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

October 9, 2018 updated by: The University of Texas Health Science Center, Houston

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

92

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Children's Memorial Hermann Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 21 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients scheduled to undergo elective cardiac catherization procedures will be screened for eligibility.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reliability of Ultrasound
Time Frame: 10 minutes
Determine the reliability of ultrasound in visualizing a saline-filled cuff of the ETT in pediatric patients.
10 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
10 minutes

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
10 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center, Houston

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 22, 2013

Primary Completion (Actual)

October 10, 2014

Study Completion (Actual)

October 10, 2014

Study Registration Dates

First Submitted

May 2, 2014

First Submitted That Met QC Criteria

May 2, 2014

First Posted (Estimate)

May 6, 2014

Study Record Updates

Last Update Posted (Actual)

October 12, 2018

Last Update Submitted That Met QC Criteria

October 9, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HSC-MS-13-0324

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe