Clinical trial NCT05941013: Ultrasound-detectable Endotracheal Tube: a Feasibility Study
Official title: Ultrasound-detectable Endotracheal Tube: a Feasibility Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiac Catheterization
Endotracheal Tube
Keywords: Ultrasound
Intubation
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2023-07-12
Enrollment: 20
Sex: ALL
Minimum age (years): 6
Maximum age (years): 42
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of the USD-ETTs visualized by ultrasound
timeFrame: Within 5 minutes of placing the ultrasound probe at the suprasternal notch after intubation
Secondary outcomes:
measure: Adverse events that could be related to the USD-ETT device
timeFrame: Up to 30 days post intubation
measure: Safely support ventilation and oxygenation of the patient during the procedure
timeFrame: Immediately following extubation
measure: Kappa agreement between placement location of USD-ETT as assessed by ultrasound and fluoroscopy
timeFrame: Approximately 5 minutes after of placing the ultrasound probe at the suprasternal notch after intubation
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: John Charpie, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: