What we need to learn

To safely connect a patient to a breathing machine, doctors place a breathing tube through the mouth and between the vocal cords (intubation). A breathing tube can put pressure on a patient’s voice box and cause an ulcer (similar to how shoes can cause blisters on feet). If an ulcer develops, it can cause long-term problems with breathing, speaking, and swallowing even after the tube is taken out. Some breathing tubes are smaller and some are larger.  Using smaller breathing tubes may prevent these long-term problems with breathing, speaking, and swallowing, whereas using larger breathing tubes may help patients get off of the breathing machine faster.

What we are doing

Doctors and nurses are doing a research study to try and learn which carbon dioxide test is best for our pThis research study is called the “Tube Size Randomized Trial during Emergency Tracheal Intubation” (BREATHE) and is funded by the Patient Centered Outcomes Research Institute (PCORI). The goal of the study is to learn whether smaller or larger breathing tubes (personalized for a patient’s height) are better for getting patients through their critical illness and preventing long-term problems with breathing, speaking, and swallowing.

Participating in this study will not impact the quality of care patients receive. For each patient:

• When the doctors feel a smaller tube would be best for a patient, they will use a smaller breathing tube, and the patient does not take part in the study.
• When the doctors feel that a larger breathing tube would be best for a patient, they will use a larger breathing tube, and the patient does not take part in the study.
• When the doctors think that both a smaller and larger breathing tube would be equally safe and effective for the patient, the patient will be enrolled in the BREATHE study and the breathing tube will be randomly chosen by the BREATHE study. If, at any time, the patient’s condition changes, doctors can change the breathing tube for whatever size they think is needed.

The study team will:

• confidentially review the patient’s medical record
• meet with the patient after the breathing tube is removed
• explain the study and ask for permission to contact the patient 6 months after breathing tube placement
• ask the patient at 6 months after breathing tube placement about his or her breathing, speaking, and swallowing

Questions

If you have any questions or concerns about this study, you may contact the Principal
Investigator, Dr. Jonathan Casey at Jonathan.d.casey@vumc.org or (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 Medical Center
• Denver Health
• Hennepin Healthcare
• University of Alabama at Birmingham
• University of Colorado at Denver
• University of Washington
• Wake Forest Atrium Health

Frequently Asked Questions

What is a breathing machine? 

Some seriously ill patients in the hospital need help to breathe. In this situation a breathing machine – also known as a “mechanical ventilator” – is used to breathe for the patient while they heal. A breathing machine helps move air in and out of the lungs to maintain proper levels of oxygen in the blood. To use a breathing machine, the doctors and nurses insert a tube through the mouth to reach the lungs. The procedure for inserting a tube into the mouth to reach the lungs is called “intubation”. 

What are the risks of each size tube? 

Both smaller and larger breath tubes are used every day across the world. As far as we know today, both smaller and larger breathing tubes are equally safe and effective. However, it is possible that smaller breathing tubes could reduce the risk of injury to the voice box while larger breathing tubes help get patients through their illness and off the breathing machine faster. The goal of the BREATHE study is to determine if breathing tube size affects any of these risks.

Who is eligible for the BREATHE study? 

• Adults who are receiving treatment in a participating emergency room or intensive care
• unit (ICU) whose doctors have determined that they need a breathing tube may be
• eligible for this study. Patients are eligible only if their doctors and nurses think that
• using either a smaller or larger breathing tube would be consistent with optimal care for
• them. Patients can only participate if they are undergoing breathing tube placement at a
• hospital participating in the study. They cannot volunteer at any other time. 

This work is supported through a Patient-Centered Outcomes Research Institute (PCORI) Project Program Award (BPS 2024C1-37478).

We want to know what you think about the BREATHE study

We welcome feedback and questions from the community about research like this. If you have comments or questions please contact Dr. Jonathan Casey at Jonathan.d.casey@vumc.org or (615) 208-6139