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先天性心疾患ソフトウエアの選定理由書
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医療用具購入選定委員会 御中
      先天性心疾患の心カテ及びデータ管理ソフトウエア製品           
   始めに、本年度、ご購入頂きたい製品「ペドカス7」の見積もりおよびカタログを添付する。
   現在まで、我々の施設では、先天性心疾患等の診断および治療を、専用のソフトウエアを用いて
   行ってきていなかった。今回、当該ソフトウエアの専門メーカである 米国 サイエンティフィック 
   ソフトウエア ソルーション社 の資料の精査、かつ当該ソフトウエアのデモ版を検討した結果、
   より専門性向上を図ること、院内関係者および地域連携の医療機関とのより高度な病診連携を
   進める為に、購入申請をすることとした。

   これは、先天性心疾患および正常心臓の血行動態データを、マニュアルおよび自動入力して演算
   する最先端ソフトウエアであり、演算後の修正、また先天性心疾患固有の数値判断に対しては、
   他の施設の経験値などが参照でき、極めて正確にデータをまとめることができ、結果として、極めて
   正確な診断ができることを助ける。

   
このソフトウエアを利用することにより、当施設は次の利点を享受できる。
   1.現在、市販されているソフトウエアの中では、血行動態の演算は一番高速である。
   2.先天性心疾患部分(ダイアグラム図、図内演算)は、市販の中で一番進歩している。
     我々が使用しているカテラボのポリグラフ及び撮像装置からのデータ、イメージ、テクスト文を
     採集できる。

 
  3.このソフトウエアから作成されたデータベースから、検索ができる。このことから、医師は、最初
     からの診断、治療の経過をいつでも参照でき、いつも結果を参照しながら、最善の治療を実施
     できる。
更に多くの患者のデータを参照することにより、比較することにより、より良い治療を施す
     ことが可能である。
   4.このソフトウエアにより、当該施設は、患者の個人情報保護とHIPAAコンプライアンスの
     ガイドラインを保証できる。従って、データの最新更新、検索、保険請求等に威力を発揮する。
 
 5.このデータは
、他の施設からも利用でき、必要ならば、患者の個人情報を見えなく設定することが
     できる。また、患者の複雑なデータ(他の疾患も含む場合)もそれぞれの専門家に、電子的に
     送信するころにより、すばやくより良い診断を頂き、その担当医がより良い治療を実施できるよう
     になる。
     
   これは、極めて革新的な仕様であり、できるだけ早く利用したいと願っている。これは、先天性心疾患
   をより正確に診断する手法を提供してくれる。そしてこのソフトウエアは、サイトライセンスを購入する
   ものであり、中央記憶装置付きサーバーパソコンはもちろん、すべての循環器関係のパソコンに
   インストールする。従って、関係部門からすべて、このデータに、個人情報入手段階で分けられるが、
   アクセス可能である。更にご質問があればお寄せ頂きたい。

   このリクエストに対して、貴殿のご援助とご配慮を感謝する。

   循環器科医 部長  XXX より

注;本文は、実際米国での、ある医師のご好意により提供されたものを簡約した。
Medical Teknika Medical Teknika Medical Teknika Medical Teknika Medical Teknika
Medical Teknika Medical Teknika Medical Teknika Medical Teknika Medical Teknika
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非観血血圧付き心電図ホルタの文献   負荷心電図検査の医学文献    エアロビックの効果   心電・血圧ホルタ記録器

  ブルーツース    デュナ   デュナの実例     遠隔同時表示    ラブテック製品    Labtech products
画像例は下記をご参照願います。

http://www.din.or.jp/~meditekn/medi_hp/
上記の一番下部に解説付きで、応用例を掲載

http://www.din.or.jp/~meditekn/medi_hp/duna/
http://www.din.or.jp/~meditekn/medi_hp/masterblue/
ラブテック社製マスターステップの使用例掲載

http://www.din.or.jp/~meditekn/medi_hp/duna2/
医大検査室での使用例、画面例及び記録例も掲載

http://www.din.or.jp/~meditekn/medi_hp/remoterunning12ecgs/
ソニーの超小型パソコンを利用したランニング仕様の用途例

http://www.din.or.jp/~meditekn/medi_hp/aerobicacc/
米国循環器学会で推奨された心臓病患者への心臓リハビリ法としての
エアロビックの効能についての発表

http://www.din.or.jp/~meditekn/medi_hp/gtec/
出力のRR間隔データの解析例、これは別売のソフトウエアとなります。

http://www.din.or.jp/~meditekn/medi_hp/stressdata/
負荷試験での重要な医学的指標、米国心臓病学会のスタンダードとして発布

http://www.din.or.jp/~meditekn/medi_hp/labtechholter/
ラブテックパソコンホルタのご紹介

http://www.din.or.jp/~meditekn/medi_hp/labtech1/
ラブテック社製品としてのパソコン式の利用価値 等を掲載しております。

