RecruitingNot ApplicableNCT05941013

Ultrasound-detectable Endotracheal Tube: a Feasibility Study

Sponsor

John R. Charpie

Enrollment

20 participants

Start Date

Nov 15, 2023

Study Type

INTERVENTIONAL

Conditions

Endotracheal Tube Cardiac Catheterization

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).

Eligibility

Min Age: 6 MonthsMax Age: 42 Months

Inclusion Criteria1

Patient is undergoing scheduled or planned diagnostic or interventional cardiac catheterization with planned general anesthesia requiring endotracheal intubation.

Exclusion Criteria9

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

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