Ultrasound Evaluation of Endotracheal Tube Depth

NCT ID: NCT01649882

Last Updated: 2015-06-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2016-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Intubation, Intratracheal

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

US ETT (ultrasound endotracheal tube)

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Other Intervention Names

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Ultrasound exam

Eligibility Criteria

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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
Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kai Schoenhage

OTHER

Sponsor Role lead

Responsible Party

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Kai Schoenhage

Assistant Professor, Anesthesiology Director of Perioperative Services, Director of Liver Transplant Anesthesia, Department of Anesthesiology

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Kai Schoenhage, MD

Role: PRINCIPAL_INVESTIGATOR

University of Arizona

Locations

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University of Arizona Medical Center

Tucson, Arizona, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Kai Schoenhage, MD

Role: CONTACT

(520) 626-7221

Other Identifiers

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12-0411

Identifier Type: -

Identifier Source: org_study_id

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