February 12, 2024
The Emergency Department at Denver Health is participating in a national study to evaluate if one of two commonly used sedative medications during intubation improves outcomes for severely ill adult patients.
Intubation is a high-risk medical procedure that is done to put a severely ill patient on a breathing machine. One in four of these patients experience serious problems with blood pressure or oxygen levels during this procedure.
Some of the risk of this procedure is related to the sedative medications given to patients to make them sleepy. The two most common sedatives used for intubation are etomidate and ketamine. Both have been used for decades and are approved by the U.S. Food and Drug Administration (FDA).
However, it is not known if one drug is better for patients overall, or among patients with specific medical problems. Denver Health’s participation in this study seeks to help answer these important questions
“Knowing if one of these two drugs improves patient outcomes will help emergency and critical care clinicians take better care of the sickest patients during this life-saving procedure,” Stacy Trent, MD, Denver Health Emergency Department physician and researcher, said.
Beginning in the spring of 2024, the Emergency Department at Denver Health will begin participation in the “Randomized Trial of Sedative Choice for Intubation” (RSI) study. The goal is to evaluate whether one of these drugs improves outcomes for patients, such as preventing low blood pressure, low oxygen levels, serious heart problems and death, as compared to the other drug.
During this study, if a seriously ill adult patient needs to be put on a breathing machine in the Denver Health Emergency Department, the emergency physician will decide if the patient is eligible for this study. Patients will only be included if the physician determines that both sedative drugs, etomidate and ketamine, are equally effective for that patient. In this case, the choice between the two drugs will be made randomly by the study.
Most patients requiring intubation in the emergency department are unconscious or in serious distress. Consequently, intubation is an emergency procedure. There is no time for doctors to discuss the risks and benefits of the procedure with the patient. Doctors must typically go ahead with life-saving care without the patient’s consent. For these same reasons, doctors may not be able to get a patient’s consent to take part in this study.
Important research to find the best care for life-threatening conditions, like the RSI study, is conducted through a process called “Exception from Informed Consent” (EFIC), in which the study is overseen by the FDA and an independent ethics committee. Researchers will meet with each patient or family member after the procedure has been completed to discuss the study.
Denver Health researcher, Dr. Stacy Trent, MD, will be collaborating with researchers from Vanderbilt University, Hennepin Medical Center, Wake Forest, the University of Colorado and the University of Alabama. This study is funded by the Patient Centered Outcomes Research Institute (PCORI).
To learn more about the “Randomized Trial of Sedative Choice for Intubation,” visit the study website at https://www.pragmaticcriticalcare.org/rsi.
