When taken to a hospital emergency room, few patients have the means to choose the type of breathing tube that will be inserted into their throat.
This is why OHSU is about to conduct a special type of clinical trial that recruits patients without their written consent. The United States Food and Drug Administration allows certain studies to be performed without written consent in emergency situations, provided that the patient has a high risk of dying without treatment, cannot speak because of their illness, no have no family available to speak on their behalf, and community members can opt out. (See the sidebar for unsubscribe instructions.)
The trial will compare two types of breathing tubes:
A standard tube currently in use in most emergency rooms and hospitals nationwide.
A specialized tube designed to reduce the risk of fluids leaking from the mouth and throat into the lungs, thereby reducing the risk of pneumonia.
The trial begins in April and is expected to last 36 months. It will enroll a total of 1,074 patients, half receiving the standard tube and the other half receiving the specialized tube. Known as a randomized controlled trial, the study will measure the benefits and risks resulting from specialized tubes compared to the standard tube.
The specialized tube has already been approved by the FDA as safe for clinical use. The new study will determine whether it is so effective that it should be adopted as the standard of care across the medical profession.
“It could change clinical practice across the country and the world,” said Miriam Treggiari, MD, Ph.D., MPH, professor of anesthesiology and perioperative medicine at the OHSU School of Medicine who is leading the study.
The specialized tube includes a special balloon and an additional port that sucks fluids from the throat and mouth.
It is designed to reduce the risk of pneumonia, the most common infection in sick patients in intensive care units. Pneumonia can cause an increase in the time spent on a respirator and can increase the risk of death.
Participants will be followed for six months after placement of the breathing tube. While the tube is in place, researchers will watch for pneumonia and other possible complications. Six months after the breathing tube is removed, the study team will contact participants to determine if there are any lingering complications and their well-being.
The title of the study is “Randomized Trial of Endotracheal Tubes to Prevent Ventilator-Associated Pneumonia – Prevention Study 2” and is funded by the National Heart, Blood and Lung Institute of the National Institutes of Health with grants R61HL138650-01A1 and R33HL138650. Monitoring is provided by the FDA; the National Institute of the Heart, Blood and Lungs of the National Institutes of Health; and the OHSU Institutional Review Board and an independent Data Security Oversight Board.
If you wish to withdraw from the study, contact: 833-376-1027 or [email protected]
Details of the PreVent 2 study: apomocean.ohsu.edu