Cuff Techniques for Preventing Aspiration
(DICEE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine whether keeping the cuff of a breathing tube inflated or deflated during removal after surgery better prevents fluids from entering the windpipe and lungs. Participants will receive general anesthesia for their scheduled surgery, and a special liquid will be placed in their throat to check for fluid entry into the airway. After surgery, a chest x-ray will determine if the liquid has entered the windpipe or lungs. The trial seeks adults scheduled for non-airway surgeries expected to last under three hours, excluding those with certain conditions like uncontrolled asthma or recent pneumonia. Participants will be monitored for symptoms such as a sore throat or hoarse voice for up to 48 hours post-surgery. As an unphased trial, this study aims to enhance surgical safety, allowing participants to contribute to significant medical research.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the research team or your doctor.
What prior data suggests that these cuff techniques are safe for extubation?
Research has shown that keeping the breathing tube's cuff inflated during removal might help prevent fluids from entering the airway. Some studies suggest this method can be as safe as deflating the cuff before tube removal. However, concerns exist that removing the tube with the cuff still inflated might harm the throat or vocal cords, and high pressure in the cuff could injure the windpipe.
Conversely, the traditional method involves deflating the cuff before removing the tube. This approach is commonly used and generally considered safe, but it might increase the risk of fluids entering the airway.
Both methods are widely used, and this study aims to determine which one better prevents fluids from entering the lungs. Participants in this study will contribute valuable information on the safety and effectiveness of these two methods.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it investigates different techniques for extubation—removing a breathing tube—aimed at preventing aspiration, which is when food or liquid accidentally enters the airway. The trial compares deflated cuff extubation and inflated cuff extubation. Typically, the cuff on an endotracheal tube is deflated before removal to allow for easier passage, but this trial explores the potential benefits of keeping the cuff inflated during extubation. By evaluating these methods, researchers hope to find if one approach reduces the risk of aspiration more effectively than the other, potentially leading to safer extubation practices.
What evidence suggests that this trial's extubation techniques could be effective for preventing aspiration?
This trial will compare two extubation techniques: Inflated Cuff Extubation and Deflated Cuff Extubation. Research has shown that keeping the cuff inflated during tube removal can reduce the risk of fluids entering the airway. This method helps clear fluids from the windpipe and may prevent tracheal aspiration, which occurs when food or liquid accidentally enters the windpipe or lungs. However, some doctors worry that removing the tube with the cuff inflated might harm the throat or vocal cords. Despite these concerns, evidence suggests it can effectively prevent fluids from entering the lungs.16789
Are You a Good Fit for This Trial?
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 for a Trial Participant
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
What Are the Treatments Tested in This Trial?
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