Using a special breathing tube to improve intubation accuracy
Official title: Ultrasound-detectable Endotracheal Tube: a Feasibility Study
Run by University of Michigan · NCT05941013 · Data updated 2026-11-12
This study is testing a new type of breathing tube to see if it helps doctors place the tube more accurately during heart procedures.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 6 Months to 42 Months |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | University of Michigan Academic / other |
| Locations | 1 site (Ann Arbor, Michigan) |
| Status | Recruiting |
| Started | November 15, 2023 |
| Main results expected | March 2027 |
| Study ends | April 2027 |
| Registry record updated | February 5, 2026 |
| Trial ID | NCT05941013 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients scheduled for diagnostic or interventional cardiac catheterization requiring general anesthesia and endotracheal intubation.
✕Probably not a fit
Patients with known airway abnormalities, tracheostomy, or those who are ventilator-dependent will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the feasibility of an ultrasound-detectable cuffed endotracheal tube (USD-ETT) designed to enhance the accuracy of intubation during cardiac catheterization procedures. The USD-ETT features a uniquely shaped balloon with a divot and is filled with saline instead of air, which may improve visibility and placement confirmation. Participants undergoing general anesthesia for cardiac catheterization will be monitored to assess the effectiveness of this innovative device in ensuring correct tube placement in the trachea versus the esophagus.
Why it matters
Potential benefit: If successful, this device could significantly reduce the risk of misplacement during intubation, leading to safer anesthesia practices.
How similar studies have gone: This approach is novel and has not been tested in humans previously, making it an exploratory endeavor.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient is undergoing scheduled or planned diagnostic or interventional cardiac catheterization with planned general anesthesia requiring endotracheal intubation. Exclusion Criteria: * Patient has a known airway abnormality, including tracheal stenosis, previous tracheal stenosis, or tracheobronchomalacia. * Patient has a tracheostomy. * Patient is ventilator-dependent. * Patient has an anticipated difficult intubation based upon airway exam and/or history of difficult intubation. * Patient is unlikely (in opinion of anesthesia team) or is unable to be intubated with 3.5 mm, 4.0 mm, or 4.5 mm Inner Diameter USD-ETT due to the size of the patient or their airway. * Patient is already intubated prior to the scheduled procedure. * It is anticipated that the patient will not be extubated after the catheterization procedure. * Concurrent enrollment in another clinical trial with an intervention during the cardiac catheterization procedure or 30 days afterwards. * Allergy to plastic/materials in USD-ETT
Where it's running
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University of Michigan
Ann Arbor, Michigan, United States Recruiting
Study contacts
- Principal investigator: John Charpie, MD, PhD — University of Michigan
- Study coordinator: Cynthia Smith, RN
- Email: csmithw@med.umich.edu
- Phone: 734-615-0590
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.