Ultrasound Evaluation of Endotracheal Tube Depth

Intubation, Intratracheal Clinical Trial

Official title:

Ultrasound Evaluation of Endotracheal Tube Depth for Proper Tube Placement in Different Patient Groups

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01649882
• Other study ID #: 12-0411
• Status: Recruiting
• Phase: N/A
• First received: July 20, 2012
• Last updated: May 29, 2015
• Start date: July 2012
• Est. completion date: June 2016

Study information

• Verified date: May 2015
• Source: University of Arizona
• Contact: Kai Schoenhage, MD
• Phone: (520) 626-7221
• Email: kschoenhage[@]anesth.arizona.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 85 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Intubation, Intratracheal

Intervention

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.

Locations

Country	Name	City	State
United States	University of Arizona Medical Center	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Kai Schoenhage

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	concomitant visualization of endotracheal tube cuff and aortic arch by ultrasound in situ		15 minutes	Yes
Secondary	distance between endotracheal tube cuff and aortic arch by ultrasound in situ		15 minutes	Yes