Clinical Trials Directory

Trials / Completed

CompletedNCT03121794

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
Phase
Study type
Observational
Enrollment
30 (actual)
Sponsor
The Cleveland Clinic · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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%).

Conditions

Interventions

TypeNameDescription
PROCEDUREUltrasonographic examThe study team will perform an ultrasonographic exam of the proximal humerus to identify six anatomical landmarks
DEVICEultrasound machineRegular ultrasound machine used at Cleveland Clinic

Timeline

Start date
2017-04-01
Primary completion
2019-10-19
Completion
2020-07-07
First posted
2017-04-20
Last updated
2020-09-18

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03121794. Inclusion in this directory is not an endorsement.