Ultrasonographic Identification of the Proximal Humerus Landmarks

Completed

• Conditions: Proximal Humerus Interosseous Venous Access; Ultrasonography; Anatomic Landmark
• Interventions: Procedure: Ultrasonographic exam; Device: ultrasound machine

• Registration Number: NCT03121794
• Lead Sponsor: The Cleveland Clinic

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%).

Study Timeline

• Study First Submitted: 2017-03-23
• Study Start: 2017-04-01
• Study First Submitted QC: 2017-04-17
• Study First Posted: 2017-04-20
• Primary Completion: 2019-10-19
• Study Completion: 2020-07-07
• Status Verified: 2020-08
• Last Update Submitted: 2020-09-16
• Last Update Posted: 2020-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
High BMI	ultrasound machine	Ultrasonographic identification of proximal humerus landmarks for patients with BMI \> 40 kg/m2 will receive ultrasound exam.
Low BMI	Ultrasonographic exam	Ultrasonographic identification of proximal humerus landmarks for patients with BMI 18.5 - 25 kg/m2
Low BMI	ultrasound machine	Ultrasonographic identification of proximal humerus landmarks for patients with BMI 18.5 - 25 kg/m2
Moderate BMI	Ultrasonographic exam	Ultrasonographic identification of proximal humerus landmarks for patients with BMI 30-35 kg/m2 will receive ultrasound exam.
Moderate BMI	ultrasound machine	Ultrasonographic identification of proximal humerus landmarks for patients with BMI 30-35 kg/m2 will receive ultrasound exam.
High BMI	Ultrasonographic exam	Ultrasonographic identification of proximal humerus landmarks for patients with BMI \> 40 kg/m2 will receive ultrasound exam.

Primary Outcome Measures

Name	Time	Method
Number of proximal humerus landmarks successfully identified by ultrasound exam	Through 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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States