The cNEP Airway System reduced respiratory impairment in patients undergoing mild to moderate sedation by 45%.
San Diego, CA, May 10, 2016 /PRWeb/ — Sommetrics™, Inc., a company focused on providing products and services that improve the quality of sleep, today announced the publication of study results demonstrating that the company’s cNEP® Airway System significantly reduces respiratory impairment during screening colonoscopy. The peer-reviewed study results were published online in the journal Endoscopy, a leading GI endoscopy journal. The cNEP Airway System is FDA cleared as an aid for maintaining the patency of the upper airway in spontaneously breathing adults undergoing medical procedures less than two hours in duration, where the patient is intended to have mild to moderate sedation with non-propofol containing medications.
The 54-patient study described in the publication was designed to assess the effectiveness of the cNEP Airway System in reducing the frequency of sedation-induced respiratory impairment, defined as either a decline in oxygen saturation or apneic events lasting 20 seconds or more, during screening colonoscopy. The first 24 patients underwent standard sedation and monitoring, while the next 30 patients, in addition to standard care, received cNEP. The research was conducted at the Division of Gastroenterology and Hepatology at Scripps Green Hospital and Scripps Clinic Torrey Pines in La Jolla.
The study found that sedation-induced respiratory impairment was reduced by 45% with the cNEP Airway System, a statistically significant difference. Additionally, the use of the cNEP Airway System was associated with a marked reduction in apneic events and the need for supplemental oxygen.
• 92% reduction in obstructive apneas ≥ 20 seconds
• 82% fewer patients experienced an obstructive apneic event
• 76% fewer patients required supplemental oxygen
• No safety issues associated with cNEP were identified in this study
Anesthesia administered during medical procedures may cause the upper airway to become more vulnerable to collapse, which can result in cessation of breathing (apnea). These apneic events may often go unnoticed, and can lead to a drop in oxygen saturation requiring clinical intervention. The cNEP Airway System helps avoid airway collapse by delivering continuous negative external pressure (cNEP) via a soft collar that is applied over the front of the neck overlying the upper airway. The system is non-invasive and can easily be applied by healthcare professionals of all skill levels.
“These broad and consistent effects indicate that cNEP can be an effective method for preventing respiratory compromise due to airway obstruction associated with the use of sedatives and opiate analgesics for endoscopic procedures,” said Kenneth Klein, M.D., a study investigator. “With the cNEP Airway System, clinicians now have a simple, hands-free tool to help maintain an open airway. This may help reduce patient complications.”
“We are very pleased to have the results of the cNEP Airway study available to the clinical community as evidence of the product’s efficacy,” said. Richard Rose, M.D., CEO and Chairman of Sommetrics. “This study adds to a growing base of information that supports both the safety and effectiveness of cNEP in keeping the airway open in the acute care setting as well as in common conditions which disrupt sleep like obstructive sleep apnea and chronic snoring.”
Sommetrics develops products and services for assessing and managing sleep problems associated with the narrowing of the upper airway. These problems range from obstructive sleep apnea to snoring and other disruptive sleep patterns that affect a large number of adults worldwide. Sommetrics’ proprietary technology, cNEP (continuous negative external pressure), provides a comfortable way of keeping the airway open during sleep and mild to moderate sedation. The Company’s first product, the cNEP Airway System, gained FDA clearance in December 2015. For more information, visit www.Sommetrics.com.
cNEP is a registered trademark of Sommetrics, Inc. Sommetrics is a trademark of Sommetrics, Inc.
Richard M. Rose, M.D.
President and CEO