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BlueBox: A Complete Code Blue Data Recorder, Phase II

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 2R42GM113463-02
Agency Tracking Number: R42GM113463
Amount: $1,545,479.00
Phase: Phase II
Program: STTR
Solicitation Topic Code: 400
Solicitation Number: PA18-575
Timeline
Solicitation Year: 2018
Award Year: 2019
Award Start Date (Proposal Award Date): 2019-02-01
Award End Date (Contract End Date): 2021-01-31
Small Business Information
2605 INDIAN CREEK RD
Diamond Bar, CA 91765-3356
United States
DUNS: 079424567
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: Yes
Principal Investigator
 RUEYKANG CHANG
 (424) 558-3500
 neovative@yahoo.com
Business Contact
 RUEYKANG CHANG
Phone: (424) 558-3500
Email: neovative@yahoo.com
Research Institution
 UNIVERSITY OF CALIFORNIA-IRVINE
 
141 INNOVATION DRIVE, SUITE 250
IRVINE, CA 92617-3213
United States

 Nonprofit college or university
Abstract

“Code blue” is the signal used in hospitals to call for an immediate cardiopulmonary resuscitation (CPR) following a cardiac or respiratory arrest. Reviewing the performance of the “code blue team” is a cornerstone for improving outcomes. The current standard of using handwritten records on a paper “code sheet” does not allow measurement of key quality indicators and is subject to human error. In the Phase I STTR project, we developed an electronic device for complete recording of code blue events, called BlueBox. The BlueBox is a small electronic recorder on an adhesive patch to be placed on the left chest next to the mid-sternum. The prototype we developed in Phase I was successfully tested on high fidelity mannequins and on pigs. In Phase II, our goal is to complete the product development and testing and prepare the BlueBox for regulatory clearance and market launch. To achieve this goal, we propose 3 Specific Aims. Aim 1 is to complete the product development of the BlueBox device and the software user interface (UI) for the “electronic code sheet.” We will turn the engineering prototype we developed in Phase I into a product ready for commercialization through rigorous product development processes. We will develop a mobile app for iPads with a software UI for the “electronic code sheet.” Aim 2 is to conduct human factors and usability engineering (HF/UE) testing and prepare for regulatory submission. The alpha prototype will undergo HF/UE testing in the Simulation Center. We will establish and maintain quality management records and conduct a pilot production run of 200 units of BlueBox. Aim 3 is to validate the BlueBox system in clinical studies. The objectives of the clinical study are: 1) to establish equivalence of the electronic code sheet to the current standard of paper code sheet; 2) to demonstrate the effectiveness of the electronic code sheet in identifying key CPR quality indicators. We will conduct a code blue simulation study of 50 sessions on high fidelity mannequins with hospital code blue teams to compare BlueBox recording with paper code sheets. We will conduct a study of 30 healthy volunteers for BlueBox sensor validation. The criteria for successful development of the product will be that it passes all required regulatory testing and is validated in the clinical study for its equivalence and effectiveness in code blue recording. There will be two major milestones in this project: (1) finalizing product development with successful test production of 200 units; and (2) completing the clinical study and preparing for a 510(k) submission. Achieving the aims will result in a validated BlueBox system ready for submission to the FDA and commercialization. We intend to first introduce the BlueBox system to hospitals as a tool for staff training and quality improvement. We will continue the technology development with machine learning to provide instant feedback in the second generation BlueBox. Our ultimate goal is to minimize human error and improve patient outcomes through the BlueBox system’s better documentation and continuous feedback mechanism.
Modified Specific Aims“Code blue” is the alert used in hospitals to initiate immediate cardiopulmonary resuscitation (CPR) following a cardiac or respiratory arrest.1 These situations are dire emergencies. Medical errors are likely to occur, and lives can be lost. Reviewing the performance quality of the “code blue team” is a cornerstone for improving outcomes of in-hospital arrests.2-4 Thorough and accurate recording of code blue events facilitates the detailed analyses needed for quality improvement.5-7 However, the current standard of using handwritten records on a paper “code sheet” does not allow measurement of key quality indicators and is subject to human errors.
