Ultrasound-detectable Endotracheal Tube: a Feasibility Study

Not Applicable

Recruiting

• Conditions: Cardiac Catheterization; Endotracheal Tube
• Interventions: Device: Ultrasound detectable cuffed endotracheal tube (USD-ETT)

• Registration Number: NCT05941013
• Lead Sponsor: John R. Charpie

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).

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 Timeline

• Study First Submitted: 2023-05-31
• Study First Submitted QC: 2023-07-08
• Study First Posted: 2023-07-12
• Study Start: 2023-11-15
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-27
• Last Update Posted: 2025-01-29
• Primary Completion: 2026-03
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ultrasound detectable cuffed endotracheal tube (USD-ETT)	Ultrasound detectable cuffed endotracheal tube (USD-ETT)	Intubation with a novel ultrasound-detectable endotracheal tube

Primary Outcome Measures

Name	Time	Method
Proportion of the USD-ETTs visualized by ultrasound	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.

Secondary Outcome Measures

Name	Time	Method
Safely support ventilation and oxygenation of the patient during the procedure	Immediately following extubation	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
Kappa agreement between placement location of USD-ETT as assessed by ultrasound and fluoroscopy	Approximately 5 minutes after of placing the ultrasound probe at the suprasternal notch after intubation	Ultrasound location data compared to fluoroscopy location data using a weighted Kappa statistic
Adverse events that could be related to the USD-ETT device	Up to 30 days post intubation

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States