Collection and analysis of vital signs

Inventors

Reifman, JaquesKhitrov, Maxim Y.Reisner, Andrew T.Chen, LiangyouMcKenna, Thomas

Assignees

United States Department of the Army

Publication Number

US-9697468-B2

Publication Date

2017-07-04

Expiration Date

2031-08-06

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Abstract

A system is disclosed having a storage, a communications module for interacting with a medical measurement device, an analysis controller, and a test module that allows for the testing and evaluating of decision-support algorithms. A method for testing decision-support algorithms is disclosed having the steps of receiving into storage of a ruggedized, compact computer at least one decision-support algorithm; detecting with a communications module the initiation of a vital-sign monitoring session; receiving and storing vital-sign information into storage by the communications module; pushing the stored vital-sign information by an analysis controller to a test module running the stored at least one decision-support algorithm; and providing at least one output from the decision-support algorithm to at least one of a database and a display.

Core Innovation

The invention provides a system and method for developing, testing, and evaluating decision-support algorithms in a portable unit using stored data and/or real-life, real-time data. It includes components such as a storage, a communications module for interfacing with medical measurement devices, an analysis controller that monitors the storage for new data, a reliability module for assessing data quality, and a test module that runs decision-support algorithms on the stored data. The system is ruggedized and compact, enabling operation in settings away from established medical facilities, and is capable of real-time processing of continuous streams of vital-sign information received from external vital-sign monitors.

The disclosed method involves receiving at least one decision-support algorithm into the storage of a ruggedized, compact computer, detecting the initiation of a vital-sign monitoring session via the communications module, receiving and storing vital-sign information, determining whether the vital-sign information is quality data, pushing quality data to the test module where the algorithm is run, and providing outputs from the algorithm to a database, display, or external device. The system and method facilitate the testing and evaluation of new decision-support algorithms in a portable environment, enabling real-time analysis and refinement.

The problem addressed lies in the proprietary nature of decision-support algorithms embedded in vital-sign monitors provided by manufacturers, which limits the ability of end-users or manufacturers to easily modify, refine, or test new decision-support algorithms. Existing research typically relies on retrospective analysis of previously gathered data on workstations or servers, lacking portability, real-time processing, and end-user flexibility. The invention aims to overcome these limitations by enabling the testing and evaluation of decision-support algorithms in a compact, ruggedized device that operates in real time and supports easy modification and refinement.

Claims Coverage

The patent claims focus on methods for testing decision-support algorithms incorporating vital-sign data processing, quality assessment, and real-time operation within a ruggedized, compact computing system. There are multiple inventive features across the independent claims.

Receiving and storing decision-support algorithms and vital-sign information in a ruggedized, compact computer

The method includes receiving at least one decision-support algorithm into storage of a ruggedized, compact computer, and receiving and storing vital-sign information from an external vital-sign monitor into that storage, where the vital-sign information is associated with a vital-sign monitoring session and includes vital signs.

Determining quality of vital-sign information based on agreement between different vital signs

The method determines whether the vital-sign information is quality data when there is agreement between two different vital-signs within the vital signs; if the data is not quality, then it is not used by the system.

Pushing quality vital-sign information processed into constant-frequency vectors to a test module running decision-support algorithms

The analysis controller pushes stored quality vital-sign information to a test module running the stored decision-support algorithm by retrieving the data from storage and converting it into multiple constant-frequency row vectors, which accounts for missing data by shifting data accordingly.

Real-time determination and processing of vital-sign data

The system determines in substantially real-time from receipt of vital-sign information whether the data is quality, excluding non-quality data from processing, thereby enabling immediate analysis and output during monitoring sessions.

Detecting initiation and termination of vital-sign monitoring sessions based on vital-sign thresholds and signals

The communications module detects the initiation of a vital-sign monitoring session based on vital-sign values exceeding predetermined thresholds or receipt of start signals, and determines session termination based on vital-sign values below thresholds or signals representing session end.

Utilizing a reliability module to assess data quality through mathematical analysis and cross-vital-sign agreement

A reliability module reviews vital-sign data to determine its accuracy by mathematical analysis including curve fits, waveform rhythmicity, and agreement between different vital-signs or sensors, thereby informing the test module about which data is reliable for decision-support algorithm processing.

Overall, the claimed invention covers a ruggedized, compact system and method that receives, stores, and processes vital-sign information in real time, includes mechanisms for assessing data quality via a reliability module, converts data into consistent formats for algorithm processing, detects sessions, and outputs decision-support algorithm results to storage or display, thereby enabling flexible testing and evaluation of such algorithms.

Stated Advantages

Enables real-time processing and analysis of vital-sign data with minimal lag time, enhancing timely clinical decision support.

Provides a portable, ruggedized, and compact system operable in field settings away from established medical facilities, improving flexibility and accessibility.

Facilitates easy modification, refinement, and updating of decision-support algorithms by loading them into the storage, overcoming the proprietary limitations of existing systems.

Includes a reliability module that automatically assesses the quality and reliability of vital-sign data, ensuring algorithms operate on accurate and clean data streams.

Supports session-based data organization, enabling archival, transfer, or wireless transmission of data for further analysis or clinical use.

Documented Applications

Testing and evaluating decision-support algorithms for processing vital-sign data from medical monitoring devices.

Real-time monitoring and analysis of vital signs such as heart rate, respiratory rate, blood oxygen saturation (SpO2), and blood pressures.

Use in ambulances, medical evacuation helicopters, and other field environments where portable and rugged vital-sign analysis is necessary.

Archiving and transferring patient vital-sign data to medical facilities for further clinical evaluation or continuous monitoring.

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