Clinical trial NCT01808183: Pediatric Supracondylar Humerus Fracture NIRS Study
Official title: Near Infrared Spectroscopy for the Evaluation of Pediatric Forearm Compartment Perfusion After Supracondylar Humerus Fracture
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Supracondylar Humerus Fracture
Keywords: supracondylar
pediatric
humerus
NIRS
near Infrared spectroscopy
compartment perfusion
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2013-03-11
Enrollment: 90
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children presenting to the Levine Children's Hospital / CMC Emergency Department with displaced supracondylar fractures.

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.

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

Primary outcomes:
measure: To establish the normal values of near infrared spectroscopy (NIRS) reading for pediatric forearms with and without supracondylar humerus fractures.
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 72 hours
Secondary outcomes:
measure: 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).
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 72 hours
measure: To assess the ability of NIRS measurements of forearm compartment perfusion to detect vascular injury associated with supracondylar fractures in children.
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 72 hours
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Carolinas HealthCare System: Levine Children's Hospital
state: North Carolina
Study officials:
affiliation: Carolinas Medical Center
name: Brian Scannell, MD
role: PRINCIPAL_INVESTIGATOR
References:
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