COMPACT MEDICAL INC. — Department of Health and Human Services STTR Phase I: NICHD

Description

PROJECT SUMMARY Bag-valve-mask (BVM) resuscitators are difficult to use correctly and are commonly misused, even by trained medical personnel. Misuse can result in serious injury and death due to volutrauma or barotrauma, and this is particularly concerning when resuscitating pediatric patients, in whom there is an extreme range in lung volume. Traditional BVMs provide no adequate means of restricting the volume of air delivered when the bag is squeezed, so medical personnel rely on their ability to monitor chest rise to determine whether they are delivering an appropriate volume. Chest rise can be especially difficult to monitor in pediatric patients under emergency conditions, when simultaneous monitoring of peak inspiratory pressure (by observing a manometer) and other patient parameters is required. Similarly, the rate at which breaths are delivered is not regulated by traditional BVMs, and medical personnel often exceed safe rates. Compact Medical, Inc. is developing a safer, easy-to- use device, the Butterfly BVM resuscitator, that restricts the ventilation volume, rate, and pressure to safe levels that can be quickly set according to the patient. The device’s “concertina” design allows easier compression with one hand, leaving the other hand free to maintain the seal between the mask and the patient’s airway. In a study with end-users at Indiana University Simulation Center, a fully functional prototype will be tested to validate its safety features versus a traditional BVM for pediatric applications and to gather user feedback. Aim 1 is designed to test the ability of the Butterfly BVM to promote guideline-consistent patient care by users who have had a minimal introduction to the device. Sixty participants trained in pediatric emergency resuscitation (physicians, respiratory therapists, and emergency medical technicians; 20 per group) will receive a minimal introduction to the Butterfly BVM and perform a series of resuscitation tasks using the Butterfly BVM and a traditional BVM under conditions designed to replicate high-stress pediatric emergency resuscitation scenarios (mock codes). The tasks will be performed on a mannequin system that collects air volume, breath rate, and pressure data. Aim 2 is designed to determine whether the users can learn with a brief introduction how to manipulate the settings of the device to fit predetermined clinical scenarios. Following the mock codes in Aim 1, the participants will be shown a brief instructional video fully introducing the Butterfly BVM and its operation and given 5 minutes to familiarize themselves with the device before engaging in another series of mock codes that require the Butterfly BVM’s settings to be modified. The participants’ abilities to correctly manipulate the Butterfly BVM’s settings will be recorded, and a questionnaire will be administered to gather user perceptions and feedback. Project milestones include consistent restriction of minute ventilation and pressures to AHA-recommended levels, significant reductions in standard deviations for minute ventilation and peak pressure vs. a traditional BVM, and 75% user preference for and correct use of the Butterfly BVM for pediatric resuscitation.PROJECT NARRATIVE Traditional bag-valve-mask (BVM) resuscitators are often misused by medical personnel, delivering volumes, pressures, and ventilation rates that exceed established safety guidelines and can result in serious injury to patients, especially children, in whom lung volume varies widely. This project is a clinical simulation study to test the ability of trained medical personnel to deliver guideline-compliant resuscitation in realistic pediatric clinical scenarios using Compact Medical, Inc.’s Butterfly BVM prototype vs. a traditional BVM and to gather usability data and feedback. The novel, adjustable Butterfly BVM device is designed to restrict the ventilation volume, rate, and pressure to safe levels that can be quickly set to meet the needs of a range of pediatric patients, including infants, thereby reducing the risk of resuscitation-related injury.