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
2
(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.
Dave Seder MD, FCCP, FCCM, FNCS, FAHA
Maine Medical Center, Portland, Maine, USA
