In the emergency department or intensive care unit of a hospital, seriously ill patients are often supported with a breathing machine. Many seriously ill patients on a breathing machine die in the hospital. For those who survive, the pain, confusion and fear of being on a breathing machine can lead to symptoms of post-traumatic stress disorder (PTSD). This includes nightmares, negative thoughts and trouble sleeping and concentrating. These symptoms can last for months or years and impair survivors’ ability to work, perform everyday tasks and have healthy relationships.
Consider Kelly’s story:
Kelly had a serious lung disease, for which she needed a transplant. She was put to sleep, was placed on a breathing machine, completed the transplant procedure, woke up, recovered and returned home feeling great. A year later, her husband became seriously ill with COVID-19. He was put to sleep, was placed on a breathing machine and spent three weeks in the hospital. Ever since, he has suffered nightmares and frightening memories. He struggles to sleep. He has not been able to work. Kelly wonders: Why did this happen to him and not me? Could this have been prevented?
To provide support with a breathing machine, doctors must place a breathing tube into the patient’s mouth and throat. Doctors give patients a medication to make them sleep during this procedure. The two medications doctors most often give are called ketamine and etomidate. Some doctors usually give ketamine. Some doctors usually give etomidate. Even though these two medications have been around for decades, it is still unknown which one is best for patients. Knowing which of the two medications helps patients survive or prevents symptoms of PTSD could save lives and improve mental health for tens of thousands of seriously ill patients every year.
To help doctors be able choose the best medication (ketamine or etomidate) for seriously ill patients receiving a breathing tube, the project team is conducting a large study at five hospital systems across the country. This study seeks to answer three questions:
- Which medication helps more patients survive their serious illness?
- Which medication helps patients have fewer symptoms of PTSD?
- Which medication is best for which types of patients?
Seriously ill patients receiving a breathing tube in the emergency department or intensive care unit will be able to take part in the study if their doctors think that using either ketamine or etomidate is safe. Each patient in the study will have an equal chance of receiving ketamine or etomidate. Researchers will meet with patients in the hospital and then call patients at three and 12 months.
The study’s main outcome is the number of patients who are alive at one month. The project team will determine this outcome by reviewing electronic health records and speaking to families. The secondary outcome will be patients’ symptoms of PTSD at 12 months. Members of the research group will ask patients about their PTSD symptoms over the phone. They will also ask questions about how patients are thinking and feeling.
The study will be led by a team of five patients who have experienced serious illness; five doctors who care for patients with serious illness; and researchers from five hospitals with experience in serious illness, mental health and involving patients and community members in research. An independent group of patients and community members from the five cities will help oversee and direct the study. Every four months, additional patients and clinicians with diverse backgrounds will share their experiences, answer questions and advise the study’s design and conduct. Patient and clinician advocacy organizations will help design and shape the study.
When the study is done, the findings will be shared with patients, families and doctors everywhere. The findings will be made available in articles in scientific journals; in presentations at medical conferences; through simple summaries, pictures, and videos; on websites and social media; in newspapers and at town halls and community meetings.
Determining which of these two common medications is best, and then sharing that knowledge broadly, will help many seriously ill patients live longer, more satisfying lives.
*All proposed projects, including requested budgets and project periods, are approved subject to a programmatic and budget review by PCORI staff and the negotiation of a formal award contract.