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
Who Is on the Research Team?
Michael A Lee, MD
Principal Investigator
Naval Medical Center Camp Lejeune
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
Trial Overview
The study compares deflated cuff extubation (normal method) and inflated cuff extubation (cuff remains inflated) to see which better prevents fluids from entering the airway after general anesthesia. Participants will be randomly assigned one of these methods during surgery recovery.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Extubation with an inflated endotracheal tube cuff
Extubation with a deflated endotracheal tube cuff
Find a Clinic Near You
Who Is Running the Clinical Trial?
Naval Medical Center Camp Lejeune
Lead Sponsor
Citations
Could "safe practice" be compromising ...
By contrast, keeping the cuff inflated during extubation will minimize the risk of tracheal aspiration around the ETT, and it will reliably ...
Deflated and Inflated Cuff Endotracheal Extubations
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 ...
the effects of extubation with an inflated versus deflated ...
This study confirmed that extubation with an inflated HPLV ETT cuff was effective in removing intratracheal contrast. However, other ...
Comparison between Two Endotracheal Tube Cuff Inflation ...
The incidence of post extubation sore throat was 54% (27 in 50) in the JS group and only 12% (6 in 50) in the SG; p= 0.00000797. Conclusion. ETT cuff inflation ...
Minimal occlusive volume cuff inflation: A survey of current ...
Survey response was 71% (80/113). Three methods of MOV were identified. Full cuff deflation, followed by reinflation, removal of 1 mL increments of air ...
Unveiling the significance of cuff pressure in anaesthesia
Underinflated cuffs may compromise the seal between the tracheal tube and the trachea, increasing the risk of microaspiration of oropharyngeal secretions.
Positive- vs. negative-pressure extubation technique
The current literature suggests that PPET is as safe as NPET and may lead to better clinical outcomes, including stable vital signs, improved ...
Effectiveness and safety of endotracheal tube cuffs filled ...
High intracuff pressure in endotracheal tubes (ETs) may cause tracheal lesions. The aim of this study was to evaluate the effectiveness and safety of ...
Extubation techniques in anaesthesia—a narrative review
The aim of this review article was to look at the available current evidence, guidelines and expert opinions on extubation to help provide a summary of risk ...
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