Ultrasonographic Identification of the Proximal Humerus Landmarks

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

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

Study Overview

• Status: Completed
• Conditions: Ultrasonography; Proximal Humerus Interosseous Venous Access; Anatomic Landmark
• Intervention / Treatment: Procedure: Ultrasonographic exam; Device: ultrasound machine

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 Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participants will be selected after chart review of current patients undergoing general, cardiac, thoracic, or vascular surgery. Patients will be approached in the preoperative clinic or during their hospitalization (preoperatively or postoperatively). Informed consent will be obtained prior to performing the study.

Participants will be separated into 3 cohorts based on BMI. The number of participants in each cohort is as follows: 10 patients with BMI 18.5 - 25 kg/m2; 10 patients with BMI 30-35 kg/m2, 10 patients with BMI > 40 kg/m2.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.

Collaborators and Investigators

• Sponsor: The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2017
• Primary Completion (Actual): October 19, 2019
• Study Completion (Actual): July 7, 2020

Study Registration Dates

• First Submitted: March 23, 2017
• First Submitted That Met QC Criteria: April 17, 2017
• First Posted (Actual): April 20, 2017

Study Record Updates

• Last Update Posted (Actual): September 18, 2020
• Last Update Submitted That Met QC Criteria: September 16, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: ultrasonography; humerus; Intraosseous Vascular access; anatomic landmark
• Other Study ID Numbers: 16-1642

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No