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Pediatric Supracondylar Humerus Fracture NIRS Study

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ClinicalTrials.gov Identifier: NCT01808183
Recruitment Status : Completed
First Posted : March 11, 2013
Last Update Posted : August 10, 2017
Sponsor:
Information provided by (Responsible Party):
Brian Brighton, Atrium Health

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.

Condition or disease Intervention/treatment
Supracondylar Humerus Fracture Device: Near Infrared Spectroscopy Pads

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.

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Study Type : Observational
Actual Enrollment : 90 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Near Infrared Spectroscopy for the Evaluation of Pediatric Forearm Compartment Perfusion After Supracondylar Humerus Fracture
Study Start Date : February 2012
Actual Primary Completion Date : December 2016
Actual Study Completion Date : February 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
NIRS pads are commonly used as a noninvasive method of assessing deep tissue perfusion, originally designed to assess cerebral perfusion during anesthesia.
Other Names:
  • NIRS pad
  • NIRS




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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). [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 72 hours ]
  2. To assess the ability of NIRS measurements of forearm compartment perfusion to detect vascular injury associated with supracondylar fractures in children. [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 72 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children presenting to the Levine Children's Hospital / CMC Emergency Department with displaced supracondylar fractures.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01808183


Locations
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United States, North Carolina
Carolinas HealthCare System: Levine Children's Hospital
Charlotte, North Carolina, United States, 28204
Sponsors and Collaborators
Atrium Health
Investigators
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Principal Investigator: Brian Scannell, MD Carolinas Medical Center

Publications:

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Responsible Party: Brian Brighton, Pediatric Orthopaedic Surgeon, Atrium Health
ClinicalTrials.gov Identifier: NCT01808183     History of Changes
Other Study ID Numbers: 20-10-13B
First Posted: March 11, 2013    Key Record Dates
Last Update Posted: August 10, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: undecided

Keywords provided by Brian Brighton, Atrium Health:
supracondylar
pediatric
humerus
NIRS
near Infrared spectroscopy
compartment perfusion

Additional relevant MeSH terms:
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Fractures, Bone
Humeral Fractures
Wounds and Injuries
Arm Injuries