Ultrasound Evaluation of Endotracheal Tube Depth

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

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.

Study Overview

• Status: Unknown
• Conditions: Intubation, Intratracheal
• Intervention / Treatment: Procedure: US ETT (ultrasound endotracheal tube)

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
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85724
      • Recruiting
      • University of Arizona Medical Center
      • Principal Investigator: Kai Schoenhage, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 85 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: Ultrasound exam

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
concomitant visualization of endotracheal tube cuff and aortic arch by ultrasound in situ	15 minutes

Secondary Outcome Measures

Outcome Measure	Time Frame
distance between endotracheal tube cuff and aortic arch by ultrasound in situ	15 minutes

Collaborators and Investigators

• Sponsor: Kai Schoenhage

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Anticipated): December 1, 2015
• Study Completion (Anticipated): June 1, 2016

Study Registration Dates

• First Submitted: July 20, 2012
• First Submitted That Met QC Criteria: July 24, 2012
• First Posted (Estimate): July 25, 2012

Study Record Updates

• Last Update Posted (Estimate): June 2, 2015
• Last Update Submitted That Met QC Criteria: May 29, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: intubation; endotracheal tube position
• Other Study ID Numbers: 12-0411