Recruiting

Observational Study

Sponsor:

John R. Charpie

Code:

NCT05941013

Conditions

Cardiac Catheterization

Endotracheal Tube

Eligibility Criteria

Sex: All

Age: 0 - 3

Healthy Volunteers: Not accepted

Interventions

Ultrasound detectable cuffed endotracheal tube (USD-ETT)

Study Details

Brief 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).

Conditions

Cardiac Catheterization

Endotracheal Tube

Study ID

NCT05941013

Start date

Nov 15, 2023

Status verified date

Feb, 2026

Completion date

Apr, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 3

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Arms

experimental: Ultrasound detectable cuffed endotracheal tube (USD-ETT)

Intubation with a novel ultrasound-detectable endotracheal tube

Interventions

Ultrasound detectable cuffed endotracheal tube (USD-ETT)

Intubation with a novel ultrasound-detectable endotracheal tube

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 ]

Central Contacts and Locations

Central contacts

Cynthia Smith, RN

734-615-0590csmithw@med.umich.edu

Andrea Les, PhD

734-998-5585asles@med.umich.edu

Locations

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Cynthia Smith, RN

734-615-0590csmithw@med.umich.edu

Andrea Les, PhD

734-998-5585asles@med.umich.edu

Principal Investigator:

John Charpie, MD, PhD

More Information

Sponsor

John R. Charpie

Last update posted

Feb 5, 2026

Last verified

Feb, 2026

Keywords

  • Ultrasound
  • Intubation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by John R. Charpie on 2026-02-05.