CENTER-TBI - fourier.neurosurg.cam.ac.ukfourier.neurosurg.cam.ac.uk/wp-content/uploads/2017/09/SOP-Moberg-ICM.pdf · 3 SOP-CENTRE-TBI ICU High Resolution Data collection CENTER-TBI

CENTER-TBI

ICU High Resolution data acquisition

Standard of Procedures (SOP) for ICM+

13 May 2015

Manuel Cabeleira ([email protected])

Dr Peter Smielewski ([email protected])

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SOP-CENTRE-TBI ICU High Resolution Data collection

Table of Contents CENTER-TBI HR ICU Prerequisites ............................................................................. 3

Summary of the HR ICU data flow ................................................................................ 4

Locking and unlocking ICM+ ......................................................................................... 5

Starting a new data collection session .......................................................................... 6

Annotating clinical events ........................................................................................... 10

Creating and uploading Data Snapshots ..................................................................... 11

Terminating the data collection session and uploading the data ................................. 13

Restoring a closed data collection session .................................................................. 16

Manual packaging and uploading of data files ............................................................ 17

Appendix 1: Configuring ICM+ for CENTER-TBI ......................................................... 18

Appendix 2: ICM+ configuration folders and files ........................................................ 23

Appendix 3: Editing ICM+ Projects .............................................................................. 25

Appendix 4: Registering ICM+ .................................................................................... 28

Appendix 5: Configuring the computer’s network interface .......................................... 31

Appendix 6: Description of connectors to selected patient monitors ............................ 35

Appendix 7: Preconfigured users and passwords ....................................................... 37

Appendix 8: Configuring Moberg network ................................................................... 38

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CENTER-TBI HR ICU Prerequisites

1. A laptop (or a PC) with ICM+ mounted by the bed-side for a convenient,

constant, access by the nursing stuff. The positioning is essential to facilitate

thorough clinical events annotation.

2. Where applicable, Moberg CNSMonitor, connected to the ICM+ laptop using a

network interface

3. Active internet connection. If neither Ethernet (cable) or wireless connection is

not available in the ICU a 3G (or 4G) dongle needs to be acquired. The amount of

data transmitted during the data collection session is relatively small ( a few Mb per

data shapshot plus a short text message per each event) so a standard the 3G

network data allowance of 1GB (or even 500MB), in a contract or a pay-as-you-go

connection, should be all that is needed.

4. Appropriate cables for connections between the monitors, Moberg CNS monitor

(if relevant) and the ICM+ latop.

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Summary of the HR ICU data flow

At admission, enrol the patient to the study and acquire GUPI or a temporary Patient

Identifier from the CENTER-TBI intranet. Then:

1. Connect the medical devices to Moberg CNSMonitor, or directly to ICM+ laptop,

whichever applicable, using appropriate cables. Consult appendix ‘Monitors

Connectors’ for more details about which cables to use for each medical device.

2,3. If applicable, start data collection on the CNSMonitor (as per CNSMonitor manual)

and connect it to the ICM+ laptop using a network cable (LAN1 on CNSMonitor).

4 Start ICM+ session Refer to chapter ‘Creation of a new session’ for more

information about how to create a new monitoring session in the CENTER-TBI

context.

During the data collection:

5 Ensure that all the clinical events are annotated as they occur through the Event

Form. Refer to chapter ‘Using the events form’ for more information about how to

use the event form.

6 At 1-4 hours after the start of the data collection session take a data snapshot in

ICM+ and transmit it to Cambridge Refer to chapter ‘Creating Data Snapshots’ for

more information about how to use the snapshot form.

Repeat the same process at 12, 24, 48 and 72 hours.

At the discharge (from the study):

7 Stop the data analysis on ICM+, package the data and send it to the Cambridge

Server. Refer to chapter ‘Terminating a monitoring session and uploading the data’

for more information about how to terminate the data acquisition.

