Cardiac Catheterization, Endotracheal Tube
Conditions
Keywords
Ultrasound, Intubation
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.
Interventions
DEVICEUltrasound detectable cuffed endotracheal tube (USD-ETT)
Intubation with a novel ultrasound-detectable endotracheal tube
Sponsors
John R. Charpie
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Masking description
The outcomes assessor is "blinded" for outcome measure 4. Specifically the protocol says, "After each case is completed, the fluoroscopic images and ultrasound images will be interpreted by independent study team members who are blinded to the results of the other test."
Eligibility
Sex/Gender
ALL
Age
6 Months to 42 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of the USD-ETTs visualized by ultrasound | 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
| Measure | Time frame | Description |
|---|---|---|
| Adverse events that could be related to the USD-ETT device | Up to 30 days post intubation | — |
| Safely support ventilation and oxygenation of the patient during the procedure | Immediately following extubation | 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 |
| 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 | Ultrasound location data compared to fluoroscopy location data using a weighted Kappa statistic |
Countries
United States
Contacts
CONTACTCynthia Smith, RN
CONTACTAndrea Les, PhD
PRINCIPAL_INVESTIGATORJohn Charpie, MD, PhD
University of Michigan
Outcome results
None listed