Ultrasound-detectable Endotracheal Tube: a Feasibility Study
Overview
- Phase
- Not Applicable
- Intervention
- Ultrasound detectable cuffed endotracheal tube (USD-ETT)
- Conditions
- Cardiac Catheterization
- Sponsor
- John R. Charpie
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Proportion of the USD-ETTs visualized by ultrasound
- Status
- Recruiting
- Last Updated
- 2 months ago
Overview
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.
Investigators
John R. Charpie
Professor of Pediatric Cardiology, Professor of Pediatrics
University of Michigan
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
Arms & Interventions
Ultrasound detectable cuffed endotracheal tube (USD-ETT)
Intubation with a novel ultrasound-detectable endotracheal tube
Intervention: Ultrasound detectable cuffed endotracheal tube (USD-ETT)
Outcomes
Primary Outcomes
Proportion of the USD-ETTs visualized by ultrasound
Time Frame: Within 5 minutes of placing the ultrasound probe at the suprasternal notch after intubation
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.
Secondary Outcomes
- Safely support ventilation and oxygenation of the patient during the procedure(Immediately following extubation)
- Kappa agreement between placement location of USD-ETT as assessed by ultrasound and fluoroscopy(Approximately 5 minutes after of placing the ultrasound probe at the suprasternal notch after intubation)
- Adverse events that could be related to the USD-ETT device(Up to 30 days post intubation)