Ultrasonographic Identification of the Proximal Humerus Landmarks

NCT ID: NCT03121794

Last Updated: 2020-09-18

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

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-04-01

Study Completion Date

2020-07-07

Brief Summary

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Evaluate whether discrete landmarks of the proximal humerus can be identified using ultrasound in patients with various body habitus and BMI.

Detailed Description

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There are three main forms of vascular access: peripheral intravenous (PIV), Central venous (CV) and intraosseous (IO). Of the different types of vascular access PIV and CV access have drawbacks when used during resuscitation, because they can be difficult to obtain when patients are volume depleted as in cases of trauma. Attempting CV access has numerous risks with complications occurring in up to 33% of attempts. These include failed placement (22%), arterial puncture (5%), catheter malposition (4%), pneumothorax (1%) and asystolic cardiac arrest (\<1%). Attempting to obtain CV access may also disrupt chest compressions in cases of cardiac arrest. Intraosseous access has been used in scenarios where PIV and CV access is difficult or impossible to obtain. Pharmacokinetic studies and standard practice support the bioequivalence of intraosseous and intravenous administration of common medications. Intravascular depletion does not hinder attempts at IO access, and as the insertion sites are peripheral to the heart, insertion can be done avoiding interruptions in chest compressions. Obtaining proximal humerus interosseous (PHIO) access may also be faster than obtaining both PIV and CV access with a relatively low complication rate. In one survey, complications of IO included difficulty in identifying correct anatomical site (3%), extravasation (3.7%), displacement after insertion (8.5%), and very rarely late complications including compartment syndrome (0.6%), osteomyelitis (0.4%) and skin infection (0.3%).

Conditions

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Proximal Humerus Interosseous Venous Access Anatomic Landmark Ultrasonography

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Low BMI

Ultrasonographic identification of proximal humerus landmarks for patients with BMI 18.5 - 25 kg/m2

Ultrasonographic exam

Intervention Type PROCEDURE

The study team will perform an ultrasonographic exam of the proximal humerus to identify six anatomical landmarks

ultrasound machine

Intervention Type DEVICE

Regular ultrasound machine used at Cleveland Clinic

Moderate BMI

Ultrasonographic identification of proximal humerus landmarks for patients with BMI 30-35 kg/m2 will receive ultrasound exam.

Ultrasonographic exam

Intervention Type PROCEDURE

The study team will perform an ultrasonographic exam of the proximal humerus to identify six anatomical landmarks

ultrasound machine

Intervention Type DEVICE

Regular ultrasound machine used at Cleveland Clinic

High BMI

Ultrasonographic identification of proximal humerus landmarks for patients with BMI \> 40 kg/m2 will receive ultrasound exam.

Ultrasonographic exam

Intervention Type PROCEDURE

The study team will perform an ultrasonographic exam of the proximal humerus to identify six anatomical landmarks

ultrasound machine

Intervention Type DEVICE

Regular ultrasound machine used at Cleveland Clinic

Interventions

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Ultrasonographic exam

The study team will perform an ultrasonographic exam of the proximal humerus to identify six anatomical landmarks

Intervention Type PROCEDURE

ultrasound machine

Regular ultrasound machine used at Cleveland Clinic

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Males or females 18 years of age or older undergoing general, cardiac, thoracic or vascular surgery.
* BMI \>= 18.5 kg/m\^2

Exclusion Criteria

* Limited mobility/ range of motion of arms
* Prior surgical intervention on shoulder or humerus
* History of arm dislocation with internal rotation
* History of arm fracture
* BMI in ranges: 25.1 - 29.9, 35.1 - 39.9
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Cleveland Clinic

OTHER

Sponsor Role lead

Responsible Party

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SergioB17

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cleveland Clinic

Cleveland, Ohio, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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16-1642

Identifier Type: -

Identifier Source: org_study_id

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