Sedation system to raise compliance?
Diagnostic procedures range from easy and unobtrusive (maybe just a quick nasal swab, that's all), to highly obtrusive and uncomfortable (read, colonoscopy), with this spectrum largely determining patient willingness to pursue them.
The result for colonoscopy: Many keep putting off this procedure or avoid it altogether.
The answer to this problem is improved comfort, perhaps through improved sedation, with something better than the current use of a painkilling bolus or opioid injection, according to Mike Gustafson, executive director of Ethicon Endo-Surgery in Cincinnati.
Gustafson said the necessary improvement is on deck, with the company's recent filing of an application to the Food and Drug Administration (FDA) for pre-market approval of its SEDASYS system. SEDASYS is billed as "the first computer-assisted personal sedation (CAPS) system," primarily targeting colonoscopy but also esophageal procedures or other such diagnostics with fairly high discomfort levels for the patient. Rather than simply offering sedation more flexibly, when needed, the system provides continuous monitoring of vital signs of the depth of sedation. Perhaps more importantly, from a patient compliance point of view, Ethicon Endo-Surgery is seeking regulatory labeling for the SEDASYS that enables its use by a physician or nurse and not requiring the presence of an anesthesiologist, thus greatly expanding its potential uptake by providers and acceptance by patients.
Demonstrating a sensitivity to overclaiming for a product not yet approved, Gustafson didn't tout a variety of claims for SEDASYS, but said: "What I can tell you is that our feasibility studies in the U.S. and Belgium demonstrated that [SEDASYS] is able to deliver very precise and personalized delivery of propofol [Diprivan] by the nurse or physician."
Propofol is the sedative drug to be used with the system, with the company emphasizing the system's provision of only "minimal to moderate" sedation in the targeted procedures.
The company's submission includes results from a multicenter randomized trial of 1,000 patients that compared the safety/effectiveness of the SEDASYS to current sedation used in routine endoscopic procedures: physician-administered benzodiazepine and opioids. The study assessed safety based on Area Under the Curve (AUC) for oxygen desaturation, reflecting objective measurements incorporating incidence, duration, and depth of oxygen desaturation and the risk for oversedation.
The trial found SEDASYS effective based on level of sedation, sedation recovery time, and clinician and patient satisfaction, without the aid of an anesthesia professional.
Gustafson said the concept "was originally the idea of an anesthesiologist, and we have had a number of marvelous anesthesiologists actively involved" in development.
He emphasized the system's ability to provide monitoring of the patient throughout the procedure. Tethered to the patient via IV, the system tracks seven physiology parameters, from blood pressure to respiratory activity and providing continuous data via what the company calls "a novel automated response monitor."
Additionally, the system provides for verbal prompting of the patient through an earpiece, to monitor responses via the patients' ability to respond to these prompts (for instance, asking the patient to take a deep breath). With any signs of oversedation, the system can be shut down, or it can sense oversedation and "proactively takes action, stops or reduces the delivery," Gustafson said.
"One of our focuses has been real practice and we've engaged human factor experts [in the development process]," he says. "We feel really good about SEDASYS from a human factor perspective."
Along this same line of thinking, the company will be developing a specific training program and protocols for system use as the product is under FDA review.
Without providing firm expectations, Gustafson didn't argue with a possible approval by the FDA later this year and product rollout in 2009, calling that possible timeline "reasonable." He said Ethicon Endo-Surgery has put nine years and a "significant amount of resources" — though declining to disclose the specific dollar amount — into SEDASYS development.
Price studies, Gustafson reported, are ongoing.
"It's all about the early detection and treatment of colon cancer," he said. Compliance with that type testing, he noted, is unacceptably low, at a rate of 20% to 25%, with the company hoping that use of the SEDASYS could push this to as high as 75%.
While Gustafson said that the company is hoping that standard anesthesia codes will cover use of the SEDASYS, he asserted, "There is no technology like this today."
Diagnostic procedures range from easy and unobtrusive (maybe just a quick nasal swab, that's all), to highly obtrusive and uncomfortable (read, colonoscopy), with this spectrum largely determining patient willingness to pursue them.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
- Award-winning Medical Content
- Latest Advances & Development in Medicine
- Unbiased Content