Clinical trial Recruiting at 1 site Interventional Ages 6 Months to 42 Months

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 typeInterventional
Ages6 Months to 42 Months
SexAll
Enrollment20 (estimated)
SponsorUniversity of Michigan
Academic / other
Locations1 site (Ann Arbor, Michigan)
StatusRecruiting
StartedNovember 15, 2023
Main results expectedMarch 2027
Study endsApril 2027
Registry record updatedFebruary 5, 2026
Trial IDNCT05941013 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

  • University of Michigan
    Ann Arbor, Michigan, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.