Later, in due course, in Cambridge:

8 The data is verified and uploaded/registered with the INCF central data base

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Locking and unlocking ICM+

ICM+ includes a simple system of user based permissions, which allows it to be used

safely in a clinical environment, also by people with minimal training, ensuring that the

vital data collection process is not inadvertently interrupted or disturbed.

If your ICM+ is correctly configured when the program is run it will automatically

initialize with the default user ‘Nurse’. There are three other users already configured in

ICM+, the Administrator, the Manager and the Operator. The users have been

configured with progressively decreasing operational rights.

The Nurse is the user with the fewest rights in the software, effectively only being able

to insert clinical events, browse the charts and starting new sessions, without any

possibility to disrupt the data collection procedure. Please refer to the ‘How to use the

events form’ for more details. After 3 minutes of inactivity, ICM+ automatically logs in

as a Nurse.

The Administrator is the user that will have full access to the full features of the

application.

The Manager will have the same privileges but will not be able to manage user

accounts.

The Operator will only be capable of starting new Recording sessions with available

profiles, browsing data, inserting clinical information and display configuration.

Login (change users) form is accessible via a button on the tool bar/main menu bar.

When the Login button is pressed, the User login form will appear.

In this form you will find:

1. A button to the Default user and

a button to lock the application so that

nothing but the login button is

accessible.

2. A key pad to insert the

Password for a given user

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3. And a Drop-Down menu to select the user to Login as

Starting a new data collection session

To create a new data acquisition session hit New Patient button.

This will bring up a new form:

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1. You can insert the Patient information manually by using the fields presented in

this form, or if you have already inserted these values on the bed-side monitor

you can just import those using the button ‘Retrieve Demographics from...’ to

use this button you will need to have already selected the profile you will be

using in this data acquisition session. Please note that only the anonymised ID,

age and data of admission and ictus will be transferred to the CENTER-TBI

servers. All the rest of the patient details will only be kept locally and encrypted

inside the file.

2. This is the only field of the Patient Demographics that you will always have to

insert. This is the anonymised ID that you will get from the CENTER-TBI

website. If you don’t have the GUPI (Global Unique Patient Identifier) use a

unique temporary identifier, either supplied by CENTER-TBI or of your own

choosing. Unless you insert this number you will not be able to start a new

session. Please make sure to change the temporary ID to GUPI when it

becomes available. To do that when the session is already in progress you

need to click on the Clinical Notebook tab and then on the Demographics

button.

3. This button will open the folder where you have all the profiles that you can use

for this data acquisition session. The pane just beside this button will provide a

faster way to select the most used profiles.

4. Before starting a new session please ensure that the project is set to CENTER-

TBI.

5. It is very important that you fill in the Date of Birth, Date of Ictus and the Date of

Admission (if possible the hour and minutes too). The Date of Birth does not

need, of course, to be that specific, unless this is a paediatric patient.

If for any chance you need to tweak the profiles, please don’t overwrite the ones

provided. If you don’t have experience with creating or altering profiles please contact

us and we will be happy to help you. These profiles should only be used for the

CENTER-TBI project.

As you are aware there is a minimum set of signals that we will be requiring from every

patient on the study:

ICP waveforms at a sampling rate of at least 100 Hz,

ABP waveforms at a sampling rate of at least 100 Hz,

ECG waveforms at a sampling rate of at least 200 Hz,

SpO2

And if possible also EtCO2 and body temperature

If you are also monitoring other desired modalities (like Licox or Microdialysis) those

can also be added to the profile.

This version of ICM+ is compatible with the profiles of the older versions.

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After the OK button is clicked, the Devices check dialogue is presented.

This dialogue is used to test the communication between the ICM+ and the monitor

(the ‘Test connections’ button). If the test is successful the OK button can be pressed.

This menu can also be used to select the right connection, whether it is a serial

connection (like the one presented in the picture) or an IP address. In the case of a

serial port connection, the button auto allocate ports can be pressed and the

application will search for the right port.