PCの機能が向上し、Descrete Wavelet 手法が、お求めやすい低価格で

実現し、心房のP波を自動検出できるようになりました、

心房細動の自動解析能をお試し賜われれば幸いです


Labtech社は、当社独自の方法による

P波自動検出と心房細動自動解析手法

T Wave Alternans 解析手法を開発し、当社ホルターに搭載。


VectraCardiology,Heart Rate Variability ,TWA オルタナンス
Turbulence、3D可変表示、Spectral Analysis等が装備


ケアテイカ

非観血相対血圧・連続・ポータブル・ウエアラブル・一拍毎解析出力付き

httpswww.ncbi.nlm.nih.govpmcarticlesPMC5361833

 

BMC Anesthesiol. 2017; 17: 48.

Published online 2017 Mar 21. doi: 10.1186/s12871-017-0337-z

PMCID: PMC5361833

PMID: 28327093

Continuous Non-invasive finger cuff CareTaker® comparable to invasive intra-arterial pressure in patients undergoing major intra-abdominal surgery

Irwin Gratz,1 Edward Deal,1 Francis Spitz,1 Martin Baruch,2 I. Elaine Allen,3 Julia E. Seaman,4 Erin Pukenas,1 and Smith Jean1

Author information Article notes Copyright and License information Disclaimer

This article has been cited by other articles in PMC.

 

Associated Data

Data Availability Statement

The datasets generated during and analysed for the current study are available from the corresponding author on reasonable request.

 

Abstract

Background

Despite increased interest in non-invasive arterial pressure monitoring, the majority of commercially available technologies have failed to satisfy the limits established for the validation of automatic arterial pressure monitoring by the Association for the Advancement of Medical Instrumentation (AAMI). According to the ANSI/AAMI/ISO 81060–2:2013 standards, the group-average accuracy and precision are defined as acceptable if bias is not greater than 5 mmHg and standard deviation is not greater than 8 mmHg. In this study, these standards are used to evaluate the CareTaker® (CT) device, a device measuring continuous non-invasive blood pressure via a pulse contour algorithm called Pulse Decomposition Analysis.

Methods

A convenience sample of 24 patients scheduled for major abdominal surgery were consented to participate in this IRB approved pilot study. Each patient was monitored with a radial arterial catheter and CT using a finger cuff applied to the contralateral thumb. Hemodynamic variables were measured and analyzed from both devices for the first thirty minutes of the surgical procedure including the induction of anesthesia. The mean arterial pressure (MAP), systolic and diastolic blood pressures continuously collected from the arterial catheter and CT were compared. Pearson correlation coefficients were calculated between arterial catheter and CT blood pressure measurements, a Bland-Altman analysis, and polar and 4Q plots were created.

Results

The correlation of systolic, diastolic, and mean arterial pressures were 0.92, 0.86, 0.91, respectively (p<0.0001 for all the comparisons). The Bland-Altman comparison yielded a bias (as measured by overall mean difference) of −0.57, −2.52, 1.01 mmHg for systolic, diastolic, and mean arterial pressures, respectively with a standard deviation of 7.34, 6.47, 5.33 mmHg for systolic, diastolic, and mean arterial pressures, respectively (p<0.001 for all comparisons). The polar plot indicates little bias between the two methods (90%/95% CI at 31.5°/52°, respectively, overall bias=1.5°) with only a small percentage of points outside these lines. The 4Q plot indicates good concordance and no bias between the methods.

Conclusions

In this study, blood pressure measured using the non-invasive CT device was shown to correlate well with the arterial catheter measurements. Larger studies are needed to confirm these results in more varied settings. Most patients exhibited very good agreement between methods. Results were well within the limits established for the validation of automatic arterial pressure monitoring by the AAMI.

Keywords: Non-Invasive, CareTaker, Central blood pressure, Finger cuff, Intra-Arterial pressure


Tensiomed 社 Arteriograph 24 血管脈波検査装置

ご注意:中心血圧と関連機能は検証が必要です、

Central blood pressure: current evidence

and clinical importance

Carmel M. McEniery1*, John R. Cockcroft2, Mary J. Roman3,

Stanley S. Franklin4, and Ian B.Wilkinson1

1Clinical Pharmacology Unit, University of Cambridge, Addenbrookes Hospital, Box 110, Cambridge CB22QQ, UK; 2Department of Cardiology,Wales Heart Research Institute, Cardiff

CF14 4XN, UK; 3Division of Cardiology,Weill Cornell Medical College, New York, NY 10021, USA; and 4University of California, UCI School of Medicine, Irvine, CA 92697-4101, USA

Received 29 April 2013; revised 27 November 2013; accepted 17 December 2013; online publish-ahead-of-print 23 January 2014

and central pressure. Therefore, basing treatment decisions on central, rather than brachial pressure, is likely to have important implications

for the future diagnosis and management of hypertension. Such a paradigm shift will, however, require further, direct evidence that selectively

targeting central pressure, brings added benefit, over and above that already provided by brachial artery pressure.

