The study will observe two sedation medications, ketamine and etomidate, that are most commonly used for sedations, ketamine and etomidate, to determine which is best during intubations.Researchers at the University of Alabama at Birmingham are conducting a study to determine which medication is best to sedate patients that are being placed on a breathing machine with regards to blood pressure, oxygen levels and heart function.
The study, called the “Randomized Trial of Sedative Choice for Intubation” will observe two medications that are most commonly used for sedation with intubations, ketamine and etomidate. While both are considered safe and effective, medical professionals are unaware which drug is best to use during intubations.
“Through this study, we are trying to determine the best drug to use for patients that are critically ill and already need a breathing tube inserted to support their breathing,” said Sheetal Gandotra, M.D., associate professor in the UAB Division of Pulmonary, Allergy and Critical Care Medicine. “We hope that the results of this study will help us improve patient care and outcomes of patients in our hospitals.”
During the trial, patients who are placed on a breathing machine in the emergency department or intensive care unit at UAB Hospital will receive the medication that the doctor recommends, and if there is no preference, the patient would be assigned ketamine or etomidate randomly. This process will ensure that every patient has a fair and equal chance of receiving either drug.
Due to the severity of a patient’s health when intubation is needed, patients may not be able to give their oral or written consent to participate in the study. This type of trial falls within a special set of government rules known as “exception from informed consent.”
“Doctors make sure that any patient who participates in a study is aware that the treatment is being studied for how well it works and explain any risks that may be present,” said Derek Russell, M.D., associate professor in the Division of Pulmonary, Allergy and Critical Care Medicine. “Patients are asked whether they understand and whether they agree to participate – that’s informed consent. However, in situations where people are urgently sick, they don’t have the ability to agree to participate in a trial and in these cases, the study operates under an exception from the informed consent process.”
EFIC trials are used in instances of a life-threatening illness or injury when the patient population being studied is unconscious or too sick to provide written or verbal informed consent to be enrolled in a trial. The federal rules for EFIC trials were developed in 1996. EFIC studies are held to the highest ethical standards and undergo scrutiny by multiple agencies. Researchers must show there is reasonable evidence the study has the potential to provide real and direct benefit to the patient. The study must hold the premise that the new treatment is better than what is currently available.
If one decides they would not like to not participate in the study preemptively, email LungHealth@uabmc.edu. A bracelet will be sent that can be worn to inform medical teams of the decision, even if that patient is unconscious.
To learn more about the study, visit the study website at www.pragmaticcriticalcare.org/RSI.