Cuff Techniques for Preventing Aspiration
(DICEE Trial)
Trial Summary
What is the purpose of this trial?
General anesthesia is a treatment with medicine to make a patient unconscious for surgery. This is sometimes called "being put to sleep" or "being put under." Most of the time, a breathing tube is used to help a machine breathe for patients. The breathing tube has a cuff, which is like a small balloon. After the breathing tube is placed, the cuff is inflated. This keeps the breathing tube in place and keeps fluids like saliva and stomach juices from getting into the windpipe and lungs. When a breathing tube is removed, that is called extubation.Normally, doctors deflate the cuff before removing the breathing tube. This is called deflated cuff extubation. Some doctors worry that keeping the cuff inflated while it is removed can damage the throat or vocal cords. However, some doctors keep the cuff inflated when removing the breathing tube. This is called inflated cuff extubation. These doctors think that keeping the cuff inflated can help keep fluids from entering the airway.Doctors have not studied if deflated cuff extubation is better or worse than inflated cuff extubation. The goal of this study is to see which type of extubation is better at keeping fluids from getting in the airway.Participants who are part of this study will get general anesthesia and have surgery as planned. Near the end of surgery, a small amount of liquid is placed at the back of a participant's mouth. This liquid is called contrast material, and it is like a dye. The contrast material will help determine if any liquid enters the windpipe or lungs. Then, contrast material is removed, along with any other fluids, using normal methods.When it is safe to take the breathing tube out, a deflated cuff extubation or an inflated cuff extubation will be performed. This decision will be made at random, like by the flip of a coin. Information will be collected about participants, the surgery, and how well a participant is breathing. After surgery, a chest x-ray will be taken to see if any of the contrast material is in the windpipe or lungs. Otherwise, everything else after surgery would be normal. 24 to 48 hours after surgery, a member of the research team will ask about any symptoms a participant may have, like sore throat or a hoarse voice. Research would conclude at that time.
Eligibility Criteria
This trial is for adults aged 18-50, scheduled for non-airway/head/neck surgery under 3 hours with an ASA status of 1-3. Excluded are those with certain lung diseases, anesthesia complications history, contrast agent allergies, difficult airways, improper fasting before surgery, pregnancy or participation in other related studies.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo scheduled non-airway surgery with either deflated or inflated cuff endotracheal extubation
Immediate Postoperative Monitoring
Participants are monitored for airway contamination and other respiratory parameters immediately after extubation
Follow-up
Participants are assessed for symptoms such as sore throat, voice quality, and dysphagia
Treatment Details
Interventions
- Deflated Cuff Extubation
- Inflated Cuff Extubation
Find a Clinic Near You
Who Is Running the Clinical Trial?
Naval Medical Center Camp Lejeune
Lead Sponsor