Children's Memorial Hermann Hospital
Houston, Texas, 77030, United States
Completed
NCT Number: NCT02131974
Ultrasound Confirmation of Endotracheal Tube Location Using a Saline Filled Cuff
The purpose of this research study is to help determine if the cuff of an endotracheal tube ( ETT) ( also known as a breathing tube)can be seen by ultrasound and to determine if visualization of this tube corresponds with correct tube depth. You are being asked to participate because you will be undergoing a cardiac catherization procedure which will involve endotracheal intubation.
Ultrasound is a safe technology that your doctor could possibly use to see the breathing tube. Right now, x-rays, which come with their own risks, are being used for this purpose. We are trying to see if we can avoid using x-rays.
This is a local study with 1 location. The study will enroll a total of 71 people. There is no sponsor for this study.
Completed
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Notify MeKey information
Age range
Up to 21 year
Sex eligibility
All sexes
Study type
Observational
Primary location
About this study
If you enter the study, in the cardiac catheterization lab, after the anesthesiologist has done his part (placed the breathing tube while you are asleep and obtained the x-ray), we will use the ultrasound to check the position of the breathing tube. To help us see the breathing tube better, we will put some fluid in the cuff ( the balloon at the tip of the breathing tube). The tube may be repositioned as needed based on the chest x-ray. The entire procedure is estimated to take no more than 10 minutes.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- English and Spanish-speaking patients
- Age 0-21 years
- Elective cardiac catheterization procedure
- Endotracheal intubation with a cuffed ETT
Exclusion criteria
- Abnormal neck/tracheal anatomy
- Emergent cardiac catherization procedure
- Endotracheal intubation with an uncuffed ETT
- Inability to consent
Treatment and study plan
Primary outcomes
-
Reliability of Ultrasound
Time frame: 10 minutes
Determine the reliability of ultrasound in visualizing a saline-filled cuff of the ETT in pediatric patients.
Secondary outcomes
-
Reliability of visualizing the cuff in patients without initial visualized cuff
Time frame: 10 minutes
In patients without an initial visualized cuff, determine the reliability of ultrasound in visualizing the cuff after a single retraction of the tube (as deemed permissible by cinefluoroscopy).
Other outcomes
-
Visualization of saline filled cuff
Time frame: 10 minutes
Determine if visualization of a saline-filled cuff at the suprasternal notch corresponds with correct tube depth as determined by cinefluoroscopy.
Sponsors and collaborators
Lead sponsor
The University of Texas Health Science Center, Houston
Other
Registry information
Acronym: ET_Tube
Important dates
- Study start
- 2013
- Primary completion
- 2014
- Study completion
- 2014
- First posted
- May 6, 2014
- Registry last updated
- Oct 12, 2018
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.