Pilot Trial of Tubes to Prevent VAP (PreVent)
Pneumonia (infection of the lungs) is the most common infection that very sick patients in intensive care units get, and is more common when patients are on breathing machines (ventilators). Pneumonia can lead to more time on a breathing machine and in the intensive care unit, and may lead to death. Doctors at Harborview Medical Center are trying to find out if special breathing tubes that reduce leaking of fluids from the mouth and throat into the lungs may reduce the risk of getting pneumonia. The goal is to improve patient health after severe illness.
Two different kinds of breathing tubes that are placed in very sick patients are being studied. These tubes may help prevent pneumonia that sick or injured patients sometimes get when they are on breathing machines. Usually, patients in a study must provide written consent for participation after being told about the study, its risks and its possible benefits. In the case of emergency placement of breathing tubes, it is usually not possible for patients to give written consent, because they may be too sick or unconscious, and their families may not always be available to speak for them.
The U.S. Food and Drug Administration (FDA) allows for certain studies to be done without written consent in emergency settings, but only if patients have a high risk of dying without treatment, cannot talk because of their illness and don’t have family available to speak for them. When there is no other known treatment to improve their chance of living, patients may be given an experimental treatment but only if it has been approved beforehand by an independent review group.
The breathing tubes that will be used in this study are cleared for use by the FDA and are available for use in the United States and other countries, and have a good safety record. With the placement of any breathing tube there is a small risk of damage to the throat, and it is possible that the special tubes cause more damage than regular tubes. However, other studies that have used these tubes have not found this to be the case.
The PreVent study will include patients who need emergency placement of a breathing tube. The tube might be placed by paramedics outside the hospital in the city of Seattle, or by doctors if the patient if the patient is already at Harborview Medical Center. The decision to place the breathing tube will be made by the paramedics and doctors, and is not affected by the study. However, since placement of the breathing tube will occur in an emergency, patients will not be asked about their willingness to be part of in a research study. Patients or their families will be asked by one of the study team if they wish to continue in the study after they are admitted to the intensive care unit at Harborview Medical Center.
The study will enroll patients for approximately 4 months.
The PreVent study will include a total of 120 patients. Each subject will be randomly assigned (like flipping a coin) to one of three types of breathing tubes. Forty patients will receive a regular breathing tube, 40 will receive a tube with a special balloon, and 40 will receive a tube with a special balloon plus a hole to allow fluids to be sucked from the throat and mouth. The study will very carefully measure the benefits, risks, and costs associated with using these special tubes.
Participants will remain in the study for the duration of the placement of the tracheal tube. When the tracheal tube is removed, the study team will evaluate the airways for possible complications. The study team will also contact the participants four weeks after the removal of the tracheal tube to follow up and ascertain if there are persistent complications.
Click on the following links to download these study documents:
PreVent Study Contact: firstname.lastname@example.org