Ultrasound Evaluation of Endotracheal Tube Depth

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by University of Arizona
Sponsor:
Information provided by (Responsible Party):
Kai Schoenhage, University of Arizona
ClinicalTrials.gov Identifier:
NCT01649882
First received: July 20, 2012
Last updated: February 17, 2014
Last verified: February 2014
  Purpose

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.

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.


Condition Intervention
Intubation, Intratracheal
Procedure: US ETT (ultrasound endotracheal tube)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Ultrasound Evaluation of Endotracheal Tube Depth for Proper Tube Placement in Different Patient Groups

Further study details as provided by University of Arizona:

Primary Outcome Measures:
  • concomitant visualization of endotracheal tube cuff and aortic arch by ultrasound in situ [ Time Frame: 15 minutes ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • distance between endotracheal tube cuff and aortic arch by ultrasound in situ [ Time Frame: 15 minutes ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: July 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: US ETT
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.

  Eligibility

Ages Eligible for Study:   up to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: July 20, 2012
Last Updated: February 17, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Arizona:
endotracheal tube position
intubation

ClinicalTrials.gov processed this record on July 24, 2014