In the case of an IP address, the keyboard button can be pressed and the IP Address

can be inserted.

Just before the session starts, the user is prompted to insert some additional

information about the patient via the Project Specific data dialogue. This form is also

accessible from the Patient Notebook tab but it is highly recommended that it is filled in,

as much as possible and practical to do, at the start of the session.

After this dialogue, ICM+ main display is presented and the session begins recording

automatically.

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If ICM+ shuts down during a recording session the next time it is run, the previous

session is automatically restored, but here the user must first verify that all the signals

are being received correctly in the Monitor button. After this the Start button must be

pressed and the session resumes recording.

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Annotating clinical events

As soon as the acquisition of data starts the main menu tool bar will get minimised and

in its place a small, ‘data acquisition essentials’, tool bar will open, as below.

Clicking the ‘Doctor/Nurse’ button will bring up a form called Event Window.

This form is composed of 9 buttons, each

representing a different event that can occur

during the data acquisition process. This form

is meant to be used by the clinical staff at the

bed-side to document all the listed events as

they occur.

Pressing one of these buttons will open an

Event Confirmation dialog:

This form will present the nurse with a summary of the selected

event and if everything is correct the confirm button needs to be

pressed in order to store the event. This from will allow the user to

edit the time of the occurrence if something prevented the nurse

press the button immediately after the event occurred. It is also

possible to add a comment to the event if needed.

If the event is not confirmed during a given time window it will

automatically close, but this should be avoided as much as

possible as the event will be stored as ‘unconfirmed’.

After the confirmation or cancelation of an event this window will

close and the Event Window will come up again.

The event window can always be closed if, for example, the doctor

needs to browse through the application to browse through the

charts and clinical notes.

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Creating and uploading Data Snapshots

During the data acquisition process, data snapshots should be taken periodically and

uploaded to our servers for confirmation of the validity of the acquired data. These

snapshots should be taken after the first hour of acquisition, again after 12 and 24

hours and at least once every day afterwards. The software will also be configured to

pop up reminder messages at those specific times to make sure the snapshots are

being taken. The Data Snapshot button can be found on the Data tab on the control

panel section.

After the button is pressed the complete data set covering the past 1 our of recording

will be packaged into one compressed format file (HDF5 based format) and the logs of

this process will be shown in a new form (as below). Once finished and the button ok

should be clicked

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After confirming that the file is to be uploaded a new form is presented:

In the dropdown menu called destination, the option CENTER TBI must be selected.

After this the button upload can be pressed and the file is uploaded to our servers.

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Terminating the data collection session and

uploading the data

When the data acquisition process is finished the recording session can be closed

using the Close button present in the ICM+ button. This will initialize a cascade of

forms that will eventually lead to the sealing of the file and subsequent upload of the

generated HDF5 file to Cambridge servers.

Closing a session is different from closing the program. To close the ICM+ application

you need to press the red cross present on the upside corner of the right side of the

screen. If ICM+ is closed (Exited) using this button or if the computer shuts down, the

next time it is run, the recording session will be resumed with the same configurations it

had at the moment of shutdown.

When this button is pressed a dialogue is presented prompting the user to confirm the

closure of the recording session:

After confirming the end of the recording session another dialogue is presented

prompting the user to package the data into a single file:

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After confirming this dialogue the Data Packaging Form is presented, here the user

must confirm the names of the files to be used in the creation of the HDF5 file. The

user should confirm the monitor type used in the unit in the highlighted drop-down

menu and tick the Unidentify checkbox.

After confirming another window will be presented showing all the steps of the creation

of the HDF5 file:

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When the file is successfully created another dialogue will show up prompting the user

to archive, upload or leave that for later. The user should hit the upload button in order

to send the file to the server back in Cambridge to be validated and inserted in the

main database. Please ensure that the internet connection the computer running

OCM+ is using is capable of uploading files with huge dimensions (ex. 3G Wi-Fi is not

a good connection to upload this file due to the amount of traffic it will consume).

