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What is the purpose of this study?
The purpose of this study is to determine whether one of two airway tubes that are currently being used in the prehospital setting is better than the other, when used in cardiac arrest victims. The two tubes being compared are 1) the “endotracheal tube,” which is a plastic breathing tube inserted into the airway (windpipe), and 2) a “laryngeal tube”, 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. Both types of tubes are used by Emergency Medical Service (EMS) providers, but previous studies have not shown whether one works better than the other. Also, both types of tubes are approved by the FDA and are not investigational devices.
Out-of-Hospital Cardiac Arrest is a major public health problem. This condition affects over 300,000 adults in the United States each year. Despite organized international efforts, only about 1 in 10 people survive after an out-of-hospital cardiac arrest (OCHA).
Treatment for cardiac arrest must be initiated quickly to limit the extent of injury.  Successful resuscitation from OCHA requires delivery of life-saving oxygen to injured organs such as the heart and brain. Airway management is the process of opening the mouth and throat to deliver oxygen to the lungs. There are several methods of opening the airway, but not one of these has proven to be more effective than the others when used by EMS providers.  More research must be done to guide treatment for this common, disabling and potentially lethal health problem. 

Who will be included in the study?
Patients who suffer an out-of-hospital cardiac arrest and meet the eligibility criteria may be enrolled in this study. Eligibility criteria describe patient characteristics that are required to be included in the study as well as characteristics that would exclude the patient from the study.

nclusion Criteria (subjects must meet ALL of the following):

a)     Out-of-hospital cardiac arrest (OHCA);
b)     Adult (age 19 years or older);
c)     Non-traumatic cause of cardiac arrest;
d)     Requiring ventilatory support (indicated by EMS use of bag-valve-mask device).
The trial will include EMS-witnessed arrests. The trial will include individuals experiencing more than one OHCA during the same care episode.
If a patient receives bag-valve-mask ventilation but intubation, the patient will be included in the study per intention-to-treat principles, regardless of whether the patient regains consciousness or remains unconscious.

Exclusion Criteria (this study will exclude the following subjects):
Protected Populations
a)      Known pregnant women;
b)      Known prisoners;

c)      Major facial trauma (visible major deformity, excessive bleeding from the mouth, etc);
d)      Major bleeding or bleeding that cannot be controlled (e.g., major upper or lower GI bleed, visceral perforation, major uncontrolled bleeding from laceration or injury);

Pre-Existing Conditions or Prior Treatment
e)      Patient receiving initial care by a non-PART participating EMS agency capable of performing ETI, LT or other advanced airway management;
f)       Patients with ET tube, LT or other advanced airway device inserted prior to participating EMS agency arrival (e.g., non-ROC EMS agency or healthcare facility personnel);
g)      Patients with a pre-existing tracheostomy;
h)     Obvious asphyxial cardiac arrest (e.g., choking, foreign body aspiration, angioedema, epiglottitis, trauma to mouth and face, etc.);
i)       Patients with a left ventricular assist device (LVAD) or total artificial heart (TAH);
j)        Patients with pre-existing written “do-not-attempt-resuscitation” (DNAR) orders;
k)      Inter-facility transports;

Other Exclusions
l)       Patients with a “do not enroll” bracelet.

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 three treatments: 
1.     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.
2.    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.

3.    If the responding EMS personnel have not been trained in the use of these devices, basic bag-valve-mask will be utilized.
If the EMS personnel are not successful at inserting the tube that is being used by the study, they will use another method instead.

Where will the study be conducted? 
The study will be conducted in six locations across the United States, including central Alabama.  EMS personnel for Bessemer Fire Department and Birmingham Fire and Rescue, and Regional Paramedical Services in Walker and St. Clair counties will be trained and participate in this study.

How many patients will be enrolled in the study? 
A total of 3,000 patients will be enrolled across all participating ROC sites in the United States. In Alabama we anticipate almost 1000 people will be enrolled in this study.

When will the study start? 
The first patient is expected to be enrolled in the summer of 2015. The start time will be different at each of the ROC sites depending on when they receive approval to begin the study.

