Pediatric Supracondylar Humerus Fracture NIRS Study

Supracondylar Humerus Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01808183
• Other study ID #: 20-10-13B
• Status: Completed
• Start date: February 2012
• Est. completion date: February 2017

Study information

• Verified date: August 2017
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: February 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Humeral Fractures
• Supracondylar Humerus Fracture

Intervention

Device:
• Near Infrared Spectroscopy Pads
NIRS pads are commonly used as a noninvasive method of assessing deep tissue perfusion, originally designed to assess cerebral perfusion during anesthesia.

Locations

Country	Name	City	State
United States	Carolinas HealthCare System: Levine Children's Hospital	Charlotte	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

References & Publications (11)

Battaglia TC, Armstrong DG, Schwend RM. Factors affecting forearm compartment pressures in children with supracondylar fractures of the humerus. J Pediatr Orthop. 2002 Jul-Aug;22(4):431-9. — View Citation

Boody AR, Wongworawat MD. Accuracy in the measurement of compartment pressures: a comparison of three commonly used devices. J Bone Joint Surg Am. 2005 Nov;87(11):2415-22. — View Citation

Campbell CC, Waters PM, Emans JB, Kasser JR, Millis MB. Neurovascular injury and displacement in type III supracondylar humerus fractures. J Pediatr Orthop. 1995 Jan-Feb;15(1):47-52. — View Citation

Choi PD, Melikian R, Skaggs DL. Risk factors for vascular repair and compartment syndrome in the pulseless supracondylar humerus fracture in children. J Pediatr Orthop. 2010 Jan-Feb;30(1):50-6. doi: 10.1097/BPO.0b013e3181c6b3a8. — View Citation

Gosens T, Bongers KJ. Neurovascular complications and functional outcome in displaced supracondylar fractures of the humerus in children. Injury. 2003 May;34(4):267-73. — View Citation

Lyons ST, Quinn M, Stanitski CL. Neurovascular injuries in type III humeral supracondylar fractures in children. Clin Orthop Relat Res. 2000 Jul;(376):62-7. — View Citation

Omid R, Choi PD, Skaggs DL. Supracondylar humeral fractures in children. J Bone Joint Surg Am. 2008 May;90(5):1121-32. doi: 10.2106/JBJS.G.01354. Review. — View Citation

Shuler MS, Reisman WM, Whitesides TE Jr, Kinsey TL, Hammerberg EM, Davila MG, Moore TJ. Near-infrared spectroscopy in lower extremity trauma. J Bone Joint Surg Am. 2009 Jun;91(6):1360-8. doi: 10.2106/JBJS.H.00347. — View Citation

Styf J. Evaluation of injection techniques in recording of intramuscular pressure. J Orthop Res. 1989;7(6):812-6. — View Citation

Tobias JD, Hoernschemeyer DG. Near-infrared spectroscopy identifies compartment syndrome in an infant. J Pediatr Orthop. 2007 Apr-May;27(3):311-3. — View Citation

White L, Mehlman CT, Crawford AH. Perfused, pulseless, and puzzling: a systematic review of vascular injuries in pediatric supracondylar humerus fractures and results of a POSNA questionnaire. J Pediatr Orthop. 2010 Jun;30(4):328-35. doi: 10.1097/BPO.0b013e3181da0452. Review. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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