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Ultrasound Confirmation of Endotracheal Tube Location Using a Saline Filled Cuff (ET_Tube)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02131974
Recruitment Status : Completed
First Posted : May 6, 2014
Last Update Posted : October 12, 2018
Sponsor:
Information provided by (Responsible Party):
The University of Texas Health Science Center, Houston

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.


Condition or disease
Pediatric Endotracheal Intubation (no Specific Condition)

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.

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Study Type : Observational
Actual Enrollment : 92 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Ultrasound Confirmation of Endotracheal Tube Location Using a Saline Filled Cuff
Actual Study Start Date : October 22, 2013
Actual Primary Completion Date : October 10, 2014
Actual Study Completion Date : October 10, 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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 Outcome Measures:
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients scheduled to undergo elective cardiac catherization procedures will be screened for 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02131974


Locations
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United States, Texas
Children's Memorial Hermann Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Publications:

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Responsible Party: The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT02131974    
Other Study ID Numbers: HSC-MS-13-0324
First Posted: May 6, 2014    Key Record Dates
Last Update Posted: October 12, 2018
Last Verified: October 2018
Keywords provided by The University of Texas Health Science Center, Houston:
intubation, pediatric, endotracheal, cuffed ETT