1. Resp/Vent Nomenclature – Modeling dynamic variables IEEE 11073-ISO SC4 19223-IHE PCD RTM JWG D3G_9SEP14

2. Overview IEEE 11073-ISO SC4 19223-IHE PCD RTM JWG D3F 1.Scope is limited to defining dynamic variables, i.e. breath types, rates, and volumes 2.Purpose 1.Primary purpose is to define a fundamental set based on ISO SC4 methodology that can be used as a basis for data logging of ‘dynamic’ variables, i.e. breath types, rates, and volumes, such as tidal and minute volume. 2.Secondary purpose is to show how fundamental breath type variables can be used to explain ‘traditional’ connotations such as ‘spont[aneous]’ and ‘mand[atory]’. 3.Approach 1.Harmonization is based on alternative modeling perspectives 1.Synergy: breaths are viewed as holistic, or system-level co-actions of patient and ventilator.Synergyholistic 2.Phasing: features are viewed as phased element-level actions of patient and ventilatorPhasingelement Compositional correspondence: several Rate variables are related to [four] fundamental breath types. 2.Several application examples are described: 1.Rate: variables are summated w.r.t. a typical modal pattern (e.g. SIMV) 2.Nomenclature: RefID formulation is shown for common RESP_RATE variations. 3.Volume: several variables related to “Exhaled Minute Volume” are derived Modal correspondence: several key variables are related to common Ventilator Modes. 2

3. Synergy perspective 1.Breath types represent fundamental co-action patterns w.r.t. patient and ventilator. 2.Refer to following diagram for derivation of breath types and table for identification of key rate relationships ◦Breath types are composites of co-active relationships and named according to common usage. ◦Rates may be ascribed to various elements or subsets of graph in the diagram. IEEE 11073-ISO SC4 19223-IHE PCD RTM JWG D3F Standardised [Rate] Term ventilator-initiated inflation rate patient-triggered primary-inflation rate unassisted (spontaneous) breath rate patient-triggered inflation rate patient-triggered support-inflation rate (total) inflation rate patient-initiated rate patient-triggered concurrent-inflation rate unassisted concurrent-breath rate total respiratory rate unassisted & supported breath rate 3

4. Phasing perspective 1.Breath types represent fundamental phasing relationships, primarily w.r.t. initiation. “SD” refers to “Start” and “Delivery” phasing elements. 2.Refer to following table for derivation of breath types ◦Breath types are n-tuple composites of phasing sequences, e.g. n=2 (for S & D) in the following table; precision may be increased by extension, for example, by adding an “E” (End) phase ◦SD Type correspondence as shown in previous diagram, e.g. Unassisted (P), Supported (S), Assisted (A), Controlled (C). ◦Rates may be ascribed to time-ordered occurrences as shown in the annotated diagram beneath the table. IEEE 11073-ISO SC4 19223-IHE PCD RTM JWG D3F 4 SDSD-code description and examples PThe ventilator performs no action on behalf of the patient: initiation, pressure and flow/volume are determined by the patient. Example: unassisted spontaneous breaths that are superimposed on an APRV, BiLevel or CPAP baseline pressure. SThe patient initiates a support inflation (an inflation type that can only be initiated by the patient and that is intended to be terminated by the patient) in which the inspiratory pressure is raised above baseline to support some portion of the work of breathing (WOB). Includes: PAV inflation type, where the ventilator provides a level of support proportional to patient effort. AThe patient initiates a primary inflation (an inflation type that is assured to be delivered at or greater than the set rate, according to the selected mode) and is intended to be terminated by the ventilator. The breaths are classified as being assisted by the inflation. The inflations are sometimes described as synchronized. CThe ventilator initiates a primary inflation (an inflation type that is assured to be delivered at or greater than the set rate, according to the selected mode) and is intended to be terminated by the ventilator. The breaths are classified as being controlled by the inflation. This type also applies to “backup” safety breaths and to APRV, Bi-Level or CPAP baseline pressure changes, whenever the initiation of the primary inflation is largely determined by the ventilator.

