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"During the [pivotal] trial, the system made it possible for gastroenterologists to maintain minimal to moderate sedation with propofol, and helped prevent patients from entering deep sedation, which is traditionally associated with propofol," said Daniel Pambianco, MD, FACG, medical director of Charlottesville (Va.) Medical Research and trial investigator. "The system offers a way to personalize the level of sedation appropriate for each patient because it combines propofol delivery with sophisticated monitoring to help us better control and predict the patient’s sedation level."

Patients who received sedation with the SEDASYS System experienced fewer and less significant oxygen desaturation events, a clinical sign of over sedation, than patients sedated with current standard of care. The trial demonstrated this by achieving its primary endpoint of "area under the curve" (AUC) of oxygen desaturation (SpO2 < 90%). AUC is an objective measure of a patient’s respiratory status that incorporates incidence, duration and depth of oxygen desaturation. Patients in the SEDASYS System group had an average AUC value of one-third less than the current-standard-of-care patients. No device-related adverse events occurred in patients sedated with the SEDASYS System.

SEDASYS System patients were minimally-to-moderately sedated with propofol during the study. Sedation level was assessed every two minutes using a Modified Observer’s Assessment of Alertness/Sedation (MOAA/S) scale of 0-5. Patients who are minimally sedated respond readily when called by name (MOAA/S=5), while moderately sedated patients may require mild tactile stimulus to respond (MOAA/S=2-4). More than 99 percent of SEDASYS System patient responses were a MOAA/S score of 2 to 5, indicating minimal to moderate sedation, which had the added benefit of providing patients with faster recovery: Patients recovered from sedation almost two times faster with the SEDASYS System, and approximately 99 percent of SEDASYS System patients recovered within 10 minutes.

“On average, patients recovered from sedation in just 19 seconds, and this rapid patient recovery may have contributed to the high satisfaction scores,” in the feasibility study says Dr. Pambianco. The results of that study on CAPS have now been published in Gastrointestinal Endoscopy; the acceptance of these results by a peer-reviewed journal indicates the quality of the data and outcomes. Authors of "An assessment of computer-assisted personalized sedation: a sedation delivery system to administer propofol for gastrointestinal endoscopy" (found in the September issue) found that both clinicians and patients were highly satisfied with the outcomes. All procedures were successfully completed, and no device-related adverse events were reported.

"Patients understand that recovery from sedation takes time after a colonoscopy, but with propofol, they recuperate quicker and are functional sooner,” said Dr. Pambianco. “GIs have been performing procedures with current standard of care sedatives for years and maintaining a constant sedation level in patients can be daunting. The novelty of this system is that it has the potential to accurately tune into my patient’s sedation needs by following their vital signs and delivering propofol in a precise manner."

An anesthesiologist originally conceived the concept of CAPS, and multi-disciplinary advisory boards comprised of anesthesiologists, gastroenterologists, GI nurses and others have guided development of the technology. In March, Ethicon Endo-Surgery submitted a PreMarket Approval application, which included the pivotal trial results, to the FDA for approval of the SEDASYS System. Pending favorable FDA review, the SEDASYS System will be the first CAPS system available to physician/nurse teams for the administration of propofol during colonoscopies and EGDs. Learn more about Ethicon Endo-Surgery.