Ultrasound-detectable Endotracheal Tube: a Feasibility Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Ultrasound-detectable Endotracheal Tube: a Feasibility Study

Conditions
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Cardiac Catheterization, Endotracheal Tube

Intervention / Treatment
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* Device: Ultrasound detectable cuffed endotracheal tube (USD-ETT)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 42 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ultrasound detectable cuffed endotracheal tube (USD-ETT)<br>Intubation with a novel ultrasound-detectable endotracheal tube | Device: Ultrasound detectable cuffed endotracheal tube (USD-ETT)<br>* Intubation with a novel ultrasound-detectable endotracheal tube<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events that could be related to the USD-ETT device |  | Up to 30 days post intubation | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ultrasound, Intubation