UA Department of Emergency Medicine Seeks Community Input On Study of a New Airway Device

An Institutional Review Board responsible for human subjects research at the University of Arizona reviewed this research project and found it to be acceptable, according to applicable state and federal regulations and UA policies designed to protect the rights and welfare of participants in research.

The purpose of the study is to determine if an investigational device, the SolidAIRity®Airway Stabilization System, is able to deliver better health care to patients in need of an endotracheal (breathing) tube, a life-sustaining measure provided to critically ill or injured patients who need a tube placed through the mouth into the windpipe (trachea) to assist with breathing.

A breathing tube is used to help individuals who cannot keep their airway open on their own or who cannot breathe adequately due to unconsciousness, trauma, disease, drugs or anesthesia. In approximately 7 out of 100 patients, the endotracheal tube comes out accidentally. These unintended removals of life sustaining breathing tubes are called unplanned extubations and often are unpredictable and can be caused by a variety of reasons, ranging from a cough that dislodges the tube to disoriented patients who pull the tube out on their own. Unplanned extubations increase the risk for serious complications, including pneumonia, brain injury and death. 

The SolidAIRity®Airway Stabilization System has been designed to help better prevent the occurrence of unplanned extubations. During the clinical trial, the system will be used on patients to evaluate how safe and effective it is compared to the current systems used to secure an endotracheal tube.

Because critically injured patients often are unconscious and unable to give consent to participate in the study, this trial falls under a unique U.S. Food and Drug Administration (FDA) regulation concerning “exception from informed consent (EFIC).”  Such regulations are strict and the research must meet very specific federal regulations and local Institutional Review Board (IRB) review and approval. They give physicians in the emergency center the ability to enroll patients into the study – even though they cannot speak for themselves to give or deny consent because of life-threatening injury or illness.

One requirement of this regulation is that the community receives education about the study. The Arizona Emergency Medicine Research Center in the UA Department of Emergency Medicine is in the process of providing information to the community and asking for feedback. You can provide feedback to the researchers or request an opt-out bracelet that indicates to medical staff that you do not want to be to be part of the study.

If you would like to participate in a survey, provide feedback, ask questions or request an opt-out bracelet, please contact the primary nurse coordinator for the trial, Matt Nelson, 520-626-8534. 

For more information about the Arizona Emergency Medicine Research Center, visit their website at