EvK Clinical Trial
Frequently Asked Questions:
1) Are etomidate and ketamine commonly used for sedation (or anesthesia) during emergency endotracheal intubation?
Yes. Both are commonly used, and both are the “standard-of-care” locally and nationally.
2) If both etomidate and ketamine are frequently used for this procedure, why are you doing the study?
There is considerable debate right now regarding which medication is better for patients. Each medication has side effects. We are trying to determine which is better for patients.
3) What does it mean to “randomize” a patient?
This means that individual patients who are enrolled in the study will receive either etomidate or ketamine. Which medication they will receive will depend on random chance, similar to what happens with a coin toss.
4) Besides receiving etomidate or ketamine, will patients in the study have any other study-related procedures?
No. The only intervention for the study is the choice of etomidate or ketamine, which will be done by random selection. Data will be gathered from the patient’s medical record after they enter the study, but this will not have any effect on medical care.
5) Why won’t patients have a chance to sign a consent form before enrolling in the study?
The EvK Trial is a study of an emergency medical procedure. The patients who are eligible for the study are critically ill and require immediate medical care (placement of a breathing tube), and therefore cannot give informed consent. After a patient is enrolled in the study, the study team will notify the patient and / or family of study enrollment, in accordance with FDA rules governing emergency medical research (FDA 21 CFR 50.24).
6) Is it legal to do a research study on a patient before he or she give written informed consent?
Yes, provided the study complies with the regulations governing this type of research. The U.S. Food and Drug Administration (FDA) has determined that in select cases of emergency research it is acceptable to do research without first obtaining written informed consent. Information about this can be found in the Documents section above, and at the FDA website.
7) Who is eligible to enroll in the study? Can patients volunteer for the study?
The EvK Trial will enroll patients who are critically ill, and specifically those who require emergency placement of a breathing tube. These patients are typically found in an emergency department, or intensive care unit, who are there under emergency circumstances. Because of this, individuals cannot volunteer for this study.
8) How was the public notified about the EvK Clinical Trial?
The U.S. Food and Drug Administration (FDA) requires that several specific measures be taken for research in emergency medical conditions. These measures are described in FDA 21 CFR 50.24. The EvK Trial investigators completed a comprehensive Community Consultation Plan that included this website, letters to more than 300 community leaders, social media, online advertising, newspaper advertising, and open Community Meetings. The open Community Meetings were held on April 4, 6 and 11, 2016. Information about our Community Consultation Plan can be found in the Documents tab above. Additional meetings and outreach will be scheduled if there is community interest.
9) How many patients will enroll in the EvK Clinical Trial?
Approximately 825 patients will enroll.
10) Will the study investigators make money off the results of this study?
No. The EvK Trial collaborators do not have a financial stake in the outcome of the study. The study is primarily funded by the Dept. of Anesthesiology at the University of Texas-Southwestern Medical Center. Both medications used in the EvK Trial (etomidate and ketamine) are generic medications, and the study is not being done to market either medication. The EvK Trial is not a “for profit” study. No drug companies, or their agents or representatives, were involved in the design of this study, and none will be involved in the conduct of the study.
11) How do I contact the research team if I have questions or concerns?
Gerald Matchett, M.D., Principal Investigator
Dept. of Anesthesiology & Pain Management
University of Texas-Southwestern Medical Center
5323 Harry Hines Blvd, Dallas, TX 75390-9068
12) I would like to formally “opt-out” of the study. How do I do that?
Individuals who live or work in the catchment area of Parkland Hospital in Dallas, TX may “opt-out” of the study. To do this, please request to opt-out using the contact information above. You will be sent a custom MedAlert bracelet indicating this choice. The bracelet will be sent to you free of charge by mail.
13) Is this study approved by an Institutional Review Board (IRB)?
Yes. The UT-Southwestern IRB has reviewed the study (IRB Study Number STU#022015-023). The study is also approved by the Parkland Clinical Research Office (CRO). Detailed information is available in the Documents tab, above. The study is also registered on clinicaltrias.gov (study registration number NCT02643381).
14) How long will this clinical trial take?
Approximately 2-3 years
15) Will the results of this research be announced?
Yes. Results will be announced publicly through various methods, including publication in a scientific journal. No Protected Health Information (PHI) will be published or publicly disclosed.
16) My group or organization would like to schedule a meeting with Dr. Matchett. Can we do that?
Yes. Dr. Matchett will welcome the opportunity to discuss this clinical trial with any group, individual or organization. Please contact Dr. Matchett using one of the methods in the Contact Us link. Translator services are available.