What we need to learn

When a patient needs a breathing machine, a breathing tube is placed through the mouth and into the windpipe. Difficulty placing the breathing tube may cause serious problems with low oxygen levels, low blood pressure, or injury to the windpipe or lungs. To place the breathing tube, doctors use a curved tool (called a “scope”) to see inside the mouth. Two types of “scope” are commonly used. One has a video screen. The other does not. Both types of “scope” are FDA approved and frequently used in the emergency department (ED) and intensive care unit (ICU). The purpose of this study is to determine if one type of ”scope” is better than the other.

What we are doing

This study is called “Direct Versus Video Laryngoscope (DEVICE)” and is funded by the U.S. Department of Defense. Our goal is to learn whether a “scope” with a video screen or a “scope” without a video screen is better for placing a breathing tube and preventing problems with oxygen levels and blood pressure. Participating in this study will not impact the quality of care patients receive. For each patient:

• When the doctors feel a “scope” with a video screen would be best for a patient, the team will use a “scope” with a video screen.
• When the doctors feel that a “scope” without a video screen would be best for a patient, the team will use a “scope” without a video screen.
• When the doctors do not have a preference, the patient will be assessed against the inclusion / exclusion criteria and when appropriate, enrolled in DEVICE. Once the patient is enrolled in DEVICE, the type of “scope” is assigned randomly, meaning that every patient will have a fair and equal chance of getting either type of “scope.”

Questions

If you have any questions or concerns about this study, you may contact the Principal Investigator, Dr. Jonathan Casey. He will be glad to answer any study-related questions. Dr. Casey’s phone number is (615) 208-6139. If you have questions about your rights as a research participant, or concerns or complaints about the research, you may also contact the Vanderbilt Human Research Protections Program at (615)- 322-2918.

Participating Sites

Vanderbilt; Denver Health; Ochsner; University of Washington; Duke University; University of Alabama, Birmingham; Baylor, Scott &White; University of Colorado, Denver; Hennepin County Medical Center; Wake Forest; Brooke Army Medical Center, Beth Israel Deaconess,

Trial Update

On November 17^th 2022, the investigators were notified by the Data and Safety Monitoring Board that the DEVICE trial had met the prespecified stopping criteria at the time of the single interim analysis.  Enrollment in the trial was stopped and investigators and clinicians at participating sites were notified.

Doctors and scientists started the “Randomized Trial of Sedative Choice for Intubation (RSI)” in April of 2022. 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.

Participating Sites

Vanderbilt

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.

What we need to learn

When patients need a breathing machine, a breathing tube is placed through the mouth and into the windpipe. During placement of the breathing tube, patients may experience serious problems with low oxygen levels or low blood pressure. Doctors give oxygen through a mask before the procedure to prevent low oxygen levels. Two types of oxygen mask are commonly used. Both provide oxygen. One also provides pressure to open the lungs. Both types of masks are FDA approved and both are frequently used in emergency department (ED) and intensive care unit (ICU). The purpose of this study is to determine if one type of mask is better than the other.

What we are doing

This study is called “Pragmatic Trial Examining Oxygenation prior to Intubation (PREOXI),” and is funded by the U.S. Department of Defense. Our goal is to learn whether an oxygen mask with pressure or an oxygen mask without pressure is better for preventing problems with low oxygen levels. Participating in this study will not impact the quality of care patients receive. For each patient:

When the doctors feel an oxygen mask with pressure would be best for a patient, the team will use an oxygen mask with pressure.

When the doctors feel that oxygen mask without pressure would be best for a patient, the team will use an oxygen mask without pressure.

When the doctors do not have a preference, the patient will be assessed against the inclusion/exclusion criteria and when appropriate, enrolled in PREOXI. Once the patient is enrolled in PREOXI, the type of mask is assigned randomly. This means every patient will have a fair and equal chance of getting either type of mask.

Questions

If you have any questions or concerns about this study, you may contact the Principal Investigator, Dr. Jonathan Casey. He will be glad to answer any study-related questions. Dr. Casey’s phone number is (615) 208-6139. If you have questions about your rights as a research participant, or concerns or complaints about the research, you may also contact the Vanderbilt Human Research Protections Program at (615)- 322-2918.

Participating Sites

Vanderbilt; University of Alabama, Birmingham; Baylor, Scott &White; University of Colorado, Denver; Hennepin County Medical Center; Wake Forest; Brooke Army Medical Center; Lahey Health; Oregon Health & Sciences University; University of Iowa; Ohio State; University of Wisconsin; Montefiore Medical Center; Our Lady of the Lake Medical Center