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Clinical Trials/NCT01808183
NCT01808183
Completed
N/A

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

Wake Forest University Health Sciences1 site in 1 country90 target enrollmentFebruary 2012

Overview

Phase
N/A
Intervention
Not specified
Conditions
Supracondylar Humerus Fracture
Sponsor
Wake Forest University Health Sciences
Enrollment
90
Locations
1
Primary Endpoint
To establish the normal values of near infrared spectroscopy (NIRS) reading for pediatric forearms with and without supracondylar humerus fractures.
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 2012
End Date
February 2017
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

To establish the normal values of near infrared spectroscopy (NIRS) reading for pediatric forearms with and without supracondylar humerus fractures.

Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 72 hours

Secondary Outcomes

  • 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)

Study Sites (1)

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