How long will it take to complete the study? 
The study enrollment is expected to last approximately four years once all sites have begun enrolling.

How do patients enroll in the study?
Patients in this study will have had a cardiac arrest. Cardiac arrests occur unexpectedly, and because of the inability to predict when a cardiac arrest is going to occur, a person cannot sign up ahead of time.  Patients will almost always be unconscious (unable to speak or hear) when they are enrolled in the PART trial.  Life-supporting interventions must be given immediately in the field by the EMS personnel (Paramedics or EMTs – Emergency Medical Technicians).  Patients are too sick to consent to immediate treatment.  Therefore, the EMS personnel will enroll patients with a cardiac arrest into the study by opening a package and using the airway device that is in the kit. 

How can research be done on a person without the person’s permission?
There are serious medical emergency situations where patients are unconscious or too sick to give permission to be enrolled in a study.  Cardiac arrest is one of those situations.  The PART study will be conducted under federal regulations that allow an exception from informed consent (EFIC).

What is exception from informed consent?
In 1996, the Food and Drug Administration (FDA) developed specific regulations to permit emergency research without prospective consent under carefully controlled circumstances.  This is in recognition of the unique kind of emergency medical situations in which patients or family members cannot give informed consent before treatment as well as the need to allow emergency care to advance through research.

According to FDA regulations, to qualify for EFIC, the research study must involve participants suffering from a life-threatening disease process or injury for which the current standard of care is associated with a very high failure or mortality rate.  In addition, there must be reasonable evidence that the research has the potential to provide real and direct benefit to the patient.  Studies must be held to the highest ethical standards.  The ROC studies have undergone many independent rigorous reviews to ensure that they meet these standards.

The use of a randomized clinical trial such as this is the “gold standard” for determining what works best for people.  For treatments that must be given immediately to be effective, EFIC research is considered appropriate by federal regulatory bodies and many ethicists who study this field.  The obligation to improve standard treatments that yield poor results in life-threatening conditions is also considered an ethical imperative, as is maintaining individual rights of citizens.  In EFIC trials, citizens receive standard treatment in addition to research treatment.  To be tested in this fashion, the research treatment has to have shown promise in earlier or smaller studies.

If a family member is present when the patient has a cardiac arrest, why is the family not asked for permission? 
There isn’t time.  In order to give permission to participate in a study, it is important that the person giving permission understands what is being said to them, and can make a well-informed decision.  Family members are usually very upset during a medical emergency and are not able to concentrate or comprehend what is being said during the emergency.  Cardiac arrest is an extreme emergency during which the patient could potentially die if treatment is not begun immediately.  Patients suffering a cardiac arrest may be unconscious or too sick to discuss their treatment, and any time taken to discuss their treatment with family deprives the patient of immediately starting life-saving measures.

Once the injured patient reaches the emergency department, will the patient and/or family member be told about the study?
The study treatment will continue when the patient arrives in the emergency department. If it is feasible, an attempt will be made to obtain informed consent from the patient’s legally authorized representative or directly from the patient, if possible. The study continues until 72 hours following the cardiac arrest.  If informed consent is not obtained before the end of the 72-hour period, no further efforts will be made.  However, notification of the patient’s enrollment in the study will be attempted. The patient, the patient’s legally authorized representative or family member will be given the opportunity to withdraw the patient from further study participation and will be provided instruction for how to do so.

Are there any risks to the patient?
As is possible with any treatment, there are risks involved.  Patient safety is carefully monitored and recorded for any complications of study treatments.  The patients in this study will be treated with either an endotracheal tube (ET), or a laryngeal tube (LT). Both of these airway management devices are approved by the FDA (the US Food and Drug Administration), but are not specifically approved for use outside hospitals. EMS agencies are already using these devices, so most patients enrolled in this study will not be exposed to risks that they would not normally be exposed to during treatment for a cardiac arrest.

Can a person opt out of this research? 
Yes. We will provide an “Opt Out of ROC Research” wristband for those people who do not want to be enrolled in the study.  You can contact us by calling the Alabama Resuscitation Center at 205-934-9532 or email  

More information is available at; enter study ID NCT02419573.