The procedure to place a severely ill patient on a breathing machine (intubation), can be high-risk. One in four severely ill patients undergoing intubation in the Emergency Department or Intensive Care Unit experiences serious problems with blood pressure or oxygen levels during this procedure.
Some of these risks may be related to the medication used during the procedure to make the patient sleepy (a sedative). The two medications doctors give most often in this situation are ketamine and etomidate. Both are approved by the U.S. Food and Drug Administration (FDA), and have been in use for decades, but it is not known whether one drug is better for patients, overall, or among patients with specific medical problems.
Starting on April 4, Vanderbilt providers initiated the “Randomized Trial of Sedative Choice for Intubation” (RSI) study to determine whether ketamine or etomidate is better for preventing low blood pressure, low oxygen levels, serious heart problems, or even death for severely ill patients undergoing intubation.
Approximately 1,900 patients will be enrolled. During the study, when providers are caring for a severely ill patient in the Vanderbilt Emergency Department or Intensive Care Unit who needs to be placed on a breathing machine, and they believe that ketamine and etomidate would be equally effective for that patient, the choice between the two will be made by the RSI study.
“Knowing whether the two drugs are the same for patients, or if one is better, could improve care for tens of thousands of patients every year,” says Jonathan Casey, MD, assistant professor of Allergy, Pulmonary and Critical Care Medicine, who is leading the study.
“Determining which of these two commonly-used medications is best will help doctors take better care of the sickest patients during this life-saving emergency procedure,” said Matthew Semler, MD, assistant professor of Allergy, Pulmonary and Critical Care Medicine.
Placing seriously ill patients on a breathing machine is an emergency procedure. Most patients requiring intubation in the Emergency Department or Intensive Care Unit are unconscious or in distress. There is often no time for doctors to discuss the risks and benefits of the procedure with the patient. Physicians typically must go ahead with lifesaving 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 the RSI study. Important research to find the best care for life-threatening conditions, like the RSI study, is therefore conducted through a process called “Exception from Informed Consent” (EFIC), in which the study is overseen by the FDA and an independent ethics committee, and researchers meet with each patient or family member after the procedure has been completed to discuss the study.
VUMC researchers in addition to Casey and Semler include Kevin Seitz, MD, and Todd Rice, MD, in the Division of Allergy, Pulmonary and Critical Care Medicine; and Wesley Self, MD, Jin Ho Han, MD, Aaron Lacy, MD, and Graham Van Schaik, MD, in the Department of Emergency Medicine. The study is funded by The National Heart, Lung, and Blood Institute grant K23-HL153584.