Researchers at the Medical College of Wisconsin (MCW) will conduct a research study to evaluate two types of airway tubes that are currently used by Emergency Medical Services (EMS) to treat patients with out-of-hospital cardiac arrest. These airway tubes are used to keep the patient’s airway open in order to deliver oxygen. Both types of airway tubes are approved by the US food and Drug Administration (FDA), but previous research has not shown whether one type of airway tube is better than the other.
Firefighters and paramedics are among the first medically-trained responders on scene after a patient suffers an out-of-hospital cardiac arrest. MCW researchers will be working with the firefighters and paramedics of Milwaukee County EMS in order to conduct this study. These EMS providers will determine if a patient is eligible to take part in the study. Patients who have been enrolled in this study will receive one of two types of airway tubes – an “endotracheal tube” or a “laryngeal tube”. These patients will get all other standard-of-care treatments for cardiac arrest.
Because this study will be conducted on people who have suffered cardiac arrest and are unconscious, permission to take part in this study is not likely to be obtained before the patient is enrolled. Because of this, the MCW Institutional Review Board that oversees all clinical studies has granted the study an exception from informed consent for emergency research allowing the paramedics to enroll the patient as outlined by the Food and Drug Administration. Study leaders have conducted community consultation surveys to determine the community is supportive of the research.
Opting out of this study:
Anyone who does not wish to be enrolled in this study may opt-out by wearing an opt-out bracelet or necklace. Milwaukee County EMS providers are trained to not enroll anyone who is wearing this bracelet or necklace. An opt-out bracelet or necklace may be requested free of charge by either calling the Resuscitation Research Center at (414) 805-6493 or email at RRC@mcw.edu. Patients who choose not to participate in this study will receive all of the standard care deemed necessary by paramedics.
In addition to Milwaukee County, this study is also being conducted in Birmingham, Alabama; Dallas, Texas; Pittsburg, Pennsylvania; and Portland, Oregon.
For more information on exception from informed consent under emergency circumstances, risks and benefits, opt-out bracelets, or details of the study, call Dr. M. Riccardo Colella, associate professor of emergency medicine at MCW at (414) 805-6493 or email RRC@mcw.edu, or visit the web site at www.mcw.edu/ROCPART.
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