ISAP Statement

ISAP Continues Endorsement of the Moderate Sedation Training Program for Computer-Assisted Personalized Sedation (CAPS) System

On May 3, 2013, Sedasys, a Division of Ethicon Endo-Surgery, Inc. (Ethicon), announced that the U.S. Food and Drug Administration (FDA) has granted premarket approval for the SEDASYS® System, the first Computer-Assisted Personalized Sedation (CAPS) System. This System provides moderate sedation for ASA physical status I and II patients, 18 years old undergoing colonoscopy and esophagogastroduodenoscopy (EGD) procedures.

Consistent with its mission of fostering and encouraging research, education, and scientific progress in anaesthetic pharmacology, the International Society for Anaesthetic Pharmacology (ISAP) is pleased to continue to provide independent third party development oversight and endorsement of moderate sedation and airway management training for non-anesthesia professionals who administer propofol using a CAPS system. ISAP recognizes the important safety features of CAPS that guide propofol administration to avoid deeper-than-intended sedation, detect ventilatory depression and unresponsiveness, and stop propofol administration when appropriate, but also recognizes the need to provide in depth moderate sedation training to sedation practitioners that will administer propofol using a CAPS system.

The SEDASYS System label states that:

The SEDASYS® System should be used by a physician-led team trained in administering moderate sedation and trained in the management of under and oversedation. At a minimum, the member of the physician-led team who is administering sedation must have training in the management of the cardiorespiratory effects of propofol when administered using computer-assisted personalized sedation systems. The training must include:

  • Pharmacology of propofol.
  • Identification of high risk patients.
  • Recognition of progression of levels of sedation, and actions necessary to return a patient to intended levels of sedation.
  • Use of capnometry and the determination of adequate ventilation.
  • Management of airway obstruction and hypoventilation.

More information on the SEDASYS® System can be found at www.sedasys.com. The sedation training ISAP is endorses is intended to be generically applicable to CAPS but is not connected to a specific device. The device manufacturer provides the device training for CAPS.

ISAP partnered with Applied Medical Visualizations (Medvis), a medical educational software and simulation company with a history of excellence in sedation training, to develop training for propofol moderate sedation using CAPS. The course, entitled Safe Sedation Training (SST), includes on-line knowledge base training, rescue skill set training using high fidelity simulation, and propofol-specific training.

The on-line course can be accessed at www.safesedationtraining.com.

The simulation training (SSTsim) consists of 5 scenarios that focus on recognizing and managing deeper-than-intended sedation (from propofol and other sedatives), airway obstruction, and ventilatory depression. The course provides a summative assessment similar to an ACLS course using checklists of core competencies; students repeat the scenarios until mastering the competencies.

The ISAP board of directors maintains a five-member Moderate Sedation Oversight Committee to provide on-going review of the content and participant evaluations.

By December 2014, over 50 participants completed the training (SST + SSTsim) and the Committee was provided a summary of the course evaluations. As of August 2013 all physician users of the SEDASYS® System have completed the required training. There are >35 physicians and nurses using the SEDASYS System today. The number of patients sedated with the System is estimated to be over 2,000 as of this update.

The Committee does not endorse the training for physician led non-anesthesia sedation practitioners to administer propofol without a CAPS system or to administer propofol to achieve deep sedation or general anesthesia as the targeted sedation states. The Committee recognizes that in addition to moderate sedation and airway management training, practitioners will require device specific training (provided by the manufacturer) to implement CAPS. It is also assumes practitioners have basic medical knowledge commensurate with their professional training, licensure and moderate sedation privileges.

Course Description

The moderate sedation knowledge base training is an on-line course developed by Medvis and approved by ISAP. A preliminary version of the course was reported at the 2011 Annual Meeting of the American Society of Anesthesiologists (Runnels et al: A Web-based, Interactive, ³Virtual Preceptorship² Moderate Sedation Training Program for Non-Anesthesiologists; Abstract 169). The course content is based on best practices and guideline statements put forward by professional societies including the American Society of Anesthesiologists. The 4 to 6 hour course contains 9 modules and focuses on the knowledge base necessary for the safe and effective practice of moderate sedation in adult patients. It provides a formative assessment of learner understanding using interactive questions.

The rescue skill set training is a high fidelity simulation based course developed by Medvis and approved by ISAP. A preliminary version of the training (without propofol related content) was described in a peer-reviewed manuscript over 10 years ago (Farnsworth et al: Teaching sedation and analgesia with simulation. J Clin Monit 2000;16:273-285).

The propofol training, is integrated into the knowledge base and rescue skill set courses and provides the propofol-specific knowledge base and rescue skill training mandated by the inclusion of propofol to the sedation formulary. These propofol related enhancements include content addressing propofol¹s basic and clinical pharmacology, pharmacokinetics and pharmacodynamics, dosing guidelines, opioid interactions, adverse effects, and concerns in special populations. The course elements that address propofol are only provided to CAPS customers at this time.

For more information related to this, please contact the Chair of the Moderate Sedation Oversight Committee, Mohamed Naguib, MD.