Ultrasound-detectable Endotracheal Tube: a Feasibility Study

Launched by JOHN R. CHARPIE · Jul 8, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at a new type of breathing tube, called the ultrasound-detectable endotracheal tube, to see if it can help doctors place the tube more accurately during heart procedures. The goal is to make sure the tube is correctly positioned in the windpipe (trachea) instead of the food pipe (esophagus), which is very important for patient safety during anesthesia.

To be eligible for this study, patients need to be scheduled for a heart procedure that requires general anesthesia and endotracheal intubation (the process of placing a breathing tube). However, certain patients are not eligible, including those with specific airway problems, those who already have a tracheostomy, or those who may have a difficult time being intubated. If you decide to participate, you can expect close monitoring and care from the medical team during your procedure. This study is currently recruiting participants of all genders, aged 18 to 127 years old, who meet the criteria.

Gender

ALL

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