69 - See for Yourself: A Methodology for the Care of Patients with Age-related Macular Degeneration on a Phase I/iia Trial
“How do perioperative professionals plan for a ‘First-In-Human’ procedure?” This is a question frequently asked by perioperative staff at the National Institutes of Health (NIH). As the nation’s largest hospital devoted exclusively to clinical research, patients at the NIH Clinical Center often require treatments that have never been performed on human research participants. In 2018, the National Eye Institute (NEI) began the review process for a Phase I/IIa Trial to investigate the autologous transplantation of induced pluripotent stem cell-derived retinal pigment epithelium (iPSC-RPE) for geographic atrophy associated with age-related macular degeneration (AMD). This protocol will require research participants to undergo transplantation of iPSC-RPE into their subretinal space under operating room conditions. Using this trial as a model, the authors present a methodology for the intraoperative care of patients undergoing an experimental procedure that is the first of its kind.
The first step in planning for this procedure is dependent on the Principal Investigator (PI) obtaining approval from the proper authorities. Once the trial is approved by the Food and Drug Administration (FDA) and cleared by the NIH Internal Review Board (IRB), the PI will provide an in-service that addresses the entire perioperative team to educate staff members about the disease, including its symptoms and current treatments. The operative plan will be described in detail, including all critical steps, anesthesia requirements, as well as necessary instrumentation and supplies. Postoperative considerations will also be discussed. The next step is team selection. The PI will request a team member from each professional role in the care of the patient and generally includes at a minimum an anesthesiologist, the service-specialist RN, and a surgical technologist with experience in the required specialty. Discussions between the PI, the research RN and the team members will occur as needed prior to the date of the first planned procedure.
Prior to the first surgery, the team may practice the procedure in its entirety on an animal model in an off-site location. This practice suite is supplied with equipment and instrumentation that are identical to those used in the main operating room, providing team members the opportunity to gain familiarity with the procedure without posing any risk to the human research participants.
On the day of the first surgery, team members will verify that all necessary medications and supplies are available, and that the correct implant is available and on site. Additional checks will be completed at Pre-Op huddle and during the OR time out.
The methodology presented in this poster can be adapted for use with other new procedures. This poster also provides a window into the process of starting a new clinical trial from the perioperative perspective, as well as the unique challenges that intraoperative personnel encounter at the NIH Clinical Center.
Co-Authors: Phuong Tong Nguyen, Jessica Turner, Richard Balta, Valeria Hoang