FOR IMMEDIATE RELEASE
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Project Funded by the Patient-Centered Outcomes Research Institute
PORTLAND, Maine – Maine Medical Center (MMC) has been awarded $2.5 million by the Patient-Centered Outcomes Research Institute (PCORI) to study whether early tracheostomy in severely ill stroke patients who require mechanical ventilation improves survival, recovery and the patient and family experience.
A tracheostomy is a temporary surgical airway that provides a more comfortable alternative for delivering oxygen to the lungs when a stroke patient’s breathing has failed.
The research study will be led by David Seder, M.D., Director of the medical center’s Neurocritical Care team and a principal investigator at the Maine Medical Center Research Institute.
Prior studies have suggested that when patients whose breathing has failed after a severe stroke undergo tracheostomy early in the course of their recovery, the risks of pneumonia and other complications that can lead to a prolonged hospital stay and death are lower.
However, the common practice in many hospitals is to delay the tracheostomy procedure for up to three weeks, in case the patient recovers airway protective reflexes.
This PCORI-funded study seeks to definitively demonstrate the benefits of early tracheostomy by combining the experience of an international consortium of 20 hospitals.
“This research study tests whether a reversible tracheostomy in patients with respiratory failure after stroke, performed earlier than is currently standard practice, results in shorter duration of coma, earlier rehab activities, shorter duration of mechanical ventilation, improved survival and improved long-term functional outcomes,” said Dr. Seder. “If successful, the trial could change the way such patients are treated worldwide, and has the potential to dramatically improve the outcomes of the sickest stroke patients.”
He continued, “The study will also assess other potential benefits of the early intervention such as a shortened duration of coma, improved patient comfort and a better ability to communicate with the patient.”
Dr. Seder and his collaborator, Dr. Julian Bösel, at the University of Heidelberg, Germany, will spearhead the project and oversee its efficacy and safety along with colleagues at 20 hospitals across the U.S. and Germany.
The study, called SETPOINT2: A Pragmatic Trial to Test the Effectiveness of Early vs. Delayed Percutaneous Tracheostomy in Patients with Severe Stroke and Respiratory Failure, is a collaboration between MMC, the University of Heidelberg and the Neurocritical Care Society Research Network (NCSRN).
Dr. Seder is partnering with the Maine Medical Center Research Institute (MMCRI) and MMC’s Neuroscience Institute on the study. PCORI also considers patients, families, and other key stakeholders to be key collaborators in the research process. The US SETPOINT2 research advisory committee will include MMC Chaplain Alice Hildebrandt, MMC stroke survivor family member Danielle Phinney, a representative of the American Heart Association/American Stroke Association and several others.
“Maine Medical Center and its Research Institute are proud to be named as the U.S. coordinating center for the $2.5 million SETPOINT 2 clinical trial. This multi-site, international research project is designed to test the most effective method of providing respiratory support to critically ill stroke patients in an intensive care unit setting,” said Donald St. Germain, M.D., Vice President, Research, MMC and Director, MMCRI. “The results of this project will define a critically important set of standards to guide the care of severely ill stroke patients. It represents the dedicated efforts of highly skilled critical care teams around the world and the commitment and support of MMC, its collaborating institutions and PCORI to provide the best care possible for patients suffering from stroke.”
Dr. Seder’s award has been approved pending completion of a business and programmatic review by PCORI staff and issuance of a formal award contract. “This project was selected for PCORI funding not only for its scientific merit and commitment to engaging patients and other stakeholders, but also for its potential to fill an important gap in our health knowledge and give people information to help them weigh the effectiveness of their care options,” said PCORI Executive Director Joe Selby, M.D., MPH. “We look forward to following the study’s progress and working with Maine Medical Center to share the results.”
PCORI is an independent, nonprofit organization authorized by Congress in 2010. Its mission is to fund research that will provide patients, their caregivers, and clinicians with the evidence-based information needed to make better-informed healthcare decisions. For more information about PCORI’s funding, visit pcori.org.
About Maine Medical Center
Maine Medical Center (MMC), recognized as the number‐one ranked hospital in Maine by U.S. News and World Report for 2016‐2017, is a complete health care resource for the people of Greater Portland and the entire state, as well as northern New England. Incorporated in 1868, MMC is the state’s largest medical center, licensed for 637 beds and employing nearly 6,500 people. MMC's unique role as both a community hospital and a referral center requires an unparalleled depth and breadth of services, including an active educational program and a world‐class biomedical research center. As a nonprofit institution, Maine Medical Center provides nearly 23 percent of all the charity care delivered in Maine. MMC is a member of the MaineHealth system, a growing family of health care services in northern New England. For more information, visit www.mmc.org.
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