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).
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
20
Intubation with a novel ultrasound-detectable endotracheal tube
University of Michigan
Ann Arbor, Michigan, United States
RECRUITINGProportion 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.
Time frame: Within 5 minutes of placing the ultrasound probe at the suprasternal notch after intubation
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
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
Time frame: 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
Time frame: Approximately 5 minutes after of placing the ultrasound probe at the suprasternal notch after intubation
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