The Use of Near Infrared Spectroscopy in the Diagnosis of Acute Compartment Syndrome in Injured Soldiers

NCT ID: NCT01123798

Last Updated: 2011-06-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-02-28

Study Completion Date

2011-01-31

Brief Summary

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The purpose of this study is to define the reliability and accuracy of Near Infrared Spectroscopy (NIRS) in the detection of intra-compartmental tissue perfusion in injured and noninjured extremities over time. The investigators hypothesize that this technology, combined with vital signs, intracompartmental pressures and clinical examinations, will be useful in diagnosing acute compartment syndrome (ACS), monitoring patients at risk for ACS, and evaluating the adequacy of fasciotomy in patients treated for ACS.

Detailed Description

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Conditions

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Acute Compartment Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Stable controls

Uninjured soldiers to provide normative data for stable physiological status

near-infrared spectroscopy

Intervention Type DEVICE

Non-invasive monitoring device applied on the surface of the skin that emits harmless red light to measure tissue perfusion.

Critical controls

Critically injured soldiers with no lower extremity traumatic injuries (excepting skin abrasions and small/superficial fragmentation wounds) to provide normative data for the "shock" physiological status.

near-infrared spectroscopy

Intervention Type DEVICE

Non-invasive monitoring device applied on the surface of the skin that emits harmless red light to measure tissue perfusion.

Lower extremity trauma

Soldiers with severe traumatic lower extremity injuries in stable and shock physiologic status. This is the investigational cohort.

near-infrared spectroscopy

Intervention Type DEVICE

Non-invasive monitoring device applied on the surface of the skin that emits harmless red light to measure tissue perfusion.

Interventions

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near-infrared spectroscopy

Non-invasive monitoring device applied on the surface of the skin that emits harmless red light to measure tissue perfusion.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 18-65 years old
* male or female
* active duty servicemen who have been evacuated from OIF or OEF through LRMC

Exclusion Criteria

* patients not willing to provide consent
* patients in whom application of NIRS monitoring is viewed as an impediment to casualty care
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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United States Department of Defense

FED

Sponsor Role collaborator

Somanetics Corporation

INDUSTRY

Sponsor Role collaborator

J&M Shuler

INDUSTRY

Sponsor Role lead

Responsible Party

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Landstuhl Regional Medical Center

Principal Investigators

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Brett Freedman, MD

Role: PRINCIPAL_INVESTIGATOR

Landstuhl Regional Medical Center

Locations

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Landstuhl Regional Medical Center

Landstuhl, , Germany

Site Status

Countries

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Germany

Other Identifiers

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DR080018-01

Identifier Type: -

Identifier Source: org_study_id

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