Clinical Evaluation of a Rebreathing Adsorber Mask to Facilitate Recovery from Vo
Agency: Department of Health and Human Services
Agency Tracking Number: GM083405
Phase: Phase I
Awards Year: 2008
Solicitation Year: 2008
Solicitation Topic Code: N/A
Solicitation Number: PHS2007-2
Small Business Information
AXON MEDICAL, INC.
3487 W. 2100 South, Suite 100, SALT LAKE CITY, UT, 84119
HUBZone Owned: Y
Woman Owned: Y
Socially and Economically Disadvantaged: Y
Phone: () -
Phone: (801) 484-3820
AbstractDESCRIPTION (provided by applicant): After surgery patients are transferred to a post anesthesia care unit to fully recover from anesthesia. There is a much higher chance of an adverse clinical event occurring during this recovery time (24%) than in the op erating room because patients are not as closely monitored. Airway obstruction is the most frequent complication. Patients with a critical respiratory event stay longer in the care unit, have higher rates of unanticipated admission to an intensive care uni t and are more likely to have cardiac problems. We propose to develop and test a charcoal filled rebreathing mask that accelerates the rate of removal of anesthetic vapors and shortens anesthesia recovery time. Patients will more quickly regain normal cogn itive function, homodynamic normalcy and reflexes to allow for airway protection from secretions and obstruction. They will more quickly gain a sense of well being resulting in earlier discharge from the post anesthesia care unit. We will test a prototype device with a lung/gas exchange simulator and conduct a clinical trial with 44 patients, measuring their rate of recovery and the incidence of critical events during the first 24 hours after surgery. If successful, the charcoal filled rebreathing mask has the potential to shorten the patients stay in the post anesthesia care unit by 20 min and reduce the risk of a critical event occurring by 60%. PUBLIC HEALTH RELEVANCE: Use of the rebreathing mask to speed recovery after anesthesia could potentially reduce the overall cost of each of the 20 million general anesthetic procedures performed in the United States each year. Reducing the recover time by 20 min might decrease the cost of a patient's stay in the PACU by 110 and reduce the risk of post anesthesia c ritical events by 60%.
* information listed above is at the time of submission.