D1-jw ClinicalModality -Emulation-VPT-MDIB- DBtools . Prepared by Jan Wittenber,

1. Clinical Modality - Emulation use context- Ventilated Patient Transfer (VPT) - Ventilator Modality- DCM RDC- DB tools- Overview D1-jw ClinicalModality-Emulation-VPT-MDIB-DBtools. Prepared by Jan Wittenber, JWG ISO /IEC/IHE PCD RTM-VentilatorNomenclature_DPI-ICE-PAC/IEEE11073 MDDL/PHD JWG-VentilatorHarmonization- DB tools

2. Introduction This document has two main parts, the first, about an “MDIB Emulator” DB tool, being a follow-on to the second, about a [Ventilator] semantic architecture/nomenclature design DB tool. In between were a number of in-depth and collaborative work with an inter-disciplinary, inter-standards “joint working group (JWG)” focusing on Ventilator Nomenclature and related clinical and medical device-based networked systems. This document does not cover substantial DB tool work at NIST, with several related tools, including - the “ICS Generator” for modeling medical devices with IEEE 11073 (MDC) MDDL using a GUI diagram-oriented editing capability,, currently upgrading; and -- the “RTM MS (Rosetta Terminology Mapping)” tool under development. Hopefully, harmonization “connects the dots”, so to speak, with reusable threads! After all, “gaps” are often configuration-related, so the more safe and effective “rapid” that can be, would undoubtedly help serve as a platform for extending into other applications on a systematic basis. 1 Based on Microsoft Access 2007; available from author through and for use in Vent Nomenclature JWG JWG-VentilatorHarmonization- DB tools

3. Clinical Modality - Emulation use context- Ventilated Patient Transfer (VPT) - Ventilator Modality- DCM RDC- DB tools- Overview – Part 1- MDIB tool- Overview D1-jw ClinicalModality-Emulation-VPT-MDIB-DBtools. JWG ISO /IEC/IHE PCD RTM-VentilatorNomenclature_DPI-ICE-PAC/IEEE11073 MDDL/PHD JWG-VentilatorHarmonization- DB tools

4. Introduction This [sub-]document is an extension of the “Ventilatory Modality – Dbtool” document, adding a “Clinical Modality – Emulation DB tool”, focusing on “Ventilated Patient Transfer (VPT), as part of a harmonization effort spanning several standards groups, as ID’d in the title page. Life is too short to elaborate on all this right now. Since this covers a substantial “dynamic range”, it takes a number of perspectives and often elaboration and abstraction simultaneously. Sorry about that; seriously– but that’s why there’s a real need for a flexible and systematic “name space”, which these tools attempt to embody, based on adapting the ontological perspective to clinical and esp. ventilatory management workflow. The Emulator tool described facilitates automated definition, interchange, and integration in a “Medical Device Info Base (MDIB)”, which is sized initially exactly for 7 OpSettings described in harmonization documents. The remainder of the paper is the initial Ventilatory Modality Dbtool paper; it will be updated after and possibly annotated where any significant differences exist that affect Emulator use. 1 Based on Microsoft Access 2007; available from author through and for use in Vent Nomenclature JWG JWG-VentilatorHarmonization- DB tools

5. Background • There are several E size vsd diagrams that have been developed1 and can be used for an overview of Clinical workflow modeling, including DCM/DAM in UML, clinical work flowcharts focusing on Ventilator and infusion (e.g. PCA) device participation in clinical activities. • The Emulator tool covers functionality in a sequence of “MDIB” generation and management capabilities, as follows. • Preparation of originating EVent Report Info (EVRI) from SDO standard doc (e.g. IEEE 11073-PHD) • Export to spreadsheet format • Interchange [through email] • Import from [saved email] • Show/edit MDIB [RDB query on linked imported EVRI] • Extend (Local and/or Global) MDIB for collaborative work (in VPT RDC use context/cases). 1 Based on Microsoft Access 2007; available from author through and for use in Vent Nomenclature JWG JWG-VentilatorHarmonization- DB tools

6. Emulator tool – Overiew – GUI An attempt will be made to be able to do clicks or Enters to pace composition of the GUI. 1) To start: Dbl-click Switchboard 2) Click “RDC Emulation” to launch “MDIB “Splashboard” window 3) MDIB form has a procedural orientation with pushbuttons. Size, subview and position on screen can be adjusted dynamically 4) Remaining area is used for dynamic sub-windows invoked by pushbuttons JWG-VentilatorHarmonization- DB tools

