Pediatric Supracondylar Humerus Fracture NIRS Study

Study Overview
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Brief Summary
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The purpose of this study is to use a device to compare the blood flow in the patient's injured arm to the patient's uninjured arm. This will help us determine 'normal' readings for this device for a child's forearm and may in the future help us detect children that have injured the blood vessels that go to the forearm when they have an elbow fracture. The patient will be one of approximately 100 people involved in this research project at Carolinas Medical Center, and the patient's participation will last until the patient is discharged from the hospital. It is hypothesized that if the blood vessel is uninjured, the readings on the NIRS device on the injured arm will be equal to the uninjured arm. It is also hypothesized that if the blood vessel of the injured arm is injured, the readings on the NIRS device will be different than on the uninjured arm.

Detailed Description
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Supracondylar humerus fractures (fracture just above the elbow) are common in children. Supracondylar humerus fractures account for 60% of the elbow fractures in children. Some supracondylar fractures injure the brachial artery and a small percentage of children present with an absent radial pulse after supracondylar humerus fracture, and these injuries may result in insufficient blood flow to the ipsilateral forearm. This can lead to compartment syndrome and/or ischemic contracture of the forearm muscles, and may result in permanent disability. Currently, physicians do not have objective data to determine whether or not the forearm muscles below a supracondylar humerus fracture are receiving adequate blood flow and must rely on the clinical exam of the wrist and hand distally. The purpose of this study is to use near infrared spectroscopy (NIRS) to compare the blood flow in the forearm muscle compartments of an injured arm compared to an uninjured arm. This will provide data to establish normal readings for this device for a child's forearm, and may then help clinicians detect children with insufficient perfusion of the forearm muscles after supracondylar humerus fracture.

Official Title
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Near Infrared Spectroscopy for the Evaluation of Pediatric Forearm Compartment Perfusion After Supracondylar Humerus Fracture

Conditions
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Supracondylar Humerus Fracture

Intervention / Treatment
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* Device: Near Infrared Spectroscopy Pads


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: supracondylar humerus fracture needing operative treatment ages 2-17 Exclusion Criteria: Bilateral (both sides) arm injuries Other injuries to the same arm Open fractures Previous vascular (blood vessels) injury to the upper extremity (arm) Vascular disease or insufficiency Not willing to consent to participate Only having one arm

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| supracondylar humerus fractures<br>All members of the study will have near Infrared spectroscopy pads placed on their injured and uninjured arms as a part of this study. | Device: Near Infrared Spectroscopy Pads<br>* NIRS pads are commonly used as a noninvasive method of assessing deep tissue perfusion, originally designed to assess cerebral perfusion during anesthesia.<br>* Other names: NIRS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To establish the normal values of near infrared spectroscopy (NIRS) reading for pediatric forearms with and without supracondylar humerus fractures. |  | Participants will be followed for the duration of hospital stay, an expected average of 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To correlate NIRS readings with currently utilized methods of assessing perfusion in the upper extremity following supracondylar fractures (palpation of pulse, Doppler vascular examination, capillary refill and pulse oximetry). |  | Participants will be followed for the duration of hospital stay, an expected average of 72 hours | 
| To assess the ability of NIRS measurements of forearm compartment perfusion to detect vascular injury associated with supracondylar fractures in children. |  | Participants will be followed for the duration of hospital stay, an expected average of 72 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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supracondylar, pediatric, humerus, NIRS, near Infrared spectroscopy, compartment perfusion