SETPOINT2 Quarterly Newsletter
May 2018
  • Study Update
  • SETPOINT2 Goals, Milestones & Recognition
  • Feature: "What's New in Tracheostomy: Science Review"
  • SETPOINT2 Mobil App
  • Upcoming Meetings & Dates

Study Update
March was a banner month for SETPOINT2, with 17 new enrollments at 9 sites our highest single-month enrollment total to date ; our thanks to those of you that contributed to this bonanza! March also saw activation and increasing utilization of the SETPOINT2 iPhone app, which helps calculate the SETscore and allows investigators to rapidly review enrollment criteria and access the randomizer. Our investigators should all have this useful tool uploaded onto their iPhones by now.

As you are likely aware, the SETPOINT2 data and safety monitoring board (DSMB) met in April and had no safety concerns with the trial - we have received their report and instruction to continue enrollment as planned. The next DSMB review will occur at 50% enrollment, which is coming up soon – perhaps by June of 2018.

SETPOINT2 has partnered with the Trial Innovation Network, a US-based and federally funded initiative of the National Center of Advancing Translational Sciences. Their mission is to provide consultative services to clinical trials – the collaboration is intended to improve our enrollment statistics to meet the PCORI benchmarks. We are quite close!

I offer a heartfelt thanks to our investigators, research staff, patients, families, stakeholders, and the Patient-Centered Outcomes Research Institute (PCORI) for their amazing support of the SETPOINT2 Trial.  Also, a clear mind, steady hands, and true vision in the New Year.

Please send your patients our way if they are interested in sharing their stories – we’re looking for family and survivor narratives to support this work, and to shed light on the family experience after severe stroke with respiratory failure.


Dave Seder, MD
Maine Medical Center Chief of Critical Care Services
Tufts University Associate Professor of Medicine
SETPOINT2 - US Principal Investigator

SETPOINT2 Goal Tracking
Congratulations & Great Work!

Charité University Medicine Berlin
 Berlin, Germany

Columbia Presbyterian Medical Center
New York, New York

Texas team pictured above - Principal Investigator: Dr. Jeremy Ragland, Research Coordinators: Elena, Glenda, Isabel, Angela, and Nina.
13 Patients Enrolled - Well Done!

Shout Out
The following centers had mutiple patient enrollments -Nice Work!
-Ohio State University (Columbus, Ohio)
-University of Texas Houston Health Sciences Center (Houston, Texas)
-Mayo Clinic Florida (Jacksonville, Florida)
-Maine Medical Center (Portland, Maine)

First Enrollments
OSF St. Francis Medical Center (Peoria, Illinois)
1st Enrollment: April 2018
Principal Investigator: Dr. Deepak Nair
Research Coordinator: Judi Beck

St. Jude Medical Center (Fullerton, California)
1st Enrollment: March 2018
Principal Investigator: Dr. Harry Peled
Research Coordinator: Natalie Valle

Email: for suggestions, questions and acknowledgements.

David Hwang, MD
Welcome to Dr. Hwang. He is the new Principal Site Investigator at Yale University School of Medicine. Dr. Hwang is an Assistant Professor in the Division of Neurocritical Care and Emergency Neurology at the Yale School of Medicine and and a neurointensivist at Yale-New Haven Hospital in Connecticut

Phani Kantamneni, MD
Welcome to Dr. Kantamneni. He is the new Principal Site Investigator at Kadlec Regional Medical Center. Dr. Kantamneni is a Critical Care (intensivists) specialist at Kadlec.
Pedro Salinas, MD
Thank you to Dr. Salinas for his previous work as the Principal Site Investigator at Kadlec Regional Medical Center.

Evie Marcolini, MD
Thank you to Dr. Marcolini for her previous work as the Principal Site Investigator at Yale University School of Medicine.
Feature Story: What's New in Tracheostomy
Science Review
By David Y. Hwang, MD, FAAN, FCCM, FNCS
Division of Neurocritical Care and Emergency Neurology, Yale School of Medicine

In planning SETPOINT2, the study’s principal investigators conducted a survey of members of the Neurocritical Care Society on their opinions regarding patients with severe stroke and tracheostomy. Among 143 respondents, 107 (74.8%) indicated that most of their patients with severe stroke undergo tracheostomy between day 6 and day 14.
To get a sense of whether this survey result actually matches up with practice patterns across the United States, a collaborative group of researchers at Yale and at the University of Rochester recently used a large database known as the National Inpatient Sample (NIS) to find out the average hospital day on which stroke patients who receive both a tracheostomy and feeding tube get their procedures done. The NIS is sponsored by the U.S. government for multiple purposes and contains information on approximately 1 in 5 of all patients discharged from U.S. community hospitals. 
The researchers first looked at all ischemic stroke and intracerebral hemorrhage (ICH) patients in the NIS from 2005-2014 who had been placed on a breathing machine during their admission. Then, they narrowed the list down to 7,771 patients who received both a tracheostomy and a feeding tube placed directly into the stomach through the abdominal wall. They found that on average these patients received their tracheostomy at 12.3 days, and their feeding tube at 13.5 days (with a high percentage on the same day).
While most patients in the study received their tracheostomy and feeding tube after day 7 in the hospital, a higher percentage of ICH patients in the study received both their tracheostomy and feeding tube early, by hospital day 7, compared to the ischemic stroke patients (19% vs. 15%). Overall, older patients (≥85 years) who had more medical problems before hospital admission and who had dysfunction of more than one organ in the hospital were more likely to have their tracheostomies and feeding tubes placed sometime after hospital day 7. 
The results of this study were presented as a brief oral presentation at the Society of Critical Care Medicine’s Critical Care Congress in San Antonio in February. This study does highlight the novel nature of the question that SETPOINT 2 is trying to answer. That is, it does not appear that most stroke patients on breathing machines in U.S. hospitals are already receiving tracheostomies within the first few days of being in the hospital.  
SETPOINT2 Partnering Centers
Location | Site Principal Investigator
Click on the map to see locations.
SETPOINT2 App Activated!
Site Principal Investigators, Research Coordinators, Project Managers if you are not using it, download this needed SETPOINT2 study information for your phone or tablet. The app is available for android and ios devices - go to the app or google play store and get it now!

"The SETPOINT2 app helped our team review the SETcore and eligibility criteria in a quick and convenient manner during our recent enrollment. "
~Natalie Valle, Program Coordinator St.Jude Medical Center, Fullerton, California

Take Note : Data Safety Monitoring Board Report was sent to all sites. Contact Barbara McCrum at mccrub@mmg if have not received it.
The Neurocritical Care Society's Annual Meeting is scheduled for September 25-28 at Boca Raton Resort & Club. For more information please see:
Upcoming Events

Maine Medical Center, Portland, ME

US RAC Meeting
Date: June 13, 2018
Location: Portland, Maine

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).