SETPOINT2 Quarterly Newsletter
May 2019
  • Study Update
  • SETPOINT2 Goals, Milestones & Recognition
  • Feature Story: SP2 Up-close by Dr. David Seder
  • SETPOINT2 News

Study Update

As of March 31, SETPOINT2 study reached 77% enrollment - thanks to all study sites for diligently working to achieve this milestone. We are also in the process of completing our study extension with the Patient-Centered Outcomes Research Institute (PCORI). We are excited to begin this next phase which will allow the study to continue thru February 2020 with six month follow ups completed by August 2020.

Site Principal Investigators and Research Coordinators, don't forget to utilize the SETPOINT2 study app. You can download needed SETPOINT2 study information to your phone or tablet. The app is available for android and ios devices. According to Natalie Valle, Program Coordinator at St.Jude Medical Center, Fullerton, California, "the SETPOINT2 App helped our team review the SETscore and eligibility criteria in a quick and convenient manner during our recent enrollment."

Thank you to our investigators, research staff, patients, families, stakeholders, and PCORI for their continued support of the SETPOINT2 Trial. 

Best regards,
Julian & Dave
Julian B ö sel, MD
Overall Study Principal Investigator
David, Seder, MD
US Principal Investigator

SETPOINT2 Goal Tracking
University of Maryland: Top US Site for Enrollments!
PI: Dr. Nick Morris & RC: Stephanie Sanchez

OSF St. Francis Medical Center: Multiple Enrollments
PI: Dr. Deepak Nair & RC: Judi Beck

University of Heidelberg: Top German Site for Enrollments!
PI: Dr. Silvia Sch önenberger, MD & RC: Perdita Beck
Feature Story: SP2 Up-close by Dr. Seder

Hello to the SETPOINT2 Family!

As a group, we’ve recently passed the major milestone of being 75% enrolled toward study completion , and we’ve officially entered into the last quarter of patient enrollment. I wanted to take a few moments to reflect on the study from the point-of-view of being a local Principle Investigator in Maine, where we have enrolled 30 patients, and become quite comfortable with the study protocol, the SETscore, and the overall flow and operational elements of early and delayed tracheostomy.

As an investigator, I love SETPOINT2 . I have enough time to approach families after the initial shock of the stroke has abated, and at a time when they can truly consider the pros and cons of study participation. It’s an opportunity for true informed consent. It’s also an opportunity to create another connection with family members, who can become proactive members of the treatment team, instead of the passive recipients of care. Many of them are grateful for the opportunity to participate, and also to contribute to science, helping “improve the outcomes of future patients with the same problem”. After they consent, I give them a newsletter and my contact information, and I encourage them to reach out to me down the road. I have never once regretted doing so.

I believe the procedure is absolutely safe to do in the early window. When we trach, we typically monitor ICP (increased intracranial pressure) and ETCO (end-tidal carbon dioxide), and minimize the duration of bronchoscope-in-the-airway to prevent a rise in CO 2 and ICP. Most patients are trached with the bed flat but in “reverse trendeleburg” ie., head in elevated position at 20-30 degrees, which is easy to do and prevents ICP rise. External ventricular drains (EVDs) can be opened to drain cerebrospinal fluid (CSF) mid-procedure if the ICP goes up. And if I have no ICP monitor but the brain looks a little tight, we sometimes give a dose of prophylactic mannitol an hour before the procedure. Using these “tricks” we have not had any ICP or hemodynamic problems, and no complications. The procedures always go smoothly.

I tremendously look forward to Research Advisory Committee meetings!  This is our stakeholder advisory group, made up of family members, stroke survivors, nurses, clergy, administrators, stroke advocacy group members, physicians, therapists, and others. Over dinner, we present updates about the study, discuss issues with enrollment, consenting, communication, and other challenges, and let our committee discuss issues of importance to stroke survivors and the healthcare system. Invariably, I learn something critically important, or many important things, and I like the feeling of camaraderie. One of our longstanding RAC members travels 10 hours to participate in these meetings – that is the sense of value and connection they create. It is an honor to participate, and I expect to continue meeting with the RAC group even after the trial is completed. They will become a stakeholder advisory group for stroke care, ongoing.

Thanks to all of you for being such a great “Family” . As a study administrator, I appreciate all the efforts you make day after day to connect with your patients and families, and to contribute to our scientific mission of improving stroke outcomes – you are an amazing group, and I’m lucky to know you all.

Maine Medical Center, Portland, Maine, USA

Dr. David Seder (second from left) is picture with a former patient and his healthcare team.

SETPOINT2 Partnering Centers

Click on the map to see locations.

RAC Meetings
The next German Research Advisory Committee (RAC) meeting is scheduled for late summer and the next US July 30, 2019.
Planning is underway for a SETPOINT2 investigator meeting with US and German Investigators during the NCS Annual Meeting (October 15-18). Learn more about the NCS Annual Meeting at:

In Case you Missed it!

This video is another tool to use with potential study participants and their families to help explain the SETPOINT2 Study. A big thank you to Dan Good for producing the video, Sara Schrock for the voiceover, and Barbara McCrum, Project Manager Maine Medical Center. Click on the video to view or go to:
Want to contribute information to the newsletter? We'd love to hear from you. Please email us at: 

Visit the SETPOINT2 website for in-depth information for patients, families and investigators.

Research reported in this newsletter was funded through a Patient-Centered Outcomes Research Institute (PCORI) Award (CER-1602-34137).