Uncuffed breathing tube versus no breathing tube during EBUS-TBNA under moderate sedation
Comparison of Uncuffed Endotracheal Tube to no Endotracheal Tube in EBUS-TBNA Procedure Under Moderate Sedation
This will test whether using an uncuffed breathing tube during EBUS-TBNA with moderate sedation helps people tolerate the procedure better, shortens the procedure, reduces oxygen drops, or lowers sedative medication use.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Minnesota Academic / other |
| Locations | 1 site (Minneapolis, Minnesota) |
| Trial ID | NCT06799455 on ClinicalTrials.gov |
What this trial studies
This comparison enrolls patients scheduled for endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) and compares use of an uncuffed endotracheal tube to performing the procedure without a tube under moderate sedation. Participants undergo the procedure with standard monitoring and airway management per their assigned approach. The trial tracks patient tolerance, procedure duration, episodes of desaturation, and total sedative medication used. Data are collected during and immediately after the procedure to determine practical differences in safety, comfort, and efficiency.
Who should consider this trial
Good fit: Adults scheduled for EBUS-TBNA who are considered safe candidates for moderate sedation and flexible bronchoscopy.
Not a fit: Patients who cannot safely receive moderate sedation or undergo flexible bronchoscopy, or who require general anesthesia or alternative airway management, would not be expected to benefit.
Why it matters
Potential benefit: If successful, using an uncuffed tube could improve patient comfort and safety during EBUS-TBNA by reducing oxygen desaturation and sedative requirements and potentially shortening procedure time.
How similar studies have performed: Previous studies of airway adjuncts during bronchoscopic procedures have shown mixed results, and evidence specifically supporting uncuffed endotracheal tube use for EBUS-TBNA is limited and relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Any patient that is scheduled for EBUS-TBNA procedure Exclusion Criteria: * Those who are not safe to receive moderate sedation or flexible bronchoscopy
Where this trial is running
Minneapolis, Minnesota
- University of Minnesota — Minneapolis, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: H. Erhan Dincer — University of Minnesota
- Study coordinator: Jamie Heisdorffer
- Email: curre024@umn.edu
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.