In our Phase I STTR project, we developed an electronic device for complete recording of code blue events, called BlueBox. The BlueBox is a small electronic recorder on an adhesive patch to be placed on the left chest next to the mid-sternum. It captures and records all code blue events -- vital signs, cardiac rhythm, verbal orders and their execution, chest compressions, cardioversion/defibrillation, procedures, medications, and labs. The prototype we developed in Phase I was successfully tested on high fidelity mannequins in the Simulation Center, and on pigs in the Animal Lab. The purpose of the BlueBox is to support medical training and quality improvement in code blue situations, and to enhance safety for patients undergoing CPR.
In Phase II, our goal is to complete the product development and testing to prepare the BlueBox for regulatory clearance and market launch. To achieve this goal, we propose 3 Specific Aims:
Specific Aim 1. Completing the product development of the BlueBox recorder and the software user interface (UI) for the “electronic code sheet”
In Phase I, after developing the BlueBox technology and completing its proof-of-concept, the engineering prototype was tested successfully. The firmware drives all sensors and enables simultaneous recordings of all parameters with time stamps. The circuit can withstand 5kV, which is what is used in cardioversion and defibrillation. In Phase II, we will turn the prototype into a product ready for commercialization through rigorous product development processes. The product development processes include: miniaturization, mechanical design, industrial design, and usability engineering, as well as development of a mobile app for an iPad with an “electronic code sheet” user interface (UI) displaying the code blue events. To provide instant feedback during CPR, we will develop model-based and machine learning data analytics during and beyond the Phase II project.
Specific Aim 2. Conducting human factors and usability testing, quality management and regulatory support and preparation
We will conduct human factors and usability engineering (HF/UE) testing on the alpha prototype in the Simulation Center. The first HF/UE study aims to test the use of the BlueBox recorder by members and captains of the hospital code team in a code blue scenario. The second HF/UE study aims to test the software and UI of the electronic code sheet on iPads, as used by members of the hospital code blue team, hospital administrators, and EMR and IT specialists. We will establish and maintain quality management records and conduct a pilot production run of 200 units of BlueBox. The pilot run units will be tested for reliability and validity in the Simulation Center. We will request a pre-submission meeting (Qsub) with the FDA. In the Qsub meeting, we will discuss specific regulatory submission requirements and obtain feedback on the clinical validation study.
Specific Aim 3. Validating the BlueBox system in clinical studies
We will first conduct a prospective study of 50 sessions of simulated code blue resuscitations. Each session will be attended by a team of 4 clinicians-- a captain (physician), a nurse, an ancillary staff, and a code sheet recording staff (typically a nurse). We will also conduct a study of BlueBox sensor validation in 30 healthy volunteers. We will conduct a code blue simulation study on high fidelity mannequins with a hospital code blue team to compare BlueBox recording with paper code sheets. The objectives of the clinical studies are: 1) to establish equivalence of the electronic code sheet to the current standard of paper code sheet; 2) to demonstrate the effectiveness of the electronic code sheet in identifying key CPR quality indicators specified in the American Heart Association (AHA) guidelines.
Feasibility Criteria: The criteria for successful development of the BlueBox are:1) it passes all required regulatory testing; 2) it is validated in the clinical study for its equivalence and effectiveness in code blue recording and quality review and improvement.
Expected Outcomes and Impact: Two major milestones are (1) finalizing product development in Year 1, and (2) completing the clinical study in Year 2. Achieving the aims will result in a validated BlueBox system ready for regulatory submission to the FDA and commercialization. We intend to first market the BlueBox system to hospitals as a tool for staff training and quality improvement. We will continue the development of BlueBox technology with machine learning algorithms to provide instant feedback. Our ultimate goal is to minimize human error and improve patient outcomes through the BlueBox system’s continuous feedback mechanism.Debriefings and detailed reviews of the performance of the “code blue team” in cardiopulmonary resuscitation
(CPR) can improve quality of care and patient outcomes. In Phase I, we developed and successfully tested an
electronic device, the BlueBox, for recording all CPR events and enabling full displays of code blue resuscitations in an “electronic code sheet.” We will turn the engineering prototype into a product ready for regulatory submission and commercialization in the proposed Phase II project.

* Information listed above is at the time of submission. *

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