An instrument, machine, appliance, implant, software or other article intended to be used for a medical purpose.

Data Element
Ventilator Mode
Description

The mode of mechanical ventilation if the patient is receiving mechanical ventilation. Could refer to LOINV 20124-4 for options.
Submitted By: Ali Abbasi MD- on behalf of the I-SPY COVID investigators / I-SPY COVID Trial Investigators
Data Element Information
Data Element Description The mode of mechanical ventilation if the patient is receiving mechanical ventilation. Could refer to LOINV 20124-4 for options.
Use Case Description(s)
Use Case Description The ventilator settings are crucial data elements both for clinical care, and also for research, pandemic preparedness, quality improvement. For clinical care, interoperability is crucial because critically ill patients are often transferred to tertiary or quaternary care centers when the complexity of their condition demands a higher level of care. These data elements are also really important in decision support systems in critical care that may require access to these data elements via an API. (e.g. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3996182/).

In terms of quality improvement, these data elements are key elements needed to assess the safety of treatments in critical care and to improve the quality, for example to reduce rates of healthcare acquired infections. This has been stressed in a previous submission (https://www.healthit.gov/isa/taxonomy/term/2551/level-0), which highlighted the public health needs for this data element.
Estimate the breadth of applicability of the use case(s) for this data element There are more than 5 million critical care admissions in the US annually [1] and about 40% of patients in the ICU are receiving mechanical ventilation at any given time [2]. Amongst patients receiving mechanical ventilation, mortality rates are as high as 50%. Therefore, there is a huge need for improving clinical care, quality of care, and clinical evidence in this patient population. Additionally, there are significant disparities in mortality of relevant conditions (e.g. COVID-19) by race/ethnicity, which highlights the need for additional research to address these disparities

[1] https://www.sccm.org/Communications/Critical-Care-Statistics#:~:text=More%20than%205%20million%20patients,of%20comfort%20for%20dying%20patients.
[2] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3840149/)
[3] https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2804391#:~:text=Results-,From%20March%201%2C%202020%2C%20through%20February%2028%2C%202022%2C,a%20mention%20of%20COVID%2D19.
Link to use case project page https://www.quantumleaphealth.org/portfolio/i-spy-covid
ONC Priority
  • Mitigate health and health care inequities and disparities
  • Address public health interoperability needs of reporting, investigation, and emergency response
Maturity of Use and Technical Specifications for Data Element
Applicable Standard(s) Airway type LOINC LL5542-7
PEEP LOINC 20077-4
Pressure support LOINC 20079-0
Plateau Pressure LOINC 76259-1
Tidal Volume LOINC 76221-1
Respiratory Rate LOINC 33438-3
https://loinc.org/LL5542-7
Additional Specifications https://build.fhir.org/ig/HL7/fhir-saner/ValueSet-VentilatorObservations.html
Current Use (Level 2) Captured, stored, or accessed in multiple production EHRs or other HIT modules from more than one developer
Extent of exchange (Level 0) Limited environments, such as connectathons or pilots
Supporting Artifacts ISPY COVID trial
MIMIC data elements
Potential Challenges
Restrictions on Standardization (e.g. proprietary code) Standardization of this data element is likely to require some work on definitions around the measured parameters (peak inspiratory pressure and plateau pressure), because measurement is not standardized across ventilator devices. Ventilator settings (PEEP, PS, RR, Vt) are more standardized but it needs to be assured that these parameters are validated, rather than the raw data pulled directly from the ventilator (in most settings these are validated by the bedside nurse or respiratory thearpist).
Restrictions on Use (e.g. licensing, user fees) None
Privacy and Security Concerns None beyond usual health data
Estimate of Overall Burden Burden is likely to be moderate, given the need to standardize the data flow for extraction of this data element from the ventilator, verification by bedside providers, and storage in structured data field.
ASTP Evaluation Details
Each submitted Data Element has been evaluated based on the following criteria. The overall Level classification is a composite of the maturity based on these individual criteria. This information can be used to identify areas that require additional work to raise the overall classification level and consideration for inclusion in future versions of USCDI
Criterion #1
Maturity - Current Standards		 Level 0 - Data element is not represented by a terminology standard or SDO-balloted technical specification or implementation guide.
Criterion #2
Maturity - Current Use 		Level 0 - Data element is captured, stored, or accessed in limited settings such as a pilot or proof of concept demonstration.
Criterion #3
Maturity - Current Exchange		 Level 0 - Data element is electronically exchanged in limited environments, such as connectathons or pilots.
Criterion #4
Use Case(s) - Breadth of Applicability		 Level 0 - Use cases apply to a limited number of care settings or specialties, or data element represents a specialization of other, more general data elements.
Evaluation Comment This data element is a specialized use or subset of the existing data element Device Settings in the Medical Device data class https://www.healthit.gov/isa/taxonomy/term/2551/level-0

Comment

Submitted by mfaughn on

This data element was reviewed by the IEEE 11073 Point-of-Care Devices WG.  This WG includes medical device experts, terminology experts, and clinicians.  Among these are an anesthesiologist who participates in the standardization of ventilator terminology.  We find that the submission includes inaccurate or inapplicable references for the values in "Applicable Standard(s)" and "Additional Specifications".  The LOINC code 20124-4 is an appropriate observation identifier.  A collection of appropriate observation values that correspond to the observation identifier exists in "IEEE Standard for Health Informatics--Device Interoperability Part 10101: Foundational--Nomenclature Amendment 1: Additional definitions".  The ventilator modes found in this standard mirror those published in "ISO 19223:2019 - Lung ventilators and related equipment — Vocabulary and semantics".  Annex I of the IEEE publication includes a high quality mapping between the IEEE and ISO terms.  

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