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PreVent 2 Study
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INFORMATION FOR

Study Information

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Study Background

Pneumonia (infection in the lungs) is a common and serious problem in patients who are critically ill and require the support of a breathing machine (mechanical ventilation) through a breathing tube. Pneumonia can make patients very sick by reducing the oxygen in the blood and the oxygen supply to the brain. It can also cause an inflammatory response that can affect brain function with a long-term decline in mental abilities. Pneumonia can lead to more time on a breathing machine and in the intensive care unit and may lead to death.

One of the causes of pneumonia in patients on mechanical ventilation is the leakage of fluids that are contaminated with germs from the mouth and throat, down into the lungs. These fluid secretions tend to leak around regular breathing tubes. However, there are specialized tubes that are designed to prevent leakage of secretions into the lungs. One of these tubes has an extra small channel that allows saliva and other secretions to be suctioned out of the back of the throat before they can leak down into the lungs. However, it is not clear if this tube (compared to a regular tube) is more effective or safe in preventing pneumonia. Both tubes are approved for use by the Food and Drug Administration, they have good safety profiles, and are commonly used in clinical practice.

Doctors at Yale New Haven Hospital are trying to find out if the specialized breathing tubes reduce the risk of getting pneumonia, in comparison with regular breathing tubes, and if preventing pneumonia improves the long-term quality of life and ability to think at six months after the placement of the breathing tube. We will also evaluate if the special breathing tube is as safe as the regular endotracheal tube. Our goal is to improve patient health after severe illness.

Eligibility

Inclusion Criteria

  1. Adults requiring endotracheal intubation in the emergency department or in the hospital AND
  2. A study intubation kit containing the study ID number must have been used for the emergency intubation.
  3. Admitted to the ICU and receiving mechanical ventilation

Exclusion Criteria

  1. Patients electively intubated in the operating room whether or not they require subsequent ICU admission
  2. Use of a non-study designated intubation kit (such as nasal intubation, tracheotomy, intubation occurring at a location not supplied with the study intubation kits)
  3. Patients with permanent tracheostomy
  4. Protected populations including children (age <18 years), pregnant women, or prisoners
  5. Evidence of unwillingness to participate in a research study through the patient’s electronic medical record, or at the time of intubation if there is opportunity to read the consent script

Study Design

The study will be a Phase II randomized, controlled trial that will be conducted under the Exception from Informed Consent regulations. The study will equally randomize 1,074 patients requiring emergency endotracheal intubation to receive either a polyurethane-cuffed endotracheal tube equipped with continuous aspiration of subglottic secretions designed to prevent ventilator-associated pneumonia (EVAC-PU-ETT) or a conventional, polyvinylchloride-cuffed endotracheal tube (PVC-ETT).

The National Heart, Lung, and Blood Institute of the National Institutes of Health (NIH) is funding this study.

Study Setting

The PreVent 2 Study will enroll patients who require emergency placement of a breathing tube at Yale New Haven Hospital. The decision to place the breathing tube will be made by the caregivers and is not affected by the study. When a patient requires the insertion of a breathing tube, they can receive either the specialized or the standard tube. However, since insertion of the breathing tube will occur in an emergency, in most cases patients will not be initially asked for informed consent to participate in a research study. The research team will review hospital reports twice a day to identify eligible patients. This study will enroll participants for approximately 24 months.

Study Procedures

Each patient will be randomly assigned (like flipping a coin) to one of the two types of ETTs, the regular tube or the special tube. The research team will follow patients’ care daily to see if symptoms of pneumonia develop. When the breathing tube is removed before leaving the hospital, the research team will review their medical record to see if there is any evidence of injury or safety issues. The research team will record details about past medical history and current illness from the medical record. We will also record the time the patient spent on the breathing machine, time in the ICU, time in the hospital, and collect data from the patient’s medical record about their medical care for up to 6 months after the patient is discharged from the hospital. Patients will be contacted at approximately six months after the breathing tube is inserted to see if quality of life or mental abilities are different, or if any other problems that might be related to the breathing tubes arise, after use of the specialized ETT compared to the standard ETT.