7. Emulator tool – Overview – GUI – MDIBs in VPT Clinical Use Context The MDIB contains the (relative) Vent OpSettings Vector at a given topological node in the VPT system. The main table is an editable Form of the relational DB transform of the OO MDIB. The vector chronology terminates in ICU and can become a “Medical Record Element (MRE)” recording the episode. The OpSettings Metric [value] Set, or “vector”, originates in [OR/]PACU and is exported to an intermediary, e.g. a Transport Vent The vector may be used for settings continuity and adjustment during transport. JWG-VentilatorHarmonization- DB tools

8. ATC Ventilator – Domain Model – Dynamic basic concepts Base concepts are focal points, or Areas of Interest (AoI) in function-phase space for variables related to SCADA, CDS, EMR, and other application scopes. Notation faciliates specification of “Set” Breath (Expected Value) Patterns, as well as recognition of resultant Breath Patterns through Observations. A major simplification is treating “inflation” as a transform in which either P or Q (Flow) are constant over Insp. APNEA CRITERIA Breath Control Frame sequence for an “SIMV ”-like Ventilation pattern. ∑ BR Annot’ns MultiBeat Patterns, e.g. Dyspnea Leak compens’n BREATH RATE TOTALS and related STATISTICS Various Intervals can be defined and measured for pattern measurements. INVERSE I:ER “APRV” NAVA(CRG) CPAP dT : { I, E, I+E, I:E } A Vent Br Vent Br Vent Br ↑AssurLevel, WoBv) AssurLevel, ↑ WoBp N N MT_BT iii Eff Aff MINUTE COLUME TIDAL VOLUME AIRWAY FLOW AIRWAY PRESS Mandated  Int(Art) preempts Ext(Nat) Synch’z’n Directed dT between partial Flow zero crossings constitutes a Breath . There are Int and Ext inducements. B B B INDP PV DRYYINH INDP PV DRYYINH’ ATC BAROM PRESS CALIBRN JWG-VentilatorHarmonization- DB tools

9. Emulator tool – Overview – GUI – PDU Generation PDU generation format is compatible with infrastructural [integrated clinical! : ] environment (no caps! ; ). Spreadsheet format before optimizing format Fully compressed format turns 4 hex chars to SHORT Since the “Output File” is a .txt file, it can be operated on in CMD mode SHOW MDER HEXATEXT “Concrete” Syntax displays optimized output in “hexatextual” format. File is a .txt exported from spreadsheet using MDIBtool. Ditto, operated from RUN mode via DB RunCommand Macro Function modules exported from Macros are adaptaqble in ‘native’ code (e.g. VB) JWG-VentilatorHarmonization- DB tools

10. Emulator tool – Overview – GUI – “Std To PDU (S2pdu)” Initial EVRI intermediate transforms are by text copy/paste from Std spec, in this case IEEE 11073-20601 PHD (H.2.4.1) Metric Numeric sequence, adapted for this purpose (exporting Vent Mode (e.g. PSV) OpSettings. SDO standard is a pdf in media distribution DIR (c:\Temp \MDIB-Emulation\) Optimized format (at left). DB query-linked-intermediate format (at right) STD source can be displayed from Temp DIR via Cmd line or operated on as any other pdf file. MDER “hexatextual” source format; Format has OID JWG-VentilatorHarmonization- DB tools

11. Emulation tool – “MDIR[…MDIB]” – DIRectory structure Local RDC partition working directory contents. Only the .txt is needed to interchange optimized payload, which is presently MDER but “is architected” for additional presentation methods, esp. PER XML transformation is available throught the [R]DB platform.. D2bjw The upper namespace partition is a metrastructure for developmental and functional operational constructs, such as this Emulator; it is “DIR”-oriented. The lower partition is for operational objects distributed in a clinical context. As shown, several DIRectories are co-located for distribution/integration efficiency. JWG-VentilatorHarmonization- DB tools

12. Clinical Modality - Emulation use context- Ventilated Patient Transfer (VPT) - Ventilator Modality- DCM RDC- DB tools- Overview – Part 2- DB tool- Overview D2bjw This part needs updating overall based on development; some stickies like this may be added in particular places. JWG-VentilatorHarmonization- DB tools

