Anesthesiologist Survey Suggests Existing Pulse Oximetry Sensors Unreliable; Most Physicians Need Multiple Sensors in Surgery

IARS Respondents Report Difficulties in Getting Readings in up to 50% of Cases

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Assurance Biosense

May 28, 2013, 09:30 ET

GLASTONBURY, Conn., May 28, 2013 /PRNewswire/ -- A survey of anesthesia educators and investigators at the International Anesthesia Research Society (IARS) found that existing pulse oximetry sensors have significant limitations that hamper their reliability.

The survey found that fingertip sensors can be problematic:

  • Nearly one in five anesthesiologists (18.8 percent) say they "regularly" or "often" have problems getting an oxygen saturation reading due to ambient light interference.
  • More than half of anesthesiologists (53.2 percent) say they have trouble getting an oxygen saturation reading in up to half their cases.
  • Nearly 94 percent (93.8 percent) of anesthesiologists say they have had to try multiple pulse oximetry sensors during surgery to get a reading and nearly three in 10 (29.2 percent) said they do so "regularly" or "often".

"Pulse oximetry is a critical tool for patient safety, but the limitations of fingertip sensors compromise their effectiveness, putting patients at risk," said Andrew Kersey, President.  "Our preliminary survey of IARS participants clearly shows how fingertip sensors are a weak link in patient safety monitoring. We plan to expand this research over the coming months."

Assurance Biosense, a subsidiary of Xhale, Inc., unveiled its next-generation Assurance® Alar Sensor at the IARS meeting held in San Diego May 4-7, 2013. The meeting was attended by more than 1,000 of the world's leading anesthesia educators and investigators and focused on the latest advances in research and the best practices in anesthesia critical care.

The Assurance Alar Sensor, which recently received U.S. Food and Drug Administration (FDA) 510(k) clearance, monitors oxygen saturation of arterial hemoglobin (SpO2) and pulse rate from the nasal ala of adult and pediatric patients. The sensor measures blood flow at the nasal ala, the fleshy lateral part of the nares, and research has shown it to be more accurate and reliable than clip-on fingertip sensors. Moving the sensor from the hands to the ala may improve patient comfort and allows patients greater freedom of movement.

This site, unlike the fingertips, is far less prone to measurement failures in patients with cardiorespiratory comorbidities, who are hypotensive, receiving vasoactive drugs or are hypothermic or anxious.

Additionally, the sensor's design and placement makes it less prone to interference from ambient light, including sunlight, a common problem with fingertip sensors. Assurance Alar Sensors are compatible with a variety of monitors currently in the market, including all that use Nellcor OxiSmart II sensors.

"Our conversations with anesthesiologists showed there is widespread interest in new-generation sensors that are more accurate and reliable and provide greater protection for patients," said Richard J. Melker, M.D., Ph.D., CTO, Anesthesiology and Pediatrics at the University of Florida College of Medicine and co-founder of Xhale. "Participants at the IARS meeting expressed significant interest in our technology and we look forward to their using it to care for patients soon."

The Assurance® Alar Sensor improves patient safety because it detects signals accurately even at low oxygen saturation, senses changes in oxygenation sooner and overcomes shortcomings of existing fingertip sensors including a high rate of false alarms.

Pulse oximeters have become ubiquitous in hospitals for monitoring virtually all patients because they can give clinicians an early warning of low arterial blood oxygen saturation levels, known as hypoxemia.  Early detection is critical because hypoxemia can result in brain damage or death in a matter of minutes. 

The Assurance Alar Sensor is designed for the continuous non-invasive monitoring of SpO2 from the nasal ala of adult and pediatric patients (weighing >30kg).  The sensor fits to the nasal ala without adhesives and is easily checked or repositioned by the clinician as necessary, allowing it to remain on the patient for the full length of stay.

About Assurance Biosense:

Assurance Biosense, a wholly owned subsidiary of Xhale, Inc., is committed to providing clinicians with easy-to-use, cost-effective diagnostic solutions that improve patient safety and reduce false alarms.  Its Assurance® line of PPG/oximetry sensors are uniquely designed to monitor by placement on the nasal ala, a region rich in vasculature, fed by the external and internal carotid arteries which also supply the brain.  The unique physiology of the site provides a much stronger signal than that from a fingertip or extremity, delivering more robust pulse oximetry signals.  Measurement from this site will enable monitoring a range of critical physiologic parameters which cannot be monitored via conventional pulse oximetry.  www.assurancebio.com

About Xhale:

Xhale, Inc., is a medical technology innovator, developing products that transform healthcare and save lives.  The company is a world leader in the use of sensors that analyze vapor and exhaled breath and is focused on novel patient-centric monitoring solutions.  Its two current product lines include SMART®, the world's only definitive medication adherence monitoring system, and Assurance®, a single-point-of-contact sensor that monitors multiple patient parameters more comfortably and conveniently than finger-based pulse oximetry with fewer false alarms.

(Note:  Certain applications described above have not been reviewed by the FDA, and are therefore labeled for investigational use only.)

For more information, please visit www.Xhale.com or contact Investor Relations at the company at [email protected] or 352-371-8488.

 

SOURCE Assurance Biosense