently
`available transmittance pulse oxirneters. In a previous
`study [2}, we found that the ability to measure accurate
`SaO2 values with a reflectance skin oximeter is indepen-
`dent of the exact skin temperature. We noticed, how-
`ever,
`that a minimum skin temperature of approxi-
`mately 40°C is generally sufficient to detect adequately
`stable photoplethysmograms. Furthermore, our experi-
`ence in healthy adults also has shown that at this skin
`temperature, the heated sensor can remain in the same
`location without any apparent skin damage.
`Note that despite the proven advantage of local skin
`heating to increase skin blood flow.
`reflected photo-
`plethysmograms recorded from the forearm and the calf
`are considerably weaker than those recorded from the
`
`the mean errors for the SpO3(r)
`forehead. Therefore,
`measurements from the forearm and calfare higher than
`the corresponding errors for similar SpOg(r) measure-
`ments made with an unheated reflectance sensor from
`
`the forehead. For comparison, relative to 5:103 mea-
`sured with a noninvasive transmittance pulse oximeter,
`the SEE for SpO2(r) measurements obtained from the
`forehead using a similar unheated optical
`reflectanee
`sensor were 1.82% [1]. The SEE obtained in this study
`using the heated reflectance sensor were 2.62% for the
`forearm and 3.73% for the calf measurements. Despite
`those differences, it is apparent that the degree ofcorre-
`lation obtained i11 this preliminary study is encouraging
`and in selected clinical applications may be acceptable.
`We conclude that reflectance pulse oximetry from the
`forearm and calf may provide a possible alternative to
`conventional transmittance pulse oximetry and retice-
`tance pulse oximetry from the forehead. Further stud-
`ies, however, are needed in order to compare our
`reflectance pulse oximeter against SaO2 measurements
`obtained directly from arterial blood samples. Addi-
`tional work to investigate the source of variability in
`reflectance pulse oximetry is i11 progress.
`
`Financial support for this study was provided in part by the
`Datascope Corporation and NIH Grant R15 GM36l l l-UIAI.
`
`The authors would like to acknowledge the clinical assistance
`of Albert Shahnarian, PhD, Gary W. Wclch MD, PhD, and
`Robert M. Giasi, MD, Department of Anesthesiology, Uni-
`versity of Massachusetts Medical Center, Worcester, MA.
`We also thank Paul A. Nigroni, Datascope Corporation.
`Paramus, NJ, and Kevin Hines, Semiconductor Division,
`Analog Devices, Wilmington, MA, for technical assistance.
`The skillful art work by Yi Wang is also greatly appreciated.
`
`REFERENCES
`
`. Mendelson Y, Kent _]C, Yocmn BL, Birle M]. Design and
`evaluation of a new reflectance pulse oximeter sensor.
`Biomed lnstrum Techno] 1988;22(4):l67—]73
`

This document is available on Docket Alarm but you must sign up to view it.


Or .

Accessing this document will incur an additional charge of $.

After purchase, you can access this document again without charge.

Accept $ Charge
throbber

Still Working On It

This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.

Give it another minute or two to complete, and then try the refresh button.

throbber

A few More Minutes ... Still Working

It can take up to 5 minutes for us to download a document if the court servers are running slowly.

Thank you for your continued patience.

This document could not be displayed.

We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.

Your account does not support viewing this document.

You need a Paid Account to view this document. Click here to change your account type.

Your account does not support viewing this document.

Set your membership status to view this document.

With a Docket Alarm membership, you'll get a whole lot more, including:

  • Up-to-date information for this case.
  • Email alerts whenever there is an update.
  • Full text search for other cases.
  • Get email alerts whenever a new case matches your search.

Become a Member

One Moment Please

The filing “” is large (MB) and is being downloaded.

Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.

Your document is on its way!

If you do not receive the document in five minutes, contact support at support@docketalarm.com.

Sealed Document

We are unable to display this document, it may be under a court ordered seal.

If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.


Access Government Site

We are redirecting you
to a mobile optimized page.





Document Unreadable or Corrupt

Refresh this Document
Go to the Docket

We are unable to display this document.

Refresh this Document
Go to the Docket