Ultrasound-detectable Endotracheal Tube: a Feasibility Study

Cardiac Catheterization Clinical Trial

Official title:

Ultrasound-detectable Endotracheal Tube: a Feasibility Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05941013
• Other study ID #: HUM00234901
• Status: Recruiting
• Phase: N/A
• Start date: November 15, 2023
• Est. completion date: March 2025

Study information

• Verified date: March 2024
• Source: University of Michigan
• Contact: Cynthia Smith, RN
• Phone: 734-615-0590
• Email: csmithw[@]med.umich.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: March 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 42 Months

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Catheterization
• Endotracheal Tube

Intervention

Device:
• Ultrasound detectable cuffed endotracheal tube (USD-ETT)
Intubation with a novel ultrasound-detectable endotracheal tube

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
John R. Charpie

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Adverse events that could be related to the USD-ETT device		Up to 30 days post intubation
Secondary	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
Secondary	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