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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ultrasound detectable cuffed endotracheal tube (USD-ETT) | Experimental | Intubation with a novel ultrasound-detectable endotracheal tube |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasound detectable cuffed endotracheal tube (USD-ETT) | Device | Intubation with a novel ultrasound-detectable endotracheal tube |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Within 5 minutes of placing the ultrasound probe at the suprasternal notch after intubation |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cynthia Smith, RN | Contact | 734-615-0590 | csmithw@med.umich.edu | |
| Andrea Les, PhD | Contact | 734-998-5585 | asles@med.umich.edu |
| Name | Affiliation | Role |
|---|---|---|
| John Charpie, MD, PhD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Recruiting | Ann Arbor | Michigan | 48109 | United States |
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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."
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| 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 | Approximately 5 minutes after of placing the ultrasound probe at the suprasternal notch after intubation |