13. Introduction The “DB Tool” is a relational DB1 that comprises a set of tables, queries, forms and reports substantiating the Vent “Modality” Framework to facilitate development. Overview slides: • Modality Frmwk • Data entry “Form” • Examples • “Standard” • MT (i), BT(FC): aka “A/C” • MT (ii), BT (PCPS): aka “SIMV” • MT (iii), BT(PS): aka “PSV” • Mfr-specific, based on MT(ii) BT(BPAP/CPAP), value-adding • “VM targeting Auto/Feedback Control (AFC) function. • Schema • Table Examples • Inspiration • Initiation • Breath Type • Inflation • Termination • Variables • Background • MT and BT depictions 1 Based on Microsoft Access 2007; available from author through and for use in Vent Nomenclature JWG JWG-VentilatorHarmonization- DB tools

14. Modality Framework editing “Form” The following Figure is a composition of the “ModalityFrmwk” Form, which is used to facilitate editing. Several “sub-Forms” are used to group Properties allow management of details. Several Modalities in the DB are shown in subsequent slides. “NOS” (Not Otherwise Specified”) is used for unspecified values or template purposes. “Drop-down List Selector” controls are used to select choices from underlying [relational] Tables; Selector “window” shows “Mnemonic” of term selected. Various other attributes are shown during selection. “Variables” table listing; use Scroll Bars to review entire table contents. “Modality”:”Mode Type (MT)” relation “Inspiration Init” sub-Phase Inter-/Multi-Breath “ Automatic Feedback Control (AFC)”-related content, “[Insp] Breath Type (BT) relation, comprising “Inflation” and “Termination” sub-Phases. AFC “Method” and Variables “Vector” relations Note @ provision for “Intra-Breath AFC”. “Expiration” Phase JWG-VentilatorHarmonization- DB tools

15. Modalities – MT(i) – Example: “aka A/C” “A/C” typically comprises a regular pattern of assured breaths, typically “Flow Controlled” (FC). This sub-view is shadowed since it is the same as the “<NOS>” Template JWG-VentilatorHarmonization- DB tools

16. Modalities – MT(ii) – Example: “aka SIMV” “SIMV” typically comprises a regular, alternating pattern of assured and unassured breaths, in this case BT(PCPS). “Sequence No.” denotes expected sequence after regular “assured” BT. JWG-VentilatorHarmonization- DB tools

17. Modalities – MT(iii) – Example: “aka PSV” “PSV” typically comprises a [ir]regular pattern of unassured breaths, typically “Pressure Supported”, BT(PS). JWG-VentilatorHarmonization- DB tools

18. Modalities – MT(ii) - “aka BPAP/CPAP Mfr-VMtarg” Customization can be done in several ways. In this example, a specialized, “Manufacturer-specific” “Auto/Feedback Control (AFC)” function is used to achieve Minute Volume Targeted optimization, based on a “standard” template for MT(ii)-BT(BPAP/CPAP). A “standard” Type may be used as a starting “Template” to define a “custom” Modality Mfr-specific type is one of several AFC Types SETting, MANipulated, PROcess, and ERRor Variables may be associated for definition purposes. JWG-VentilatorHarmonization- DB tools

19. Schema Various Tables are defined and related, as shown in the following “Relationships” table/view. This view is used in various Queries to join together related information, based on the [SQL] Query specification. Following slides show the content of various key Tables. “[Insp] Breath Type (BT) relation, comprising “[Insp] Inflation” and “[Insp] Termination” sub-Phases. “Mode Type (MT)” table “Expiration” Phase table “Inspiration Init” sub-Phase “Variables” relations not shown Inter-/Multi-Breath “Automatic Feedback Control (AFC)”-related content. JWG-VentilatorHarmonization- DB tools

20. Table Examples - [Insp] Initiation Columns of the Table serve a variety of relational purposes, including numerical identification (“InspInit_ID-Num”), Phase context (“InspInit_ID-Seq”), notational abbreviation (“InspInitID-Mnem”), general description (“InspInit_Desc”, and functional rationale (“InspInit_Rationale”, as shown in the following listing, which is a “basic Report” from the DB. JWG-VentilatorHarmonization- DB tools

21. Table Examples - [Insp] Breath Type Key attributes of the Breath Type (BT) table are shown. BT comprises Inspiration Inflation and Termination sub-phases and is provisioned for an intra-breath AFC element. These are “pointers” to records of the related “Type” tables. “HF” type variations should probably be managed in a separate Profile. JWG-VentilatorHarmonization- DB tools

22. Table Examples - [Insp] Inflation Key attributes of the Inspiration Inflation phase table are shown. Rationales should be added to clarify purposes of transfer function. JWG-VentilatorHarmonization- DB tools

23. Table Examples - [Insp] Termination Key attributes of the Inspiration Termination phase table are shown. Rationales should be carefully defined. [An update is pending…] JWG-VentilatorHarmonization- DB tools

24. Table Examples - Variables Key attributes of the Variables table are shown. Checkboxes are used to denote that VARiations are “discriminated”, e.g. “MEASured”, “SETTing”, or “High/Low Limit Alert” TYPEs. Dimensions, or Units of Measurement, may be added; note that some variations may pertain to Units of Msmt, which could easily be captured in the table for clarity. JWG-VentilatorHarmonization- DB tools

25. Background - Mode Type Mode Types are shown with Breath Types as analogous with “black boxes”, denoting that [virtually] any BT may be substituted, per Ontology. A/C [FC] [FC] [FC] [FC] [PS] [PS] [PS] Increasing level of Assurance of Delivered Breaths [PC] SIMV [PC] Increasing Patient Work of Breathing (WoBp) CPAP BT “boxes” should be revised to better interleave “inter-breath” intervals, esp. for BPAP/CPAP BT’s CPAP This and the following slides are taken from “Ventilatory Modality – Framework and Overview – d4jw”, as adapted based on review and subsequent discussion. JWG-VentilatorHarmonization- DB tools

26. Background- Breath Type - Relationships Breath Type Control Variable relationships are depicted in the following figure. These are abstracted in the following slides. VTVM may be log scale V VM VT V Q P PIP P Pplat PEEP Patm Ti Te Tbr I:ER = Ti/Te RR = 1/Tbr T V: Volume F: Flow P: Pressure T: Time [FC Breath] [PC Breath] Legend Note: in 2-D views, waves are shown vertically, synchronized @ T. See also slide “Background – Defining a Breath”. Breath Initiation “Window” [PS Breath Inspiration Initiation & Termination Impulse types Spontaneous Mandatory [f(T)] JWG-VentilatorHarmonization- DB tools

27. Background- Breath Type – Depiction - Overview Breath Type morphology is depicted in the following figure, with “Ventilator”-related detail opaque and detail shown in the next slide. The figure is intended as a “lead-in” to showing detail BT definition and specification. At this level of abstraction, it is easy to “lose” significance of the distincions between “SET” and “OBServed” “Breaths”. JWG-VentilatorHarmonization- DB tools

28. Background- Breath Type – Depiction - Detail Breath Type conduction “path” variations are depicted in the following figure. In the Termination sub-Phase, path branches are denoted with circled letters for reference purposes. Detail definition is in progress, as part of recent Work Item #2 from 14Apr2010 tCon. PEEP/CPAP JWG-VentilatorHarmonization- DB tools

29. Clinical Modality - Emulation environment- Ventilated Patient Transfer (VPT) - Ventilator Modality- Detailed Clinical Modeling (DCM) Ontology D1-jw ClinicalModality-Emulation-VPT-MDIB-DBtools. JWG ISO /IEC/IHE PCD RTM-VentilatorNomenclature_DPI-ICE-PAC/IEEE11073 MDDL/PHD JWG-VentilatorHarmonization- DB tools

