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).

Study Overview

• Status: Recruiting
• Conditions: Cardiac Catheterization; Endotracheal Tube
• Intervention / Treatment: Device: Ultrasound detectable cuffed endotracheal tube (USD-ETT)

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 Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cynthia Smith, RN; Phone Number: 734-615-0590; Email: csmithw@med.umich.edu
• Study Contact Backup: Name: Andrea Les, PhD; Phone Number: 734-998-5585; Email: asles@med.umich.edu

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Recruiting
      • University of Michigan
      • Contact: Cynthia Smith, RN; Phone Number: 734-615-0590; Email: csmithw@med.umich.edu
      • Contact: Andrea Les, PhD; Phone Number: 734-998-5585; Email: asles@med.umich.edu
      • Principal Investigator: John Charpie, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ultrasound detectable cuffed endotracheal tube (USD-ETT); Intubation with a novel ultrasound-detectable endotracheal tube	Device: Ultrasound detectable cuffed endotracheal tube (USD-ETT); Intubation with a novel ultrasound-detectable endotracheal tube

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Within 5 minutes of placing the ultrasound probe at the suprasternal notch after intubation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events that could be related to the USD-ETT device		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	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	Approximately 5 minutes after of placing the ultrasound probe at the suprasternal notch after intubation

Collaborators and Investigators

• Sponsor: John R. Charpie
• Investigators: Principal Investigator: John Charpie, MD, PhD, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2023
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: May 31, 2023
• First Submitted That Met QC Criteria: July 8, 2023
• First Posted (Actual): July 12, 2023

Study Record Updates

• Last Update Posted (Actual): February 5, 2026
• Last Update Submitted That Met QC Criteria: February 3, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Ultrasound; Intubation
• Other Study ID Numbers: HUM00234901

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No