Ultrasound-detectable Endotracheal Tube: a Feasibility Study

John R. Charpie

Status: Enrolling

Conditions: Cardiac Catheterization; Endotracheal Tube

Treatments: Device: Ultrasound detectable cuffed endotracheal tube (USD-ETT)

Study type: Interventional

Funder types: Other

Identifiers

NCT05941013

HUM00234901

Details and patient eligibility

About

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).

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 6 to 42 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Ultrasound detectable cuffed endotracheal tube (USD-ETT)

Experimental group

Description:

Intubation with a novel ultrasound-detectable endotracheal tube

Treatment:

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