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