Breathing Tube Position and Patency Monitoring System
Department of Health and Human Services
Agency Tracking Number:
Solicitation Topic Code:
Small Business Information
SONARMED, INC., 5513 West 74th Street, Indianapolis, IN, 46268
Socially and Economically Disadvantaged:
AbstractDESCRIPTION (provided by applicant): This project will evaluate the clinical efficacy and cost savings benefits from use of an endotracheal tube (ETT) position and patency monitoring system through a prospective, randomized, controlled trial conducted at multiple clinical centers. The two years, two phase study will enroll up to 270 subjects that include neonates, children, and adults who require intubation for extended ventilatory assistance. The system operation is based on an acoustic pulse-echo technique that non-invasively probes ETTs with sound and uses the returning echoes to determine the tube's position within the patient and provide quantitative information regarding tube patency. Phase I will verify safety and feasibility in approximately 50 subjects by programming the device to continuously collect ETT position and function data while the subject is mechanically ventilated, but blinding the research team to these data. Normal "standard of care" procedures will be used to maintain proper ETT function (e.g. routine chest x-rays to confirm ETT position, suctioning). Measurable results from these procedures will be compared to the data recorded on the device to determine consistency. Adverse events will be analyzed to determine if any were device related. If the results meet the safety and feasibility endpoints, Phase II will be initiated. Phase II will consist of a prospective, 1:1 randomized study of approximately 220 subjects in which the device will be used as a primary means to monitoring ETT location and function. Device data will be collected in addition to the standard of care measures performed on each subject. The primary hypothesis being investigated in this study is that use of this device will decrease the overall respiratory adverse event rate associated with mechanical ventilation. Secondarily, the data will be analyzed to determine if this device reduces adverse events associated with ETT position or function and predicts ETT-related adverse events prior to their occurrence. SonarMed's intelligent endotracheal tube (ETT) monitoring system has the potential to establish a new paradigm in the standard of care for airway management. It will enable clinicians to move from the current reactive approach that provides corrective action only in response to indirect indications of ETT complications (patient in respiratory distress), towards a more proactive methodology where immediate notification of high risk ETT conditions (ETT on verge of extubation) can be used to anticipate and thereby prevent adverse events.
* information listed above is at the time of submission.