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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: $723,986.00
Phase: Phase II
Program: STTR
Solicitation Topic Code: 400
Solicitation Number: PA18-575
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
DUNS: 079424567
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 (310) 866-0709
Business Contact
Phone: (310) 866-0709
Research Institution
IRVINE, CA, 92617-3213
 Nonprofit college or university
Code blueis the signal used in hospitals to call for an immediate cardiopulmonary resuscitationCPRfollowing a cardiac or respiratory arrestReviewing the performance of thecode blue teamis a cornerstone for improving outcomesThe current standard of using handwritten records on a papercode sheetdoes not allow measurement of key quality indicators and is subject to human errorIn the Phase I STTR projectwe developed an electronic device for complete recording of code blue eventscalled BlueBoxThe BlueBox is a small electronic recorder on an adhesive patch to be placed on the left chest next to the mid sternumThe prototype we developed in Phase I was successfully tested on high fidelity mannequins and on pigsIn Phase IIour goal is to complete the product development and testing and prepare the BlueBox for regulatory clearance and market launchTo achieve this goalwe proposeSpecific AimsAimis to complete the product development of the BlueBox device and the software user interfaceUIfor theelectronic code sheetWe will turn the engineering prototype we developed in Phase I into a product ready for commercialization through rigorous product development processesWe will develop a mobile app for iPads with a software UI for theelectronic code sheetAimis to conduct human factors and usability engineeringHF UEtesting and prepare for regulatory submissionThe alpha prototype will undergo HF UE testing in the Simulation CenterWe will establish and maintain quality management records and conduct a pilot production run ofunits of BlueBoxAimis to validate the BlueBox system in a clinical study of code blues in the hospitalWe will first conduct a pilot study ofcode blue patients in the CCU and Cath LabOnce the pilot study is successfulwe plan to conduct a full clinical study ofpatients recruited from the Harbor UCLA ICU CCU and emergency departmentsThe objectives of the clinical study areto establish equivalence of the electronic code sheet to the current standard of paper code sheetto demonstrate the effectiveness of the electronic code sheet in identifying key CPR quality indicatorsThe 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 recordingThere will be two major milestones in this projectfinalizing product development with successful test production ofunitsandcompleting the clinical study and preparing for aksubmissionAchieving the aims will result in a validated BlueBox system ready for submission to the FDA and commercializationWe intend to first introduce the BlueBox system to hospitals as a tool for staff training and quality improvementWe will continue the technology development with machine learning to provide instant feedback in the second generation BlueBoxOur ultimate goal is to minimize human error and improve patient outcomes through the BlueBox systemandapos s better documentation and continuous feedback mechanism PROJECT NARRATIVE Debriefings and detailed reviews of the performance of thecode blue teamin cardiopulmonary resuscitationCPRcan improve quality of care and patient outcomesIn Phase Iwe developed and successfully tested an electronic devicethe BlueBoxfor recording all CPR events and enabling full displays of code blue resuscitations in anelectronic code sheetWe 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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