200 Participants Needed

Uncuffed Endotracheal Tube for Lung Disease

JH
Overseen ByJamie Heisdorffer
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Minnesota
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether using an uncuffed endotracheal tube (a tube that aids breathing without a cuff for securing) can enhance comfort and efficiency in certain lung procedures compared to not using a tube. The trial focuses on patient tolerance, procedure duration, and sedation levels. It targets individuals scheduled for a specific lung procedure called EBUS-TBNA, which uses a special ultrasound to check for lung diseases. This trial may suit those set for this procedure and able to safely receive moderate sedation. As an unphased trial, it offers a unique opportunity to contribute to medical knowledge and potentially improve lung procedure experiences.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the uncuffed endotracheal tube is safe for use in the EBUS-TBNA procedure?

Research shows that uncuffed endotracheal tubes (UCETTs) are often used in medical procedures, especially for children. Studies have found that UCETTs are generally as safe as cuffed tubes. Both types have similar side effects after surgery, although UCETTs carry a slightly higher risk of causing post-extubation croup, which is swelling in the throat.

Other research indicates that cuffed tubes might offer advantages, such as reducing air leaks and preventing fluids from entering the lungs. However, UCETTs remain safe for certain procedures. UCETTs have been used for a long time and are usually well-tolerated. While some studies highlight possible downsides, UCETTs continue to be effectively used in many situations.12345

Why are researchers excited about this trial?

Unlike the standard of care for lung disease, which often involves the use of cuffed endotracheal tubes, the uncuffed endotracheal tube offers a unique approach. Traditional cuffed tubes create a seal to prevent air leakage, but they can sometimes cause damage to the delicate tissues of the airway. The uncuffed tube aims to minimize this risk by eliminating the cuff, potentially reducing airway trauma and improving patient comfort. Researchers are excited about this trial because it could lead to a safer, less invasive option for managing lung disease, especially in vulnerable populations like children.

What evidence suggests that the uncuffed endotracheal tube is effective for lung disease?

This trial will compare the use of uncuffed endotracheal tubes (UCETT) with no endotracheal tube in patients with lung disease. Research on UCETT has shown mixed results. In young patients, studies indicate no significant difference in safety or breathing problems between cuffed and uncuffed tubes. However, some findings suggest that cuffed tubes might better maintain lung inflation than uncuffed ones. Without a clear standard or consensus on using cuffed versus uncuffed tubes, the choice often depends on the specific situation and patient needs. Initial studies suggest UCETT can be used safely, but more research is needed to confirm its effectiveness in specific procedures like EBUS-TBNA.16789

Who Is on the Research Team?

HE

H. Erhan Dincer

Principal Investigator

University of Minnesota

Are You a Good Fit for This Trial?

This trial is for patients scheduled for an EBUS-TBNA procedure, which is a type of lung biopsy. There are no specific exclusion criteria provided, so it appears open to all individuals who are planned to undergo this procedure.

Inclusion Criteria

I am scheduled for an EBUS-TBNA procedure.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Procedure

Participants undergo the EBUS-TBNA procedure with either an uncuffed endotracheal tube or no endotracheal tube under moderate sedation

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the procedure

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Uncuffed Endotracheal Tube
Trial Overview The study compares using an uncuffed endotracheal tube (UCETT) versus not using any tube during the EBUS-TBNA procedure. It looks at how well patients tolerate the process, its duration, oxygen levels in blood (desaturation), and sedative medication needed.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: uncuffed endotracheal groupExperimental Treatment1 Intervention
Group II: no endotracheal tube group/controlActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials
1,459
Recruited
1,623,000+

Citations

Respiratory Complications Between Cuffed and Uncuffed ...Objective To study effectiveness and safety of cuffed versus uncuffed endotracheal tubes (ETTs) in small infants in the intensive care unit (ICU) ...
Pediatric Anesthesia: Cuffed vs. Uncuffed ET TubesThe use of cuffed ETT ranged between 11%-61% in the included studies and all reported that there were no consensus or standard on whether cuffed or uncuffed ETT ...
Cuffed versus uncuffed endotracheal tubes for neonatesThe meta‐analysis showed no difference between cuffed and uncuffed ETT in postextubation stridor, reintubation rate, or duration of mechanical ...
4.associationofanaesthetists-publications.onlinelibrary.wiley.comassociationofanaesthetists-publications.onlinelibrary.wiley.com/doi/10.1111/anae.14113
Cuffed vs. uncuffed tracheal tubes in children: a randomised ...These findings suggest that there is superior maintenance of lung volume in the cuffed TT group and reduction of lung volume in the uncuffed TT ...
Uncuffed Endotracheal Tube for Lung DiseaseThis N/A medical study run by University of Minnesota is evaluating whether Uncuffed Endotracheal Tube will have tolerable side effects & efficacy for ...
Not Appropriate for Pediatric Critical Care TransportHistorically, uncuffed endotracheal tubes have been recommended for use in pediatric patients based on an antiquated study and limitations of endotracheal ...
7.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/38922733/
Cuffed versus uncuffed endotracheal tubes in neonates ...Postoperative adverse events were comparable between both groups except for significantly higher post extubation croup in the uncuffed ETT group ...
Uncuffed Endotracheal Tube Experience in Pediatric ...A cuffed ETT is preferred for many reasons, such as reducing the risk of aspiration, reducing air leakage, and preventing environmental ...
Cuffed vs Uncuffed Endotracheal Tubes for Pediatric PatientsWith this, there is growing evidence that suggests uncuffed ETTs may not have better outcomes that truly offers an advantage over cuffed tubes, ...
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