University of Michigan
Ann Arbor, Michigan, 48109, United States
Location status: Recruiting
Location contact
Andrea Les, PhD
CONTACT
Cynthia Smith, RN
CONTACT
John Charpie, MD, PhD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT05941013
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).
Interested in participating?
Request Info6 month–42 month
All sexes
Interventional
Not applicable
Ann Arbor, Michigan, 48109, United States
Location status: Recruiting
Andrea Les, PhD
CONTACT
Cynthia Smith, RN
CONTACT
John Charpie, MD, PhD
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Intubation with a novel ultrasound-detectable endotracheal tube
Time frame: 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.
Time frame: Up to 30 days post intubation
Time frame: 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
Time frame: 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
Contact information is provided by the study sponsor or research team.
Andrea Les, PhD
CONTACT
Cynthia Smith, RN
CONTACT
John R. Charpie
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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