?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.
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.