By hitting upload one final form will be presented:

Here the user should ensure that the destination is CENTER TBI and should hit the

Upload button.

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Restoring a closed data collection session

If a session was for some reason closed and a recording needs to be restored again

the button open can be pressed.

The dialog that opens can be used to reopen the file in order to upload the data to our

servers or to restore the recording session.

To reopen a file for inspection or to upload it is only necessary to double-click the

desired file.

To restore the recording session, the highlighted button must be pressed and the

recording resumes using the same profile as when it was closed.

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Manual packaging and uploading of data files

The data files can also be packaged and uploaded at a later stage, after the session is

closed using buttons in the Archive Tools section of the main menu tool bar. The data

packaging and upload procedures are the same as the ones described above.

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Appendix 1: Configuring ICM+ for CENTER-TBI

The first time ICM+ is run, some configurations need to be made before the data

acquisition process begins. These configurations are made in the Settings menu. This

menu can be found by clicking the Home tab and the Settings button.

In the Settings menu you will need to configure several things:

On the General tab:

o The Research Group/Centre identification will be a unique name in the

CENTER-TBI project that will identify the centre. This name should be

fully inserted in capitals (ex. CAMBRIDGE).

o The Data File Name Format will be used to configure the structure to

be used on the construction of the name of each data file. As each file

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generated in the study must have a unique identifier we agreed in using

a structure that uses the format highlighted in the picture. A description

on how to build this File Name format is presented further down in this

appendix.

On the Archiving tab:

o The Archive Folder Name Format will follow the same structure as the

Data File Name Format. This setting is not required for CENTER-TBI,

as it is only used for organising local archival storage of the data files.

o The default Destination should to be set to CENTER-TBI, but it is the

matching setting in the Project configuration that will ultimately take

precedence.

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On the Raw Data Rec tab:

o The Use ‘Start’ button to control Raw Signals Recording must be

checked if you are using ICM+ to record any data directly from bed

side monitors. This is because when ICM+ is used in conjunction with

Moberg CNSMonitor, it is the latter that will record the raw data from

bed-side monitors and so ICM+ does not need to do that, and so the box

may be ticked off. Otherwise it must be on.

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On the System tab:

o Set the Auto unlock program as user to Nurse. Setting the inactivity time

to a value greater than 0, eg 10 min, will cause the software to auto log-

in as that default user following a selected period of time without

interaction with the software (this will only happen of course if the

program was unlocked as another user)

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To build the Data File Name Format you will need to click the highlighted button and

the following form will appear:

In this form it is possible to add/remove any name element present in the Available

Elements menu.

The ‘_’ and any additional static text can be inserted by using the element ‘<text>’ and

inserting the text to be added manually.

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Appendix 2: ICM+ configuration folders and files

ICM+ uses two locations (configurable via the Settings form) to store all its

configuration files:

Location 1: C:\Users\<username>\Documents\ICM+.

There are two subfolders here:

‘Data’ folder, where all the data recorded during the acquisition process is

stored, and

‘Configs’ folder, used to store the data collection and analysis configuration

‘profile’ files, as in the figure below.

These files are written in XML making them easily editable. To do this double click on

the file, then right click anywhere on that window and select ‘View Source’. This will

open a Notepad with editable XML code. In here small adjustments can be made, ex.

changing the Moberg CNSMonitor IP address. Other, more involved configuration

modification should be done via the Signal Source and Analysis Configuration forms.

Location 2: C:\Users\Public\Documents\ICM+

Here all the environment configurations/settings are stored. This location contains a

folder called Plugins, where 3rd party function libraries reside, a folder called

TxtFilters, containing parsing definitions for different text format data files, and a folder

called sysconfig containing all the settings of the software, except the data collection

and analysis profiles which are store in the Location 1 (as above). Although these files

could be edited directly using a text editor ICM+ has specific user interface forms to

edit all aspects of the program functionality.

