This research trial studies patients in cardiac arrest. Cardiac arrest is a medical emergency where the heart stops beating, the patient collapses suddenly, and the patient stops breathing normally. Typically, paramedics are called to the scene via 911 and attempt to resuscitate the patient.
Resuscitation includes CPR (chest compressions, artificial breathing with oxygen, and electric shocks). About 1 person in 10 survives cardiac arrest that happens outside of the hospital.'
In cardiac arrest, paramedics usually place tubes in the mouth and throat to help deliver oxygen. These tubes are superior for delivering oxygen compared to a mask over the face. Two different types of tubes are widely used: endotracheal intubation (ETI) or laryngeal tube (LT) placement.
ETI is the most common technique used in the hospital, and in emergency situations outside of hospitals. For ETI, paramedics place a large, lighted metal laryngoscope (like a big tongue depressor) into the mouth in order to see the vocal cords. Once the vocal cords are seen, the provider inserts a plastic breathing tube through the vocal cords, and into the trachea, or windpipe. In the US, paramedics have performed ETI for over 30 years. This technique requires practice and skill, and some studies found a higher-than-desired failure rate of inserting this type of tube properly outside of the hospital.
LT placement involves inserting a tube straight into the esophagus (the opening to the stomach, where you swallow food) instead of the trachea. This tube blocks off the opening to the esophagus so that air can only go into the trachea and lungs. This technique does not require as much training as is required for the endotracheal tube, because paramedics do not need to be able to see the vocal cords. This tube is usually replaced by ETI after a patient arrives at the hospital.
While both of these airway tubes are approved by the US Food and Drug Administration (FDA) and LT use by paramedics is increasing, there have been no studies testing whether LT is better or worse than ETI when used by paramedics outside of the hospital.
This study will compare ETI versus LT placement during cardiac arrest. Several EMS agencies in the Pittsburgh area will participate in this study. The EMS agencies already perform ETI or LT placement, but they will receive additional training before beginning the study. Each ambulance will use one of the tubes (ETI or LT) as their first-line approach for a period of time (weeks or months), and then will switch to using the other tube. Any time that a paramedic is not able to insert one tube successfully, he or she is allowed to use the alternate tube as a backup. This research will look at the outcomes of people who are enrolled in the study, to see if patients treated with ETI first or the LT first have a higher survival rate or any complications. This study will only enroll adults, ages 18 and over.
Patients having a cardiac arrest are always unconscious, and cannot give consent to be in research study. In addition, these treatments must be given within seconds. Therefore, we are asking permission to conduct this research with an exception from informed consent. After a patient regains consciousness, he or she will be able to withdraw from further involvement in the study. In addition, researchers will notify the family or legally authorized representatives of any patient about the study as soon as feasible after the emergency.
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