ROC - PART
Pragmatic Airway Resuscitation Trial
Enrollment began on March 29th, 2016
Oregon Health & Science University is part of a multi-site NIH funded prehospital study designed to determine if either of two airway management strategies currently used in the management of out-of-hospital cardiac arrest is better than the other. Cardiac arrest is defined as a severe malfunction or cessation of the electrical and mechanical activity of the heart. The heart essentially stops beating, blood does not circulate and a pulse cannot be felt. Cardiac arrest results in almost instantaneous loss of consciousness and collapse.
The two airway tubes being compared are 1) the "endotracheal tube (ET)," which is a plastic breathing tube inserted into the trachea (windpipe) to guide air into the lungs, and 2) a "laryngeal tube (LT)", which is a tube inserted into the esophagus (the opening to the throat and stomach, where you swallow), to block off the esophagus so that air only goes into the lungs. Of note, both types of tubes are approved by the FDA and are not considered investigational devices, but previous observational studies have not been able to show whether one works better than the other.
How will the treatment be given?
Participating Emergency Medical Services (EMS) agencies will carry sealed packages containing the airway device they are to use. As life-saving interventions are performed, the EMS provider will assess the patient and determine if they are eligible. Eligible patients will receive one of two treatments:
- Intubation (opening the airway) with an endotracheal tube (ET) - a flexible plastic breathing tube that is inserted between the vocal cords and into the trachea.
- Intubation with an LT (laryngeal tube) - a plastic tube that is inserted into the esophagus (the opening to the stomach) to block the esophagus so that air may only go through the trachea, or windpipe.
If the EMS personnel are not successful at inserting the tube that they are assigned to be used by the study, they will have the option to use the other method. Currently in the community both ET and LT is permitted, but the choice of which to use is left to the responding providers. During the study, the responders will be asked to use one of the two airway types as their first option.
Where will the study be conducted?
The study will be conducted in five locations across the United States, including the Portland Metro area and in Skamania County, WA. EMS personnel for Clackamas County Fire District #1, Hillsboro Fire Department, Lake Oswego Fire Department, MetroWest Ambulance, Skamania County EMS, and Tualatin Valley Fire and Rescue will be trained and participate in this study.
Normally, before someone joins a research study, it is discussed with him or her in detail. Also, a consent form that lists the purposes of the study, the possible benefits, and the risks from being in the study is reviewed with the person. If the person agrees to join the study, the consent form is signed. In most cases, this takes place before any study procedures are done or treatment is given. This process is called "informed consent" and ensures that the person volunteered for the research study only after being given the information necessary to make an informed decision.
For this study, investigators will not be able to get written informed consent from each study participant, due to them having a life threatening event. Instead, the investigators will try to inform the community about the study and address any concerns or questions before the study is approved to begin per the exception from informed consent federal rule. We will do this through:
- Website (www.ohsu.edu/emergency/roc/part)
- Community meetings
- Letters to community leaders, Neighborhood associations, and city officials
- Online and mailed surveys (take the online survey)
- Newspapers and Newsletters
Individuals who do not wish to participate in this study in the event of a cardiac arrest will be provided the option to request an opt-out bracelet. EMS providers will be trained to look for these bracelets on all cardiac arrest patients. The study is expected to enroll patients at 5 participating US ROC sites (Alabama, Dallas, Milwaukee, Pittsburgh, and Portland Metro/Skamania WA), for approximately 18 months.
If you still have questions after reviewing the website, please contact us via e-mail at firstname.lastname@example.org. (Note that the confidentiality of e-mail communications cannot be guaranteed) or at (503) 494-8083 where you will be able to leave a voice message. The e-mail and voice mails are checked regularly and you can expect to receive a reply within 3 days.