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Once notable exception is the file CTBIEvents.ini inside CustomForms folder, which

contains CENTER-TBI specific configuration for the clinical event form. This file should

be edited manually (in a text editor) with specific information provided to each

participating centre.

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Appendix 3: Editing ICM+ Projects

Projects contain various configurations specific to a particular research project. These

can be edited using Projects button in the main menu tool bar.

Clicking this button will open the Project Management dialogue, where you create,

copy, edit, delete, export/import selected projects to/from a file.

Double clicking on a selected project or clicking on Edit will open a Project Editor where

all the custom project settings can be modified.

The following screen shots describe the CENTER-TBI specific settings. These settings

would have already been preconfigured for you if you have copied the provided

project.ctb.xml file to the ICM+ sysconfig folder, or used the Project Manager to import

the settings from that file. Please do not modify those for CENTER-TBI project.

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1 . The project abbreviation will be part of the file name 2. ‘Data Folder’ is a local folder where the data collected as part of this project will be stored 3. Data File Name Format lists elements that will be used to create automatic file names for each new data acquisition sessions. Please note that elements listed here will have to be filled in (e.g Centre ID, or the anonymous Patient ID) at the New Data Acquisition form stage before continuing.

The data fields define placeholders for general clinical descriptors that characterise the patient at the time of admission to the critical care unit, that are useful to be kept together with the monitoring data.

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This is where events that are already defined elsewhere (in the Events form), listed in the left panel (1), can be assigned to the particular project (listed in the right panel 2.). Please note that CENTER-TBI uses a customised event form, selected using the ‘Custom Forms’ list box (3). It is possible however to add more events to the project but those will only be accessible from within the ‘Event List’ panel, toggled from the main menu tool bar panel, Charts section.

Here one can define the location and format of data archives as well as, essentially for CENTER-TBI: 1. This should be ticked in

order for you to be prompted to convert the file to HDF5 at the end of the recording session

2. the destination of the remote server for data uploads,

3. the data snapshot length and the data snapshot reminders

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Appendix 4: Registering ICM+

When ICM+ is successfully installed for the first time in a computer it needs to be

registered. This will probably already be done for you when you get the laptops, but if

any major update needs to be done you will have to register it again.

To register ICM+ you need to press the Registration button on the Home tab.

This will bring up the Detailed ICM+ License Info window where you will need to press

the Register New Key button.

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This will bring forth the ICM+ Registration Form and here you will have to press the

Copy Details.

This will let you paste the details anywhere you want. You will then have email those

details to Dr Peter Smielewski ([email protected]) or Manuel Cabeleira

([email protected]) so that we can generate your product key and send it to you.

You will then have to paste the Key to the highlighted space and click Register now. If

you are successful you will see the Registration successful dialogue.

mailto:[email protected]

mailto:[email protected]

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And your Detailed ICM+ License Info window should look like this:

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Appendix 5: Configuring the computer’s network

interface

To configure the Network of your Computer you need to open the Control Panel and

click on the ‘Network and Internet’ button.

In the new window that will open click on the ‘Network and Sharing Center’

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In the new window that will open click on the ‘Change Adapter Settings’

In the new window that will open click on the ‘Ethernet’

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In the new window that will open click on the ‘Properties’

In the new window that will open click on the ‘Internet Protocol Version 4 (TCP/IPv4)’

and on properties.

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In the new window that will open insert the new IP address that your machine will be

using. For CENTER-TBI, when CNSMonitors are used, this has to match the

CNSMonitor network subnet settings.

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Appendix 6: Description of connectors to selected

patient monitors

Moberg CNSMonitor

Crossed-over UTP (Ethernet) network cable (or possible even a regular UTP cable)

directly connecting the ICM+ laptop with Moberg CNSMonitor LAN1 port, or

A regular UTP network cable when a network infrastructure (eg network hub or router)

is in place (the connection is then to the hub/router or a designated network port).

