1.0.1_ECG new specification analysis

Introduction
This document is about how to extract real-time ECG data as stated in new ECG
specification (see Annex for more details).
The current version of Onyx is only configured to perform and collect data related to
resting ECG measurement. These data are extracted from a XML file and saved in
Onyx database, along with this file and a resting-ECG PDF report.
According to the new specification document, information about real-time ECG
measurement is enclosed in <FullDisclosure> node in the same XML file.
1. <FullDisclosure> node description:
Figure 1. ECG resulting XML file screenshot
The following table describes in detail each node in <FullDisclosure> section. In
description column, section refers to a node that may contain either child nodes or
fields and field means a leaf node.
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Tag
Description
Attributes
Range
Required
Instance
FullDisclosure
This section contains the full
disclosure data
This fields contains the
number of acquired leads
This field contains the number
of samples per second
One sample increment meets
to this number of microvolts
This field contains all leads
separated by comma
All full-disclosure samples are
separated by comma in the
following order:
Sample-1 Lead-1, Sample-1
Lead-2…
Sample1
Lead
NumberOfChannels,
Sample-2 Lead-1. Sample-2
Lead-2…Sample2
Lead
NumberOfChannels
None
---
No
Single
None
---
Yes
Single
Units=
[Hz]
Units=
[uVperLsb]
None
[100,200,500]
Yes
Single
[5.0]
Yes
Single
---
Yes
Single
None
---
Yes
Single
Yes
Single
Yes
Single
No
Multiple
No
Multiple
Yes
Single
Yes
Single
NumberOfChannels
SampleRate
Resolution
LeadOrder
FullDisclosureData
SampleCount
EventList
Event
Time
Minute
Second
This field contains the number None
--of samples that the tag
FullDisclosureData contains
This section contains the None
--events, detected while full
disclosure was active
This field contains the event None
--name
This section contains the time None
--of the event
This field contains the minute None
--when the event occurred
This field contains the second None
--when the event occurred
Table 1. XML Data Export: Real-time ECG XML tags1
For CARTaGENE study, only real-time ECG graph and interpretation are relevant,
so other data enclosed in <FullDisclosure> won’t be parsed.
Fortunately, ECG software includes a functionality that does exactly what we need.
By adding specific configuration codes (code for real-time ECG memorization
(EGMO) and code for stress test (ERG2)), real-time ECG graph will be generated as a
PDF document and real-time interpretation will be printed in resting ECG PDF
report.
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CASE, CardioSoft V6 XML Export Reference Manual 2025486-001
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Steps to generate real-time ECG graph from the software:
1. Click on “start real-time ECG button”:
2. After two minutes, click on “Stop real-time ECG/post-test review”:
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3. Go to “real-time ECG tab” and click on “Print” icon:
4. Choose which derivation to include in the PDF and then click on “Print”:
It is possible to save selected option for next sessions by clicking on “Save” button.
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The resulting real-time ECG PDF looks like:
And the interpretation is included in resting ECG PDF report:
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For the moment, it’s the easiest and the less expensive solution that we found to
implement the new specification. However, it will be more interesting if we can
automate the PDF generation, without requiring manual clicks from the nurses (only
two clicks).
2. Implementation:
To implement this, Onyx would be modified in order to:
 Add a new output for ECG measurement and modify initialization files;
 Add validation to see whether the real-time ECG measurement was taken and
PDF document generated or not, and save the PDF to Onyx database;
 Define a new export destination (more details about export destinations will
follow), which will contain real-time ECG graph and resting ECG report, that
are generated directly from ECG software, as a node in an XML file;
 When exporting data from Onyx, put PDF documents in the according export
destination.
Once at CARTaGENE, use available tools (free converters or home-developed ones,
Opal, etc.) to regenerate the real-time ECG PDF and resting ECG PDF, and make them
available for specialists.
Onyx features includes defining several export destinations via a configuration file
named “WEB-INF/config/export-destinations.xml”:
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Figure 2. export-destinations.xml file screenshot
For instance, in the case of CARTaGENE, PDF consent forms of completed and closed
interviews are exported to a folder with the same name. Besides cancelled
interviews related information, are exported to appointment-unit folder.
It is then possible to add a new export destination called for example: “CARTaGENE
cardiologist” or “ECG specialist” where to put the generated PDF files, converted to
XML nodes.
 Does modifying Onyx classes to collect real-time ECG measurement has
further implications? (for old interviews for example)
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Annex:
Nouvelles spécifications de la mesure de la bande de rythme cardiaque
Input :
Idem de ce qui est déjà configuré dans la version actuelle d’onyx
Output :
Tous les paramètres du module ECG actuel mais en plus des données d’interprétation d’ECG temps
réel (ECG temps réel permet d’avoir le rythme cardiaque de plusieurs minutes au lieu de 10
secondes) et les tracés des bandes de rythme. Ces données devraient être sauvegardées dans un
fichier PDF et XML. Il est possible d’avoir un échantillon d’ECG de 10 secondes d’où les mesures du
rythme cardiaque sont calculées et les tracés sont sauvegardés. En ce qui concerne les données de
l’option ECG temps réel, CardioSoft ne permet pas d’avoir les tracés dans un fichier PDF, mais il les
sauvegardes dans le fichier XML.
Procédure :
La fonction ECG temps réel nécessite des codes spécifiques pour chaque ECG
Étape d’enregistrement des données :
1. Acquisition de l’ECG (étape pour l’acquisition des données de 10 secondes)
2.
Démarrage temps réel (étape pour l’acquisition des données de 1-2 minutes)
3. Revue post-épreuve (étape pour sauvegarder les données de 10 secondes en PDF
et l’ECG temps réel dans un fichier XML). Le fichier XML contient également les
données d’ECG de 10 secondes.
Note : Les tracés d’ECG de temps réel sont codés dans un nœud appelé « FullDisclosure »
dans le fichier XML; malheureusement, la compagnie ne fournie pas d’application pour
régénérer ces tracés.
Une fois que les fichiers PDF et XML sont rendus dans les serveurs de CaG (à partir des
tous les serveurs des différents sites, un fichier PDF contenant les données du rythme
cardiaque (résumé des tracés de 10 secondes, l’analyse d’ECG temps réel et son tracé de 1
à 3 minutes) de chaque participant doit être reproduit dans un fichier PDF pour le mettre
à la disposition d’un spécialiste pour qu’il puisse le consulter.
La stratégie pour mettre les fichiers PDF des participants à la disposition du spécialiste est à la
discrétion de Serge.
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