Ultrasound-detectable Endotracheal Tube: a Feasibility Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ultrasound detectable cuffed endotracheal tube (USD-ETT).
- Who it may be relevant to
- Registry conditions: Cardiac Catheterization, Endotracheal Tube. Basic parameters: 6 months — 42 months · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Device Ultrasound detectable cuffed endotracheal tube (USD-ETT)
Intubation with a novel ultrasound-detectable endotracheal tube
Primary outcome measures
- Proportion of the USD-ETTs visualized by ultrasound [Time frame: Within 5 minutes of placing the ultrasound probe at the suprasternal notch after intubation]
Secondary outcome measures (3)
- Adverse events that could be related to the USD-ETT device [Time frame: Up to 30 days post intubation]
- Safely support ventilation and oxygenation of the patient during the procedure [Time frame: Immediately following extubation]
- Kappa agreement between placement location of USD-ETT as assessed by ultrasound and fluoroscopy [Time frame: Approximately 5 minutes after of placing the ultrasound probe at the suprasternal notch after intubation]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Device feasibility
Study locations
United States · 1 center
- University of Michigan — Ann Arbor
Identifiers
NCT: NCT05941013 · HUM00234901