5. Relational correspondence The following table shows a relation mapping terms based on the alternative perspectives. IEEE 11073-ISO SC4 19223-IHE PCD RTM JWG D3F Phasic perspective typePSAC Synergistic perspective type UnAssistedSupportedAssistedControlled Related "rate" terms Mappings (x): ventilator-initiated inflation rate X patient-triggered primary-inflation rate X unassisted (patient-initiated) breath rate X patient-triggered inflation rate XX patient-triggered support-inflation rate X (total) inflation rate XXX patient-initiated rate XXX patient-triggered concurrent-inflation rate +X unassisted concurrent-breath rate +X total respiratory rate XXXX unassisted & supported breath rate XX ‘traditional’ (Legacy) spontaneous breath rate XX ‘traditional’ (Legacy) mandatory breath rate XX 5

6. Example applications – Rate IEEE 11073-ISO SC4 19223-IHE PCD RTM JWG D3F 6 Note: See below for annotation key for this particular (preliminary) diagram.

7. Example applications: Nomenclature RefID Application for defining Nomenclature “Reference IDs” is characterized in the following example, for key “Resp Rate” variations. Discriminator tags (“P”, “S”, “A”, “C”} shown in the “Phasing perspective” table are formed into a char string denoting summary formulation, in order to facilitate systematic computation. IEEE 11073-ISO SC4 19223-IHE PCD RTM JWG D3F 7 Base term: MDC_VENT_RESP_RATE [existing term code 2::20514] REFID (as observations, not settings)Equivalent to MDC_VENT_RESP_RATE_BTSD_PSBTSD = patient | supported (aka ‘traditional spontaneous’) MDC_VENT_RESP_RATE_BTSD_ACBTSD = assisted | controlled (aka ‘traditional mandatory’) MDC_VENT_RESP_RATE_BTSD_PSABTSD = patient | supported | assisted MDC_VENT_RESP_RATE_BTSD_CBTSD = controlled

8. Example applications – Volume IEEE 11073-ISO SC4 19223-IHE PCD RTM JWG D3F 8 Exhaled Minute Volume Terms Spontaneous' & 'Mandatory' Rate terms ISOLegacy ISOLegacy 1exhaled MV (= 3+5) 'spontaneous' breath rate patient-triggered rate + unassisted ratesupport inflation rate + unassisted rate 2 mandatory MV = set MV = set (f x Vt) 'mandatory' inflation rateventilator set rate assisted-breath rate + controlled-breath rate 3primary-inflation MV (=2+4)mandatory MV 4assisted MV 5 spontaneous [adjunct] (demand + support) MV spontaneous (demand + support) MV (RC) 6support MV spontaneous (support only) MV (some manufacturers) Several volume-related term derivations and relationships to rate terms are listed in the following table.

9. Modal context correspondence Context-sensitive, modal relationships are shown in the following table. [Note: ID tags are used only for concise reference in the table.] IEEE 11073-ISO SC4 19223-IHE PCD RTM JWG D3F IDVariableContextual (w.r.t. Modal pattern) Fundamental (Context free)CMVA/MIMVSIMVCSV X0Set Vent inflations Br/minX0 None X1Pt-triggered /min (inclusive of X3)X1 X3 X2UA Initiations /minX2 1,2 X2 2 X3Pt-init'd 'support' infl'ns /minX3 1 X3 X4Total number of infl'ns initiated /min(≡X0)X4X0+X3 (≡X3) Other X5Total respiratory rate (ISO)(≡X4)X0+X2+X3 X2+X3 X6Vent-initiated infl'ns/min (ISO)(≡X5≡X4≡X0)X4-X1(≡X0) None XsSpont (ISO)X1X2+X3X1+X2X2+X3 3 XmMand (ISO)X0X4-X1X0 None Xs'Spont (“Traditional")XsX2+X3 5 Xs Xm'Mand (“Traditional")XmX4 5 Xm Xm 4 Footnotes 1Typ. @ Exp phase (but may be concurrent @ Infl'n) 2 @ Support=Off 3Apnoea/Backup ==> Mand 4Vent-term'd ==> Mand @ “Trad." 5Key difference @ ISO vs.“Trad." All Br ==> Mand @ “Trad." X1 not Spont @ “Trad." Vent- term'd ==> Mand @ “Trad." 9