Please make sure both the laptop and the CNSMonitor network interfaces are correctly

configured (ie both are on the same IP subnet). Details of CNSMonitor network

configuration can be found elsewhere, in the CNSMonitor manual, while step by step

instruction for setting up the network interface on the ICM+, Windows, laptop can be

found in Appendix 5.

Philips Intellivue

USB-to-Serial adapter connected to the computer

Monitor requires a cable with RJ45 (network type) connector at one end and a male

RS232 at the other (as depicted below in a MP70 monitor):

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MX800: The cable visible in the photo connects the MIB/RS232 port on the Intellivue

monitor and the internal PC’s USB port, using a USB-Serial adapter. Its pin

configuration is as described above for MP70.

GE Datex Ohmeda S/5


Standard null modem serial cable connecting the monitor (fig below) and the USB-to-

Serial adapters

GE Carescape B 650/850


Standard null modem serial cable connecting the two USB-to-Serial adapters

ATEN UC-232A USB-to-Serial adapter connected to any USB port s on the Carescape

monitor

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Appendix 7: Preconfigured users and passwords

Administrator – 2718

Manager – 1618

Operator – 3142

Nurse – 1414

The users, their passwords, and their rights are fully configurable in the software, using

Users form. The default users have been chosen to fulfil the following roles:

User Role

Administrator Complete access to all the software configuration options, the users and passwords

Manager Access to all the configuration options, except the users and password. This will normally be the user to do the entire configuration needed for data collection.

Operator Control of the data collection process using preconfigured profiles, and changes to the charts layout and properties.

Nurse Access to clinical annotations tools only. This should be normally set up as the default user kept logged-in during the data collection process, in order to prevent any inadvertent disruption to data recording but at the same time allowing and encouraging quick access to the clinical annotations.

Guest This ‘user’ has no rights, making it impossible to interact with the software in any way.

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Appendix 8: Configuring Moberg network

The first time the Moberg device is connected to ICM+ the network between the

devices must be configured as both the CNSMonitor and ICM+ must sit on the same

network. To do this you only have to make sure that the IP addresses on both

machines belong to the same subnet. To do this you must look into two things:

The Ip address ex. ‘192.168.100.200’

The Subnet mask ex. ‘255.255.255.0’

To configure the IP address and the subnet mask on the ICM+ laptop, refer to

‘Appendix 5: Configuring the computer’s network interface’. Further down in this

chapter you can find how to do it in the CNSMonitor side.

You can define IP addresses and subnet masks yourself, but if you have an IT

specialist he should be the one doing this part. The only constraint is that no other

machine on the same network can share the same IP address with any other machine.

If you are doing this yourself you should first check if ICM+ and Moberg are the only

machines on the network (this will happen when both devices are directly connected

with a LAN cable) or if there are more machines sharing the network.

In the first case you will have total freedom and you can choose the IP addresses (one

for the CNSMonitor and one for ICM+ laptop) that you want, as long as they are within

the same subnet. In the second case you should try to find out the subnet mask and

the IP of one of the machines already on the network.

As an example:

If the subnet mask is 255.255.255.0 and the IP address of another machine in the

same subnet is lets say 192.168.100.200, the new IPs you chose for the ICM+ laptop

and the CNSMonitor must start with 192.168.100.XXX. The last three digits must be

different for every machine on the same network and must be between 0 and 255.

If the subnet mask is 255.255.0.0 the IP addresses must share the first 2 numbers (dot

separated) and will be: 192.168.XXX.XXX.

To check the IP address

already configured in the

CNSMonitor you need to click

the System Configuration

Menu and then click on the

System Information button.

This will bring up a window

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that will contain the current IP address that the monitor is using.

If you need to configure a

different IP address on the

CNSMonitor you first ne need to

click on the System Admin

button and insert the password

that is asked. This password

should be ‘moberg’.

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After this you will be presented

with the System Administrator

Menu and here you want to click

on the Network Setup button.

In the Network Setup Menu you

will want to click on the Network

Configuration button.

In this menu you will be able to

change both the IP address and

the Subnet mask.