NCT02301832

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 24, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 26, 2014

Completed
5 days until next milestone

Study Start

First participant enrolled

December 1, 2014

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2016

Completed
Last Updated

February 6, 2017

Status Verified

February 1, 2017

Enrollment Period

1.6 years

First QC Date

November 24, 2014

Last Update Submit

February 3, 2017

Conditions

Orthopedic DisordersTibial Fractures

Keywords

acute compartment swelling (ACS)near-infrared spectroscopy (NIRS)

Outcome Measures

Primary Outcomes (1)

  • NIRS measurements as compared to clinical findings

    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.

    Participants will be followed for the duration of hospital stay, an expected average of 72 hours

Secondary Outcomes (2)

  • Accuracy of NIRS measurements compared to Intracompartmental pressure (ICP) measurements

    Participants will be followed for the duration of hospital stay, an expected average of 72 hours

  • Correlation between NIRS measurements between injured and uninjured extremity

    Participants will be followed for the duration of hospital stay, an expected average of 72 hours

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects will be recruited from the trauma bay, surgical wards and ICU of Grady Memorial Hospital.

You may qualify if:

  • Unilateral leg injury
  • Enrolled within 48 hours of injury
  • Subjects with 'severe' leg injuries presenting at trauma center that meet at least one of the following from each group below:
  • Anatomic location:
  • Tibia/Fibula shaft fracture
  • Tibial plateau fracture (Schatzker III-VI)
  • High Energy Mechanism of Injury:
  • Fall from \>8 foot height
  • Motor vehicle collision (\> 15 mph)
  • Motor vehicle versus pedestrian accident
  • High velocity gunshot wound
  • Crush injury
  • Sport/recreation

You may not qualify if:

  • Application of NIRS monitoring would be an impediment to care
  • Known prior leg fractures, patient has already undergone fasciotomy of the injured leg prior to enrollment
  • History of peripheral vascular disease or concurrent lower extremity vascular injury/surgery
  • Admission for atraumatic medical reasons
  • Subject is unable to provide informed consent, or consent cannot be obtained from a legally authorized representative
  • Complete spinal cord injuries, bilateral upper extremity injuries, or amputation/mangled lower extremity
  • Patients who are in police custody at presentation to the hospital or who are pregnant
  • Patient has an open injury on the injured leg that is large enough that at least one NIRS sensor cannot be safely placed over the compartment
  • Bilateral leg injuries
  • Not able to be enrolled within 48 hours after injury

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Grady Memorial Hospital

Atlanta, Georgia, 30303, United States

Location

MeSH Terms

Conditions

Musculoskeletal DiseasesTibial Fractures

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesLeg Injuries

Study Officials

  • William Reisman, MD

    Emory University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
William Reisman MD

Study Record Dates

First Submitted

November 24, 2014

First Posted

November 26, 2014

Study Start

December 1, 2014

Primary Completion

July 20, 2016

Study Completion

July 20, 2016

Last Updated

February 6, 2017

Record last verified: 2017-02

Locations

US(1)