Ultrasonographic Identification of the Proximal Humerus Landmarks

Ultrasonography Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03121794
• Other study ID #: 16-1642
• Status: Completed
• Start date: April 1, 2017
• Est. completion date: July 7, 2020

Study information

• Verified date: August 2020
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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%).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 7, 2020
• Est. primary completion date: October 19, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anatomic Landmark
• Proximal Humerus Interosseous Venous Access
• Ultrasonography

Intervention

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

Device:
• ultrasound machine
Regular ultrasound machine used at Cleveland Clinic

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of proximal humerus landmarks successfully identified by ultrasound exam	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: The humeral shaft,; The surgical neck of the humerus,; The lesser tubercle,; The greater tubercle,; The intertubercular sulcus; 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.	Through completion of ultrasonographic exam, an average of 30 minutes.
Secondary	Time used to identify all 6 anatomical landmarks using ultrasound in seconds.	Evaluate the time used to identify all 6 anatomical landmarks using ultrasound.	Through completion of ultrasonographic exam, an average of 30 minutes.
Secondary	Depth of each landmark from the skin in centimeters.	Depth of each landmark from the skin in centimeters based on ultrasound measurements.	Through completion of ultrasonographic exam, an average of 30 minutes.