SBIR-STTR Award

?"Code blue," the term used in hospitals to call for an immediate cardiopulmonary resuscitation (CPR), signals dire emergencies where medical errors can occur and lives can be lost. Reviewing CPR performance of the code blue team is a cornerstone for improving outcomes. Thorough and accurate recording of code blue events enable detailed reviews to promote quality improvement and patient safety. However, currently used handwritten records on "code sheets" are subject to human errors and lack details for measuring key quality indicators. Here, we will develop an electronic device for complete recording of code blue events. We call this device the "BlueBox". The BlueBox is a small patch to be placed on the chest when the resuscitation begins. It will capture all code blue events -- vital signs, cardiac rhythms, verbal orders and their execution, chest compressions, cardioversion/defibrillation, procedures, medications, and labs. Our goal for the BlueBox is to support staff training and hospital quality improvement, thus enhance the safety of patients undergoing CPR. We have 3 specific aims: (1) complete the engineering development of the BlueBox device; (2) implement the software user interface (UI) for the "electronic code sheet"; and (3) validate the BlueBox system in code blue simulations. The BlueBox device includes multiple sensors embedded on a micro-electronics platform. We will integrate all sensors-- ECGs, accelerometry, temperature, contact microphone, and voice recorder. We will prepare the firmware to enable simultaneous recording of all data, with time stamps. The enclosure will be designed to withstand pressures from chest compressions and voltages from cardioversion and defibrillation. We will develop an "electronic code sheet" UI to display the code blue events. An app will be developed for the iOS (iPads). The app will retrieve data from the BlueBox via Bluetooth Low Energy (BLE), then display code blue events chronologically, with time stamps. The UI will enable reviews of all recordings, voice playbacks, zooms (to 1 sec intervals), user annotations, and analysis of key CPR quality indicators. The user can export the electronic code sheet as a portable document format (pdf) file, for printing a conventional paper medical record or uploading to hospital electronic medical records (EMRs). For BlueBox validation, we will test the system in 20 "mock code" sessions held in the Harbor- UCLA Simulation Center. Voice recordings from BlueBox will be compared to video recordings. We will also test the BlueBox device on 6 male pigs in CPRs conducted by a 4-person code blue team. We will troubleshoot and improve the BlueBox system until >90% accuracy and not false indicators are achieved. The project is significant, because it is expected to improve medical practice and patient safety in the hospital. It represents a novel and innovative way of recording and analyzing the critical data from code blue resuscitations to support staff training and quality improvement.

Public Health Relevance Statement:


Public Health Relevance:
Debriefings and detailed reviews of the performance of the "code blue team" in cardiopulmonary resuscitation (CPR) can improve quality of care and patient outcomes. We will develop an electronic device, the BlueBox, for recording all CPR events, to enable full displays of code blue resuscitations. The device will support medical training and quality improvement in code blue situations, so that the safety of patients undergoing CPR in hospitals can be improved.

NIH Spending Category:
Bioengineering; Cardiovascular; Emergency Care; Patient Safety

Project Terms:
Animals; Cardiac; Cardiopulmonary Resuscitation; Chest; Clinical Trials; Code; Code Blue; commercialization; Computer software; Computerized Medical Record; Data; design; Development; Devices; Disclosure; Electric Countershock; Electrocardiogram; Electronics; Emergency Situation; Engineering; Event; Family suidae; file format; Funding; Goals; Handwriting; heart rhythm; Hospitals; Human; improved; innovation; Left; male; Marketing; Measurement; Measures; Medical; Medical Errors; Medical Records; Monitor; monitoring device; novel; Outcome; Paper; patient safety; Patients; Performance; Persons; Pharmaceutical Preparations; Phase; Physicians; pressure; Printing; Procedures; Process; public health relevance; Quality Indicator; Quality of Care; Records; Research Training; respiratory; Respondent; Resuscitation; Security; Security Measures; sensor; Signal Transduction; simulation; Small Business Technology Transfer Research; Sternum; success; Surface; Surveys; System; Temperature; Testing; Time; tool; Training; Validation; Video Recording; Voice; voltage

“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 a clinical study of code blues in the hospital. We will first conduct a pilot study of 5 code blue patients in the CCU and Cath Lab. Once the pilot study is successful, we plan to conduct a full clinical study of 100 patients recruited from the Harbor-UCLA ICU/CCU and emergency departments. 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. 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.

Public Health Relevance Statement:
PROJECT NARRATIVE 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.

Project Terms:
Accident and Emergency department; Adhesives; American Heart Association; Animals; base; Cardiac; Cardiopulmonary Resuscitation; care outcomes; Chest; Clinical; Clinical Research; Code; Code Blue; commercialization; Computer software; Data; Data Analytics; design; Development; Devices; Documentation; Effectiveness; Electric Countershock; Electronics; Emergency Situation; Engineering; Event; Family suidae; Feedback; Generations; Goals; Guidelines; heart rhythm; Hospital Administrators; Hospitals; Human; human error; improved; improved outcome; Industrialization; Left; Machine Learning; machine learning algorithm; Manikins; Measurement; Mechanics; Medical; Medical Errors; meetings; member; Miniaturization; mobile application; Modeling; Outcome; Paper; Patient Recruitments; patient safety; Patient-Focused Outcomes; Patients; Performance; Pharmaceutical Preparations; Phase; Pilot Projects; Preparation; Procedures; Process; product development; Production; prototype; Quality Indicator; Quality of Care; Records; respiratory; Resuscitation; Running; sensor; Signal Transduction; simulation; Small Business Technology Transfer Research; Specialist; Specific qualifier value; Sternum; System; Technology; technology development; Testing; Time; tool; Training; usability; validation studies; Validity and Reliability