The Oxalert EPO in Post-Operative Patients
The Oxalert uses a patented patient notification method very similar to the"enhanced" notifications used in the study at OHSU, (Oregon Health Science University) in 2011 (References):
In this small Proof-of-Concept study, 10 patients wearing headphones recovering from surgery in the Post-Anesthesia Care Unit were monitored, as usual, by continuous pulse oximetry. If SpO2 dropped below 90% for too long a message through the headphones asked them to "Take a deep breath". If the SpO2 failed to rise above 90%, "annoying" electrical shocks were delivered through electrodes on the hand.
The SpO2 (oxygen saturation) dropped too low 125 times in these 10 patients--after patients fell back to sleep, often their SpO2 once again dropped below 90%.
In all 125 cases (100%), either the audible command alone or a combination of the command to breathe and stimulation was followed by the SpO2 going back above 90%. The method tested was more successful than nurses shaking patients by the arm and shoulder asking them to breathe (PACU nurses care for only 1 or 2 patients at a time and are usually nearby).
"Importantly, this trial did confirm the potential utility of the device for preventing oxygen desaturation in postoperative patients at risk for respiratory depression".
--Pre-submission comment from FDA reviewers in 2017
The level of stimulations used in the Oxalert is user-adjustable, and at maximum is less than what can be delivered by FDA-approved nerve stimulators.
Would any of the patients studied dropping below 90% have died, had heart attacks or strokes had they been left alone by both the device or the nurses? Nobody knows. But continuous pulse oximetry is the Standard of Care in the PACU, the ER and the ICU if opioids have been given. Exceptions are most patients on post-op hospital floors, and of course, those using opioids at home.
A Dartmouth study of 2100 patients who had continuous pulse oximetry and nurse notifications by a pager-system (References) showed 59% fewer "Unexpected ICU Transfers" and "Rapid Response Team/"Code Blue" events. There were no reported deaths over a several year period.
Will the Oxalert be similarly successful or decrease deaths, heart attacks or strokes? We are not making that claim until it is proven in a clinical study. The Dartmouth study was convincing.
Continuous respiratory monitoring with pulse oximetry for post-op patients
using respiratory depressants is long overdue and would raise the Standard of Care on hospital floors. Patients using the Oxalert Enhanced Pulse Oximeter will more likely avoid hypoxemia and associated negative outcomes.