Using a special breathing tube to improve intubation accuracy
Ultrasound-detectable Endotracheal Tube: a Feasibility Study
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 6 Months to 42 Months |
| Sex | All |
| Sponsor | University of Michigan Academic / other |
| Locations | 1 site (Ann Arbor, Michigan) |
| Trial ID | NCT05941013 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are patients scheduled for diagnostic or interventional cardiac catheterization requiring general anesthesia and endotracheal intubation.
Not a fit: Patients with known airway abnormalities, tracheostomy, or those who are ventilator-dependent will not benefit from this study.
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 performed: This approach is novel and has not been tested in humans previously, making it an exploratory endeavor.
Eligibility criteria
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 this trial is running
Ann Arbor, Michigan
- 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
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.