Ultrasonographic Identification of the Proximal Humerus Landmarks

NeuroTherapia, Inc.

Status: Completed

Conditions: Ultrasonography; Anatomic Landmark; Proximal Humerus Interosseous Venous Access

Treatments: Procedure: Ultrasonographic exam; Device: ultrasound machine

Study type: Observational

Funder types: Other

Identifiers

NCT03121794

16-1642

Details and patient eligibility

About

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

Full 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%).

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

30 participants in 3 patient groups

Low BMI

Description:

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

Treatment:

Device: ultrasound machine

Procedure: Ultrasonographic exam

Moderate BMI

Description:

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

Treatment:

Device: ultrasound machine

Procedure: Ultrasonographic exam

High BMI

Description:

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

Treatment:

Device: ultrasound machine

Procedure: Ultrasonographic exam