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Ultrasonographic Identification of the Proximal Humerus Landmarks

Ultrasonographic Identification of the Proximal Humerus Landmarks for Intra-Osseous Vascular Access Across Different Body Habitus

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03121794
Enrollment
30
Registered
2017-04-20
Start date
2017-04-01
Completion date
2020-07-07
Last updated
2020-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Proximal Humerus Interosseous Venous Access, Anatomic Landmark, Ultrasonography

Keywords

ultrasonography, Intraosseous Vascular access, humerus, anatomic landmark

Brief summary

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

Detailed description

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%).

Interventions

PROCEDUREUltrasonographic exam

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

Regular ultrasound machine used at Cleveland Clinic

Sponsors

The Cleveland Clinic
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of proximal humerus landmarks successfully identified by ultrasound examThrough completion of ultrasonographic exam, an average of 30 minutes.Two investigators will perform an ultrasonographic exam on each patient, with one investigator examining each side of the body. Each investigator will aim to identify 6 anatomical landmarks: 1. The humeral shaft, 2. The surgical neck of the humerus, 3. The lesser tubercle, 4. The greater tubercle, 5. The intertubercular sulcus 6. The target site in the greater tubercle for needle insertion. Each side will receive a score ranging from 0 to 6 corresponding to the number of landmarks correctly identified.

Secondary

MeasureTime frameDescription
Time used to identify all 6 anatomical landmarks using ultrasound in seconds.Through completion of ultrasonographic exam, an average of 30 minutes.Evaluate the time used to identify all 6 anatomical landmarks using ultrasound.
Depth of each landmark from the skin in centimeters.Through completion of ultrasonographic exam, an average of 30 minutes.Depth of each landmark from the skin in centimeters based on ultrasound measurements.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026