Emergency responders in portions of Clackamas, Washington and Yamhill counties are participating in a new nationwide clinical trial through Oregon Health & Science University, testing two strategies to help patients who require breathing assistance at the scene of a trauma.
The trial will help determine if one of two FDA-approved breathing devices works better at increasing survival outside the hospital.
The project includes OHSU, along with almost two dozen emergency medical service agencies across the country, in a Department of Defense-funded clinical trial that started in May of 2021 in the Portland metro region. Known as the Prehospital Airway Control Trial, or PACT, the $8.8 million study plans to enroll more than 2,000 people over four years.
The study is an “exception from informed consent” trial, meaning because the trial requires performing a potentially life-saving procedure in people who are too injured to give permission, patients who need help with breathing will be enrolled without consent. Patients will be asked for their permission for further participation once they or their legal representatives are able to consent.
Currently, there are two common strategies that emergency responders use to secure a person’s airway, each with advantages and disadvantages.
One in five preventable deaths from trauma occur because the patient is having difficulty breathing. In the U.S., most EMS personnel will secure an injured person’s airway with either an endotracheal tube or a supraglottic airway device, both of which help get oxygen to the lungs. Both consist of tubes that go through the mouth into or above the airway, and are then connected to a ventilation device — either a machine or a bag that can be pumped by hand — to deliver oxygen.
Endotracheal intubation requires the clinician to move the patient’s tongue aside, see the vocal chords and thread a tube between them into the patient’s windpipe. The supraglottic device also consists of a flexible tube inserted through the mouth, but instead of having to be threaded through the vocal cords, it sits at the back of the throat, above the windpipe.
The supraglottic is believed to be easier to place in the field because it doesn’t require seeing the vocal cords, meaning the airway can be secured faster and with less interruption of other resuscitation measures . But, when placed correctly, the endotracheal tube may be associated with less risk of the patient breathing fluid into the lungs.
“If we can show that one strategy is better than the other, it would change the way we manage trauma patients nationally,” said Mohamud Daya, M.D., M.S., principal investigator at OHSU and a professor of emergency medicine in the OHSU School of Medicine.
Both devices are approved by the FDA and are used regionally.
Daya said he expects the new study will enroll 25 to 50 people per year in the Portland metro area. Patients enrolled in the study will be transported to OHSU Hospital.
Participating EMS services will start by using their normal procedures to secure an airway, and the trial will collect data on patient outcomes. Then, the services will switch to trying the supraglottic airway first. If it fails, they can then decide whether to try the supraglottic again or switch to endotracheal intubation.
The University of Pittsburgh School of Medicine is the clinical coordinating center for the study, which along with OHSU is part of the Department of Defense’s Linking Investigations in Trauma and Emergency Services (LITES) research network of U.S. trauma systems and centers.
Other centers participating in the trial include East Carolina University, Emory University, Cook County Trauma Services in Chicago, University of Louisville, Tulane University, Vanderbilt University, and Washington University in Missouri.
The research is funded by DOD contract W81XWH18F0426.
For more about the study, visit https://www.litesnetwork.org/pact-efic/