Clinical trial NCT02131974: Ultrasound Confirmation of Endotracheal Tube Location Using a Saline Filled Cuff
Official title: Ultrasound Confirmation of Endotracheal Tube Location Using a Saline Filled Cuff
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pediatric Endotracheal Intubation (no Specific Condition)
Keywords: intubation, pediatric, endotracheal, cuffed ETT
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2014-05-06
Enrollment: 92
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients scheduled to undergo elective cardiac catherization procedures will be screened for eligibility.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Reliability of Ultrasound
timeFrame: 10 minutes
Secondary outcomes:
measure: Reliability of visualizing the cuff in patients without initial visualized cuff
timeFrame: 10 minutes
Other outcomes:
measure: Visualization of saline filled cuff
timeFrame: 10 minutes
Locations:
city: Houston
country: United States
facility: Children's Memorial Hermann Hospital
state: Texas
Study officials:
References:
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