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NCT02301832 · ClinicalTrials.gov registry record

Reliability of Sensor Spacing for NIRS in Traumatic Tibia Fractures

A clinical trial, sponsored by Emory University.

Completed
Registry status
14
Enrollment target

NCT02301832: Completed study, sponsored by Emory University.

NCT02301832 is a clinical trial that has completed, run by Emory University. The registered enrollment target is 14 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02301832 has completed, sponsored by Emory University.

COMPLETED
Registry status
14 participants
Enrollment target

Study Summary

This is a study intended to evaluate a non-invasive device that uses light to measure the amount of oxygen in the muscles of injured and non-injured legs in specific situations. The name of this technology is NIRS (near-infrared spectroscopy). The goal of this study is to collect the information necessary to understand the use of the NIRS monitoring system to diagnose and direct treatment decisions in case of complications sometimes experienced in traumatic tibia fracture, such as excessive swelling called acute compartment syndrome (ACS).

Primary Outcome

Assess the accuracy of the Nonin 7600 oximeter with the Sensor Model 8004CV in the diagnosis of Acute Compartment Syndrome, using the "gold standard" criterion for ACS, which will be "clinical diagnosis". That is, all subjects undergoing fasciotomy for clinically diagnosed ACS will be considered to have ACS. NIRS values will be compared to clinical diagnosis to determine accuracy and threshold values.

Trial Details

FieldValue
Enrollment Target 14 participants
Start Date 2014-12
Est. Completion 2016-07-20
Emory University

1,208 total trials

What the finished NCT02301832 record still lists

NCT02301832 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 14 participants, a relatively small participant target.

The record links to 0 conditions, and to 0 interventions.

NCT02301832 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02301832 about?

NCT02301832 is a clinical study titled "Reliability of Sensor Spacing for NIRS in Traumatic Tibia Fractures". This is a study intended to evaluate a non-invasive device that uses light to measure the amount of oxygen in the muscles of injured and non-injured legs in specific situations. The name of this technology is NIRS (near-infrared spectroscopy). The goal of this study is to collect the information nec...

What is the current status of trial NCT02301832?

This trial is currently completed. The enrollment target is 14 participants. The study started on 2014-12. Estimated completion is 2016-07-20.

Who is sponsoring clinical trial NCT02301832?

This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT02301832, the US trial registry maintained by the National Library of Medicine. NCT02301832 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.