30. Introduction Some additional views are included to place this in the context of harmonizing standards activities. Ontological views are intended to facilitate derivation of a systematic if not formal semantic architecture, which is another way of saying “namespace”, or naming framework. The Ventilatory domain spans a significant number of orders of magnitude of space-time, or “4D”, ranging from closed loop control with millisecond latencies to etiological characteristics of chronic respiratory disease with multi-year time constants of pathology evolution. Compounding the problem is that procedures using ventilators are in the more challenging realm of safety and essential performance, and reliance on distributed data communication for support of the “mission” function, i.e. patient ventilation, is a major target in tradeoff analysis. Viewing ventilator dynamic operation in the small time constant RT domain as a clinicological function-phase relation helps to focus systematic RT relationships among major system components, mostly ventilator, but patient and operator or clinician as well. Ventilators must also pursue multiple RT objectives within the RT spectrum. As a result, in order to visualize phenomena, the resulting ontology must be able to be “navigated” efficiently, which leads to identifying the main nomenclature identities. These identities are typically “base concepts” around which related variables cluster and from which specialized, or differentiated concepts derive, usually predicated on some fundamental relstionships with other base concepts and derivatives. The next slides describe a dynamic ontological perspective, extending the previous slides in a more “finite state element/model (FSE/FSM)” and “object orientation” (OO) to gain simplification of generalization/specialization and scalability through hierarchical and relational structures. JWG-VentilatorHarmonization- DB tools

31. Ventilator – Domain Model – “Breath[ing]” Patterns Mode Type (MT) and Breath Type (BT) variations are systematized into 3 MT (e.g. I – iii) and several fundamental BT’s (Vol-assured (e.g. aka VC, PC), and Pressured Supported (PC). In general, the interventional goal is to maximize “assurance” of needed ventilation but eventually to minimize Ventilator “Work of Breathing” while maintaing patient stability. BT : typvol-assured and Vent-initiated and –terminated (@ dT) but may be Pat-On/Offset facilitated. MT I Ii iii Vent Br Vent Br Vent Br BT : typ. alternating vol-assured and/or press-support (may be multi-phasic); typ. Sync’d if coincidental Vent Br Vent Br Vent Br Vent Br Vent Br Pat Br Pat Br Pat Br CPAP Vent Br Vent Br BT : typ. Press. Supported with CPAP; relatively long up to inverse I:E ratio (“Press Rls”) variations. Pat Br Pat Br CPAP JWG-VentilatorHarmonization- DB tools

32. ATC Ventilator – Domain Model – Annotations Annotations associate features in various areas of interest (AoI); notation may faciliate specification of “Set” Breath Patterns as well as recognition of resultant Breath Patterns through Observations. A major simplification is treating “inflation” as a transform in which either P or Q (Flow) are constant over Insp. APNEA CRITERIA ∑ BR Annot’ns MultiBeat Patterns, e.g. Dyspnea Leak compens’n BREATH RATE TOTALS and related STATISTICS Various Intervals can be defined and measured for pattern measurements. CPAP dT : { I, E, I+E, I:E }, Br, Br2Br, …} A Vent Br Vent Br Vent Br N N MT_BT iii Eff Aff MINUTE COLUME TIDAL VOLUME AIRWAY FLOW AIRWAY PRESS Mandated  Int(Art) preempts Ext(Nat) Synch’z’n PHASE [A] SYNCHRONY STATS TIDAL VOL SETTING Directed dT between partial Flow zero crossings constitutes a Breath . There are Int and Ext inducements. B B B MAX INSP AWP LIMIT SETTING INSP AWP SETTING INDP PV DRYYINH’ PEEP/CPAP SETTING[s] + MULTI-MODAL, e.g. BIPHASE SETTINGS JWG-VentilatorHarmonization- DB tools

33. Ventilator – Domain Model – Ontological perspective Applied MDIB object and related naming patterns follow function-phase dynamic relational model. Annotations are being defined as key features that characterize definition of “set” Mode and Breath Types, as well as related Observations used to support clinicology, esp. diagnostic and therapeutic management using Ventilators and related modalities. 1 Based on Microsoft Access 2007; available from author through and for use in Vent Nomenclature JWG JWG-VentilatorHarmonization- DB tools

34. Ventilator – Activity Model – Clinicological perspective Ventilation and related nformation are closely tied to related clinical modalities, such as oxygenation, in a networked pattern of clinical modalities and collaborative and shared information processing and artifacts, such as event report and medical record components of which they facilitate detailed definition. “Reasoning” logic follows physiological relationships between optimization loops Operational realization of VPT focusing on “Maintaing Relative Stability” using optimjization dynamics as a reference/guide. Ventilation optimization involves tuning settings using key ventilatory control variables as well as adapting to oxygenation dynamics 1 Based on Microsoft Access 2007; available from author through and for use in Vent Nomenclature JWG JWG-VentilatorHarmonization- DB tools