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Ultrasound Evaluation of Endotracheal Tube Depth

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ClinicalTrials.gov Identifier: NCT01649882
Recruitment Status : Unknown
Verified May 2015 by Kai Schoenhage, University of Arizona.
Recruitment status was:  Recruiting
First Posted : July 25, 2012
Last Update Posted : June 2, 2015
Sponsor:
Information provided by (Responsible Party):
Kai Schoenhage, University of Arizona

Brief Summary:

Correct positioning of the endotracheal tube (ETT) is crucial to ensure safe ventilation. To date, no test that can verify this right after intubation at the bedside exists. Indirect tests have false negative and positive results leading to complications or at least difficulties in performing effective ventilation of patients.

Bedside ultrasound could fill this need. Although bedside ultrasound may not be possible or useful in routine intubations, it may prove useful in difficult or questionable cases, where current clinical exams/techniques may not offer a reliable indication of endotracheal tube depth.


Condition or disease Intervention/treatment Phase
Intubation, Intratracheal Procedure: US ETT (ultrasound endotracheal tube) Not Applicable

Detailed Description:

Ultrasound is able to visualize some parts of the trachea and the ETT therein and although the actual structures of interest (ETT tip and carina) are difficult or impossible to visualize reliably (due to their air contents reflecting ultrasound beams) one can use surrogates:

The cuff of the ETT can be visualized as it is in- or deflated or it can be filled with an air-fluid(saline) mixture to delineate it inside the trachea.

For the same reason (air reflecting ultrasound beams) the carina is difficult to visualize and one can use the aortic arch which is positioned just anterior to it instead.

This study apart from determining feasibility of the method may produce enough data from ultrasound exams to develop/derive a more pre-cise algorithm than available today aiding in positioning the endotracheal tube in regards to anatomic-al landmarks (teeth, gums, lips) even without the use of ultrasound.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Ultrasound Evaluation of Endotracheal Tube Depth for Proper Tube Placement in Different Patient Groups
Study Start Date : July 2012
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
Experimental: US ETT (ultrasound endotracheal tube)
Subjects will have a brief (< 15 minutes) ultrasound exam of the neck after intubation. The cuff of the endotracheal tube as well as the aortic arch will be identified. The distance between the two structures will be measured and recorded.
Procedure: US ETT (ultrasound endotracheal tube)
Subjects will have a brief (< 15 minutes) ultrasound exam of the neck after intubation. The cuff of the endotracheal tube as well as the aortic arch will be identified. The distance between the two structures will be measured and recorded.
Other Name: Ultrasound exam




Primary Outcome Measures :
  1. concomitant visualization of endotracheal tube cuff and aortic arch by ultrasound in situ [ Time Frame: 15 minutes ]

Secondary Outcome Measures :
  1. distance between endotracheal tube cuff and aortic arch by ultrasound in situ [ Time Frame: 15 minutes ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 85 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • requiring anesthesia with an endotracheal tube placed for surgical or procedural purposes
  • elective or stable and awake for urgent or emergent surgeries

Exclusion Criteria:

  • known tracheal deformities
  • thoracic aortic aneurysm
  • neck/chest tissue thickness making U/S scanning difficult
  • severe trauma, head injuries or any procedures that require immediate surgery

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): NCT01649882


Contacts
Contact: Kai Schoenhage, MD (520) 626-7221 kschoenhage@anesth.arizona.edu

Locations
United States, Arizona
University of Arizona Medical Center Recruiting
Tucson, Arizona, United States, 85724
Principal Investigator: Kai Schoenhage, MD         
Sponsors and Collaborators
Kai Schoenhage
Investigators
Principal Investigator: Kai Schoenhage, MD University of Arizona

Responsible Party: Kai Schoenhage, Assistant Professor, Anesthesiology Director of Perioperative Services, Director of Liver Transplant Anesthesia, Department of Anesthesiology, University of Arizona
ClinicalTrials.gov Identifier: NCT01649882     History of Changes
Other Study ID Numbers: 12-0411
First Posted: July 25, 2012    Key Record Dates
Last Update Posted: June 2, 2015
Last Verified: May 2015

Keywords provided by Kai Schoenhage, University of Arizona:
endotracheal tube position
intubation