Cardiac CatheterizationNCT05941013
Ultrasound-detectable Endotracheal Tube: a Feasibility Study
A study testing Ultrasound detectable cuffed endotracheal tube (USD-ETT) in people with Cardiac Catheterization and Endotracheal Tube, run by John R. Charpie at 1 site in United States.
Trial summary
The researchers are studying whether special features make it easier to see if the breathing tube is in the correct place. It is hoped that the investigational device will enable more accurate placement (depth and trachea vs. esophagus). Read more about this study
- Who is it for?
- Ages 6 to 42 months
- Conditions the study is for
- Cardiac Catheterization, Endotracheal Tube
- What is being tested?
- Ultrasound detectable cuffed endotracheal tube (USD-ETT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2023to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 42 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patient is undergoing scheduled or planned diagnostic or interventional cardiac catheterization with planned general anesthesia requiring endotracheal intubation.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Cynthia Smith, RN, 734-615-0590, csmithw@med.umich.edu
Andrea Les, PhD, 734-998-5585, asles@med.umich.edu
About this study
The researchers are studying whether special features make it easier to see if the breathing tube is in the correct place. It is hoped that the investigational device will enable more accurate placement (depth and trachea vs. esophagus).
Read the detailed description
The participant will have a breathing tube where the balloon (cuff) at the end of the tube has two special features: 1) The balloon will have a divot in it, rather than be round in shape, and 2) The balloon will be filled with saline (salt water), rather than air. The breathing tube is called an ultrasound detectable cuffed endotracheal tube (USD-ETT).
The USD-ETT has not been tested or used in humans previously.
- Conditions
- Cardiac Catheterization, Endotracheal Tube
- Being tested
- Ultrasound detectable cuffed endotracheal tube (USD-ETT)
- Keywords
- Ultrasound, Intubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound detectable cuffed endotracheal tube (USD-ETT)Device
Intubation with a novel ultrasound-detectable endotracheal tube
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound detectable cuffed endotracheal tube (USD-ETT) | Experimental | Intubation with a novel ultrasound-detectable endotracheal tube Receives: Device: Ultrasound detectable cuffed endotracheal tube (USD-ETT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of the USD-ETTs visualized by ultrasound
Reported as a 'yes' or 'no' - this outcome simply seeks to verify if the ultrasound can detect the ultrasound detectable cuffed endotracheal tube. The outcome measure assesses if the device is detectable as designed. It does not assess health related information.
Measured: Within 5 minutes of placing the ultrasound probe at the suprasternal notch after intubation
Secondary outcomes (3)
Adverse events that could be related to the USD-ETT device
Measured: Up to 30 days post intubation
Safely support ventilation and oxygenation of the patient during the procedure
Assessed by the question: "Were there any desaturation events, inability to property ventilate the patient or, blood gas abnormalities, that could be attributable to the ETT?" will be described
Measured: Immediately following extubation
Kappa agreement between placement location of USD-ETT as assessed by ultrasound and fluoroscopy
Ultrasound location data compared to fluoroscopy location data using a weighted Kappa statistic
Measured: Approximately 5 minutes after of placing the ultrasound probe at the suprasternal notch after intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2023
- Study start15 Nov 2023
- Primary completionMar 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac CatheterizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- John R. Charpie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, John R. Charpie, University of Michigan
- Investigators
- John Charpie, MD, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05941013
- Sponsor's protocol ID
- HUM00234901
- Status last verified
- Feb 2026
- First submitted
- 31 May 2023
- Last updated
- 5 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-detectable Endotracheal Tube: a Feasibility Study
- ClinicalTrials.gov ID
- NCT05941013
- Acronym / sponsor ID
- HUM00234901
- Conditions
- Cardiac Catheterization, Endotracheal Tube
- Keywords
- Ultrasound, Intubation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- John R. CharpieUniversity, hospital or other
- Study start
- 15 Nov 2023 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 12 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The researchers are studying whether special features make it easier to see if the breathing tube is in the correct place. It is hoped that the investigational device will enable more accurate placement (depth and trachea vs. esophagus).
Detailed description
The participant will have a breathing tube where the balloon (cuff) at the end of the tube has two special features: 1) The balloon will have a divot in it, rather than be round in shape, and 2) The balloon will be filled with saline (salt water), rather than air. The breathing tube is called an ultrasound detectable cuffed endotracheal tube (USD-ETT).
The USD-ETT has not been tested or used in humans previously.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ultrasound detectable cuffed endotracheal tube (USD-ETT) | Experimental | Device: Ultrasound detectable cuffed endotracheal tube (USD-ETT)Intubation with a novel ultrasound-detectable endotracheal tube |
Who may qualify
- Ages
- 6 to 42 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Patient is undergoing scheduled or planned diagnostic or interventional cardiac catheterization with planned general anesthesia requiring endotracheal intubation.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound detectable cuffed endotracheal tube (USD-ETT)Intubation with a novel ultrasound-detectable endotracheal tube | Device | Ultrasound detectable cuffed endotracheal tube (USD-ETT) |
Primary outcome
Proportion of the USD-ETTs visualized by ultrasound
Time frame: Within 5 minutes of placing the ultrasound probe at the suprasternal notch after intubation
Reported as a 'yes' or 'no' - this outcome simply seeks to verify if the ultrasound can detect the ultrasound detectable cuffed endotracheal tube. The outcome measure assesses if the device is detectable as designed. It does not assess health related information.
3 secondary outcomes
Adverse events that could be related to the USD-ETT device
Time frame: Up to 30 days post intubation
Safely support ventilation and oxygenation of the patient during the procedure
Time frame: Immediately following extubation
Kappa agreement between placement location of USD-ETT as assessed by ultrasound and fluoroscopy
Time frame: Approximately 5 minutes after of placing the ultrasound probe at the suprasternal notch after intubation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
John Charpie, MD, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound detectable cuffed endotracheal tube (USD-ETT) in people with Cardiac Catheterization and Endotracheal Tube, run by John R. Charpie at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cynthia Smith, RN (734-615-0590, csmithw@med.umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of the USD-ETTs visualized by ultrasound (time frame: Within 5 minutes of placing the ultrasound probe at the suprasternal notch after intubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.