Pediatric Supracondylar Humerus Fracture NIRS Study

NCT01808183 | Completed DMC

• 1 other identifier: 20-10-13B
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Supracondylar Humerus Fracture

Keywords

supracondylar; pediatric; humerus; NIRS; near Infrared spectroscopy; compartment perfusion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (1)

supracondylar humerus fractures

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

Interventions

Near Infrared Spectroscopy Pads DEVICE

NIRS pads are commonly used as a noninvasive method of assessing deep tissue perfusion, originally designed to assess cerebral perfusion during anesthesia.

Also known as: NIRS pad, NIRS

supracondylar humerus fractures

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children presenting to the Levine Children's Hospital / CMC Emergency Department with displaced supracondylar fractures.

You may qualify if:

• supracondylar humerus fracture needing operative treatment
• ages 2-17

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Carolinas HealthCare System: Levine Children's Hospital

Charlotte, North Carolina, 28204, United States

Location

Related Publications (11)

• 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. doi: 10.1097/01241398-199501000-00011.

  PMID: 7883927 BACKGROUND

• 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.

  PMID: 20502231 BACKGROUND

• 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.

  PMID: 20032742 BACKGROUND

• 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. doi: 10.1097/00003086-200007000-00010.

  PMID: 10906859 BACKGROUND

• 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. doi: 10.1016/s0020-1383(02)00312-1.

  PMID: 12667778 BACKGROUND

• 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.

  PMID: 18451407 BACKGROUND

• Styf J. Evaluation of injection techniques in recording of intramuscular pressure. J Orthop Res. 1989;7(6):812-6. doi: 10.1002/jor.1100070606.

  PMID: 2795320 BACKGROUND

• 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. doi: 10.2106/JBJS.D.02826.

  PMID: 16264116 BACKGROUND

• 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.

  PMID: 12131436 BACKGROUND

• 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.

  PMID: 19487513 BACKGROUND

• Tobias JD, Hoernschemeyer DG. Near-infrared spectroscopy identifies compartment syndrome in an infant. J Pediatr Orthop. 2007 Apr-May;27(3):311-3. doi: 10.1097/BPO.0b013e3180326591.

  PMID: 17414016 BACKGROUND

Study Officials

• Brian Scannell, MD

  Carolinas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2013
• First Posted: March 11, 2013
• Study Start: February 1, 2012
• Primary Completion: December 1, 2016
• Study Completion: February 1, 2017
• Last Updated: April 27, 2022

Record last verified: 2017-08

Locations

US (1)