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Evaluate whether discrete landmarks of the proximal humerus can be identified using ultrasound in patients with various body habitus and BMI.
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%).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low BMI | Ultrasonographic identification of proximal humerus landmarks for patients with BMI 18.5 - 25 kg/m2 |
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| Moderate BMI | Ultrasonographic identification of proximal humerus landmarks for patients with BMI 30-35 kg/m2 will receive ultrasound exam. |
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| High BMI | Ultrasonographic identification of proximal humerus landmarks for patients with BMI > 40 kg/m2 will receive ultrasound exam. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasonographic exam | Procedure | The study team will perform an ultrasonographic exam of the proximal humerus to identify six anatomical landmarks |
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| 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:
| Through completion of ultrasonographic exam, an average of 30 minutes. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 1, 2016 | Aug 11, 2020 | Prot_SAP_000.pdf |
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| ultrasound machine | Device | Regular ultrasound machine used at Cleveland Clinic |
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Depth of each landmark from the skin in centimeters based on ultrasound measurements. |
| Through completion of ultrasonographic exam, an average of 30 minutes. |