Ultrasound-detectable Endotracheal Tube: a Feasibility 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).
Conditions:
🦠 Cardiac Catheterization 🦠 Endotracheal Tube
🗓️ Study Start (Actual) 15 November 2023
🗓️ Primary Completion (Estimated) February 2025
✅ Study Completion (Estimated) March 2025
👥 Enrollment (Estimated) 20
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Ann Arbor, Michigan, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 6 Months to 42 Months (CHILD)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 31 May 2023
  • First Submitted that Met QC Criteria 8 July 2023
  • First Posted 12 July 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 19 March 2024
  • Last Update Posted 20 March 2024
  • Last Verified March 2024