Actively Recruiting
Ultrasound-detectable Endotracheal Tube: a Feasibility Study
Led by John R. Charpie · Updated on 2026-02-05
20
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying a new type of breathing tube designed to help healthcare providers see more clearly if the tube is placed correctly during procedures requiring general anesthesia. This investigational device features a balloon cuff at the end that has a special divot shape and is filled with saline instead of air. This study is a feasibility trial to evaluate this novel ultrasound-detectable endotracheal tube (USD-ETT), which has not been used in humans before. Participants will undergo intubation using the USD-ETT during scheduled or planned cardiac catheterization procedures under general anesthesia. The study focuses on using ultrasound to visualize the placement of the tube shortly after intubation by placing an ultrasound probe at the suprasternal notch. Researchers will monitor how often the tube is visible by ultrasound and compare ultrasound findings with fluoroscopy to assess placement accuracy. During the study, participants will be monitored for any adverse events related to the device for up to 30 days after intubation. Researchers will also check if ventilation and oxygenation are safely maintained after removing the tube. The primary outcome is the proportion of endotracheal tubes seen by ultrasound within five minutes of placing the probe. Participants will be involved in standard care procedures along with these additional ultrasound assessments.
CONDITIONS
Brief Title
Ultrasound-detectable Endotracheal Tube: a Feasibility Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient is undergoing scheduled or planned diagnostic or interventional cardiac catheterization with planned general anesthesia requiring endotracheal intubation.
You will not qualify if you...
- 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 or unable to be intubated with 3.5 mm, 4.0 mm, or 4.5 mm Inner Diameter USD-ETT due to size.
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single procedure day
Participants undergo intubation with a novel ultrasound-detectable endotracheal tube during a scheduled cardiac catheterization procedure.
1 procedure visit (in-person)
Duration - Up to 30 days post intubation
Participants are monitored for adverse events and device performance up to 30 days after intubation.
Follow-up visits as needed up to 30 days
Trial Site Locations
Total: 1 location
1
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
Research Team
C
Cynthia Smith, RN
A
Andrea Les, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DEVICE_FEASIBILITY
Number of Arms
1
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