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Pediatric Supracondylar Humerus Fracture NIRS Study

Completed
Conditions
Supracondylar Humerus Fracture
Interventions
Device: Near Infrared Spectroscopy Pads
Registration Number
NCT01808183
Lead Sponsor
Wake Forest University Health Sciences
Brief Summary

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

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
90
Inclusion Criteria
  • supracondylar humerus fracture needing operative treatment
  • ages 2-17
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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
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Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
supracondylar humerus fracturesNear Infrared Spectroscopy PadsAll members of the study will have near Infrared spectroscopy pads placed on their injured and uninjured arms as a part of this study.
Primary Outcome Measures
NameTimeMethod
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
NameTimeMethod
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
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

Trial Locations

Locations (1)

Carolinas HealthCare System: Levine Children's Hospital

🇺🇸

Charlotte, North Carolina, United States

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