May 19, 2008 – Portland OR –
Study will be conducted by paramedics at the scene of a person's collapse
Oregon Health & Science University, along with local emergency medical services and health system partners, is beginning a study in the Portland/Vancouver metropolitan area that will test methods of resuscitating people who experience cardiac arrest outside of the hospital. People eligible for this study will be unconscious as a result of the cardiac arrest and therefore unable to provide consent. The study will be conducted under Food and Drug Administration (FDA) guidelines that allow research in certain life-threatening situations without pretreatment authorization.Cardiovascular disease is the most common cause of death in the United States and Canada. More than 350,000 people die every year from cardiac arrest in North America. About half of these people have shown no prior symptoms of heart disease, and only about 5 percent will survive.
“Outcomes for cardiac arrest patients have not significantly improved in more than 30 years," said Mohamud Daya, M.D., lead study investigator of ROC PRIMED and associate professor of emergency medicine in the OHSU School of Medicine. “The ROC PRIMED study will look at two resuscitation strategies that have shown considerable promise in smaller trials.”
The first line of treatment in the ROC PRIMED study will look at the use of CPR before delivering an electrical shock to restart the heart of someone experiencing an abnormal heart rhythm, which often is associated with cardiac arrest (ventricular fibrillation). Smaller studies have shown that a sustained amount of CPR before shocking the heart may lead to increased blood flow and improved outcomes, though for many years the standard treatment has been to immediately shock the heart. Subjects in the ROC PRIMED study will randomly receive either about 30 seconds of CPR or three minutes of CPR before having their heart rhythm checked to determine if an electrical shock is needed.The other treatment in the ROC PRIMED study is an impedance threshold device (ITD). This small, plastic device, about the size of a fist, fits onto the facemask or breathing tube used during cardiopulmonary resuscitation (CPR). The ITD may provide increased blood flow back to the heart during the decompression phase of CPR, allowing more blood to circulate during the compression phase. People eligible for the study will randomly receive either CPR with the actual device or CPR with a device that looks identical to the ITD, but does nothing. Neither the paramedics nor the study investigators will know which one the person receives.
OHSU ROC investigators spent six months reaching out to the community to inform them of the risks and benefits of the proposed study. They sent information to elected officials, neighborhood associations, community groups and minority organizations throughout the affected, four-county metropolitan area. They gave presentations to a diverse group of community organizations and held a focus group as well as reached out to local media. The study has also been reviewed and approved by local Institutional Review Boards (IRBs) to ensure the safety of people enrolled in the study.The ROC PRIMED study will exclude anyone with a known preference for refusing lifesaving treatment, such as a Physicians Orders for Life Sustaining Treatment (POLST) form or other advance directives, women with an obvious pregnancy or people under arrest at the time of the attack. The study will only enroll people ages 18 and older, though the expected median age of enrollees is older than 60.
EMS agencies and hospitals in Multnomah, Clackamas, Washington and Clark counties will work together to conduct this important research. Locally, ROC investigators hope to enroll about 600 people annually in the ROC PRIMED study.
The ROC PRIMED study is one of a series of federally funded studies known as the Resuscitation Outcomes Consortium (ROC). Portland was designated a ROC community by the National Institutes of Health in 2004. The consortium comprises 10 regional medical centers across the United States and Canada that seek to find promising scientific and clinical advances to improve survival from cardiac arrest and severe trauma. The ROC consortium plans to conduct multiple studies during the course of several years, testing new or alternative drugs, tools and techniques. The first ROC study, testing different kinds of saline for reviving trauma patients has enrolled more than 100 people in the Portland area since the end of 2006.
EMS agencies across North America currently use slightly varying methods to treat patients. ROC investigators would like to determine the best methods for treating victims of cardiac arrest and severe trauma. The best way to do this is to get the treatment to victims as quickly as possible, which means at the site of the incident. The ROC consortium allows studies to be conducted simultaneously in multiple locations, both urban and rural, thus taking less time to complete, and allowing results to more quickly guide future practice.
People who wish to exclude themselves from the study will be given a bracelet similar to a medical alert bracelet. EMS professionals in the four counties are trained to look for these bracelets and will not enroll these individuals in this or any other ROC study. To request an opt-out bracelet, people should call 503 494-7014.
Oregon Health & Science University is the state's only health and research university, and Oregon's only academic health center. OHSU is Portland's largest employer and the fourth largest in Oregon (excluding government), with 12,400 employees. OHSU’s size contributes to its ability to provide many services and community support activities not found anywhere else in the state. It serves patients from every corner of the state, and is a conduit for learning for more than 3,400 students and trainees. OHSU is the source of more than 200 community outreach programs that bring health and education services to every county in the state.