Doctors and scientists are preparing to start the “Randomized Trial of Sedative Choice for Intubation (RSI)” in November of 2021. This website provides information about the RSI study.
The goal of the RSI trial is to learn which of two drugs (“ketamine” or “etomidate”) is best for patients receiving a breathing tube – overall and for specific groups of patients with medical problems like heart disease or severe infection.
Why the RSI Study is Needed:
|Each year millions of seriously ill adults need life-saving treatment with a breathing machine. To safely place someone on a breathing machine (a procedure known as “intubation”), doctors give a drug to make the |
patient sleepy (known as a “sedative”). The two “sedative” drugs given most often to seriously ill patients receiving a breathing tube in the United States are ketamine and etomidate. Both drugs are approved by the United States Food and Drug Administration (FDA).
Both are considered safe and effective. Both are given by doctors all the time. But it is not known which drug is best.
Each drug may have benefits or risks. Ketamine may have a temporary negative effect on heart function in some patients. Etomidate may have a temporary negative effect on the hormones that help keep blood pressure normal. Early studies suggested that patients did equally well with the two drugs. Knowing for certain whether the two drugs really are the same for patients, or if one is better, could save many patients lives in the future.
What we are doing
Doctors and scientists are doing the “Randomized Trial of Sedative Choice for Intubation (RSI)” study to learn for certain whether ketamine and etomidate are the same for patients being placed on a breathing machine, or if one is better for preventing serious problems with blood pressure, oxygen levels, or heart function.
For patients being placed on a breathing machine in an emergency department or an intensive care unit that is part of the RSI study:
- When the doctors feel ketamine would be best for a patient, the doctors give the patient ketamine.
- When the doctors feel that etomidate would be best for a patient, the doctors give the patient etomidate.
- When the doctors do not have a preference, the patient participates in the RSI study and assigned either ketamine or etomidate randomly. This means every patient has a fair and equal chance of getting either drug.
Remember: Both drugs are commonly used to place patients on breathing machines. Both are approved by the FDA for this use. Both are deemed safe and effective. Only when doctors do not have a preference does the RSI study choose the drug – and even then the doctors can always choose to use another drug to ensure the best care for the patient. During the placement of a breathing tube doctors and nurses are standing with the patient, closely watching to keep them safe, and preventing and treating possible problems.
Consent for Emergency Care
Placing seriously ill adults on a breathing machine is an emergency procedure. There is often no time for doctors to discuss the risks and benefits of the procedure or of the drug that will be used. Patients are often unconscious or too sick to make decisions. So, doctors go ahead with life-saving care without the patient’s okay (consent).
Consent for Research during Emergency Care
For these same reasons, it may not be possible for patients to give consent to take part in the RSI study. Important research to find the best emergency care, like the RSI study, can sometimes be done without getting patients’ okay (consent) ahead of time through a process called “Exception from Informed Consent” (EFIC). Studies done with EFIC are designed with input from patients, families, and community member and overseen by the FDA (FDA 21 CFR 50.24 ) and an independent ethics committee.
If you are seriously ill and are being placed on a breathing machine in an emergency department or intensive care unit taking part in the RSI study, your doctors feel that using either ketamine or etomidate would be safe and effective for you, AND there is not enough time to ask you or your family if you would like to take part in the RSI study:
- You would be enrolled in the study.
- You would receive whichever of the two drugs is randomly chosen by the study.
- A study team member would come to you (or your family) after the procedure and give you information about the study, answer your questions, and let you know how you could choose to stop taking part in the study.
We want to know what you think about the RSI Trial
We want feedback from the community about research like this. Please share your opinions at: https://redcap.link/rsitrial
If you do not wish to participate in this study
If you would not want to participate in this research study can if you became severely ill and needed treatment with a breathing machine, you can contact us at Jonathan.D.Casey@vumc.org or 615-208-6139. We will send you a bracelet you can wear that will inform your medical team of your decision even if you are unconscious.