Central pressure Blood pressure Anti-hypertensive treatment Cardiovascular risk

Introduction

The brachial cuff sphygmomanometer was introduced into medical

practice well over 100 years ago, enabling the routine, non-invasive,

measurement of arterial blood pressure. Life insurance companies

were among the first to capitalize on the information provided by

cuff sphygmomanometry, by observing that blood pressure in

largely asymptomatic individuals relates to future cardiovascular

riskobservations that are nowsupported by a wealth of epidemiological

data.1 The most recent Global Burden of Disease report2

identified hypertension as the leading cause of death and disability

worldwide. Moreover, data from over 50 years of randomized controlled

trials clearly demonstrate that lowering brachial pressure,

in hypertensive individuals, substantially reduces cardiovascular

events.1,3 For these reasons, measurement of brachial blood pressure

has become embedded in routine clinical assessment throughout the

developed world, and is one of the most widely accepted surrogate

measures for regulatory bodies.

The major driving force for the continued use of brachial blood

pressure has been its ease of measurement, and the wide variety of

devices available for clinical use. However, we have known for over

half a century that brachial pressure is a poor surrogate for aortic

pressure, which is invariably lower than corresponding brachial

values. Recent evidence suggests that central pressure is also more

strongly related to future cardiovascular events4 7 than brachial

pressure, and responds differently to certain drugs.8,9 Appreciating

this provides an ideal framework for understanding the much publicized

inferiority of atenolol and some other beta-blockers,10 compared

with other drug classes, in the management of essential

hypertension. Although central pressure can now be assessed noninvasively

with the same ease as brachial pressure, clinicians are unlikely

to discard the brachial cuff sphygmomanometer without

robust evidence that cardiovascular risk stratification, and monitoring

response to therapy, are better when based on central rather

than peripheral pressure. Central pressure assessment and accuracy

will also have to be standardized, as it has been for brachial pressure

assessment with oscillometric devices. This review will discuss our

current understanding about central pressure and the evidence

required to bring blood pressure measurement, and cardiovascular

risk assessment into the modern era.

Physiological concepts

Arterial pressure varies continuously over the cardiac cycle, but in

clinical practice only systolic and diastolic pressures are routinely

reported. These are invariably measured in the brachial artery

using cuff sphygmomanometrya practice that has changed little

over the last century. However, the shape of the pressure waveform

* Corresponding author. Tel: +44 1223 336806, Fax: +44 1223 216893, Email: cmm41@cam.ac.uk

Published on behalf of the European Society of Cardiology. All rights reserved. &The Author 2014. For permissions please email: journals.permissions@oup.com

European Heart Journal (2014) 35, 17191725 doi:10.1093/eurheartj/eht565

 

Pressure measured with a cuff and sphygmomanometer in the brachial artery is accepted as an important predictor of future cardiovascular risk.However, systolic pressure varies throughout the arterial tree, such that aortic (central) systolic pressure is actually lower than corresponding brachial values, although this difference is highly variable between individuals. Emerging evidence now suggests that central pressure is better related to future cardiovascular events than is brachial pressure. Moreover, anti-hypertensive drugs can exert differential effects on brachial and central pressure. Therefore, basing treatment decisions on central, rather than brachial pressure, is likely to have important implications for the future diagnosis and management of hypertension. Such a paradigm shift will, however, require further, direct evidence that selectively targeting central pressure, brings added benefit, over and above that already provided by brachial artery pressure.As discussed earlier, a full synthesis of the available evidence concerning

central pressure and the risk of future cardiovascular events is now required. However, it will also be necessary to determine the clinical relevance of differences between brachial and central pressure

for the individual patient, especially given the relatively high correlation between the two. Emerging data support the prognostic superiority of both 24-h ambulatory blood pressure monitoring

(ABPM)79 81 andhomemonitoring81 in comparison with office measurements. Interestingly, a recent study82 demonstrated that 24-h ambulatory cuff pressures were comparable with office central pressure

measurements in the prediction of risk, although the significance of this study awaits confirmation.83 As yet, there are no data comparing the predictive value ofhomemonitoring vs. central pressure in the

prediction of risk. Ultimately, it will be necessary to evaluate the prognostic value of 24-h ambulatory central pressure.With the recent development of ambulatory central pressure systems,84,85 this is now

possible and it may be reasonable to hypothesize that 24-h central, rather than brachial ABPM would be superior in terms of risk prediction.