Ultrasound-detectable Endotracheal Tube: a Feasibility Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-42
SponsorJohn R. Charpie
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient is undergoing scheduled or planned diagnostic or interventional cardiac catheterization with planned general anesthesia requiring endotracheal intubation.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Ultrasound detectable cuffed endotracheal tube (USD-ETT)
DeviceIntubation with a novel ultrasound-detectable endotracheal tube
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Ultrasound detectable cuffed endotracheal tube (USD-ETT)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Within 5 minutes of placing the ultrasound probe at the suprasternal notch after intubationSecondary outcomes
1
Adverse events that could be related to the USD-ETT device
Time frame
Up to 30 days post intubation2
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 extubation3
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 intubationSponsors and contacts
Click on the lead sponsor to view all of their trials.
John R. Charpie
Lead sponsor
University of Michigan
Sponsor institution
Source ClinicalTrials.gov